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- SK Bioscience loses MSD vaccines but nabs GSK vaccines?
- by Kim, Jin-Gu Jan 06, 2021 06:19am
- SK Bioscience is reportedly sealing the deal on commercializing four types of GSK vaccines in South Korea. When the deal is finalized, SK Bioscience would be able to fill the gap of four types of MSD vaccinea taken over by HK inno.N last year. According to a pharmaceutical industry source on Jan. 5, SK Bioscience and GSK Korea are in discussion for co-promotion contracts on a cervical cancer vaccine Cervarix, a hepatitis A virus vaccine Havrix, a meningococcal vaccine Menveo, and a Tdap vaccine Boostrix. SK Bioscience and GSK Korea left no official comments, but the industry seems to be aware that the two companies are close to inking the co-promotion deal. Since late last year, the local sales licenses for the global pharmaceutical companies’ vaccines have been shuffled around. In last November, seven MSD vaccines’ sales licenses, previously owned by GC Pharma and SK Bioscience, have been handed over to HK inno.N. Apparently, the Korean company started taking actions from the break of the new year. The seven MSD vaccines included cervical cancer vaccine Gardasil 4 and 9, a shingles vaccine Zostavax, a rotavirus vaccine RataTeq, a hepatitis A virus vaccine Vaqta, a measles, mumps, and rubella vaccine MMR2, and a pneumococcal vaccine Prodiax. The popular vaccines like Zostavax and Gardasil were handled by GC Pharma, and the rest of the vaccines—RotaTeq, Vaqta, MMR2 and Prodiax—were sold by SK Bioscience. Zostavax and Gardasil raised 120 billion won a year, whereas RotaTeq, Vaqta, MMR2 and Prodiax generated approximately 24 billion won a year. In just two months, SK Bioscience is getting its hands on GSK vaccines. Currently, four GSK vaccines are sold by Yuhan Corporation and Kwangdong Pharmaceutical, each focused on sales in children and adolescents, and in the rest of the target, respectively. The industry experts expect SK Bioscience would nab the vaccines sold by Yuhan. GSK has reportedly suspended the supply of vaccine to Yuhan as of Dec. 31, 2020. If SK Bioscience successfully signs the co-promotion deal on the four vaccines by GSK, the company would be able to compensate the loss from losing MSD’s Cervarix, Havrix, Menveo, and Boostrix, which used to generated 28 billion won annually. A pharmaceutical industry insider commented, “GSK has cut the ties with Yuhan for the new contract. Highly likely that SK Bioscience would take over all the vaccine sales and marketing, except for the pediatric market. However, both SK Bioscience and GSK are reserving any definite answer. SK Bioscience official explained, “We have no comment to make on the domestic sales licenses on GSK vaccines.” GSK official also stated, “There is nothing to confirm except that the talk is in progress.”
- Company
- Patient copayment on Dupixent drops from 60% to 10%
- by Jan 06, 2021 06:18am
- From the break of the new year, the copayment burden on the patients prescribed with an atopic dermatitis treatment Dupixent would be reduced significantly. Sanofi Aventis Korea’s Dupixent would be applied with a special case reimbursement from Jan. 1, 2021 for the patients with severe case of atopic dermatitis. Accordingly, their copayment rate for administering 300 mg of Dupixent would be decreased from 60 percent to 10 percent. The Health Insurance Policy Deliberation Committee (HIPDC) has made the decision at the 22nd meeting convened by the Ministry of Health and Welfare (MOHW) on Nov. 27 last year. A special case reimbursement benefit is provided to patients with rare or severe chronic diseases to cut their copayment rate for the healthcare reimbursement down to 10 percent. To this date, atopic dermatitis was ruled out of the special case benefit as there was no distinction between mild and severe cases. But the relevant legal basis has changed since last July, when a new disease code was designated to a ‘severe case of atopic dermatitis.’ The government also rapidly processed the changes. Now the patients prescribed with Dupixent can only pay 71,000 won, the 10 percent of the listed price 710,000 won per shot. The annual cost of the treatment is estimated to be around 2 million won. Compared to last year, the cost would be maximum 5.82 million won less or about the half. However, the special case reimbursement is only granted to patients who meet the requirements; treating adult patient over the age of 18 with severe atopic dermatitis apparent for over three years, who has uncontrolled condition after four-week topical treatment as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy; has EASI score over 23 before administrating the treatment; and has a record of receiving topical treatment and systemic immunosuppressant therapy within past six months. The Dupixent sales are also expected to surge even more this year as the copayment rate dropped drastically from the New Year’s Day. A pharmaceutical market research firm IQVIA reported Dupixent’s sales income has skyrocketed since last year’s January, when the healthcare reimbursement was granted. The initial quarterly sales making approximately 1 billion won to 2 billion won leaped to 3.3 billion won in last year’s first quarter, and also it soared to 5.2 billion won and 7.1 billion won in the second and third quarters, respectively. As the injection sales accumulated 15.6 billion won as of last year third quarter, Dupixent would likely to break through the 20 billion won record in the first year of reimbursement. Meanwhile, the special case benefit and reimbursement are not applicable on Dupixent 200 mg. The lower dose is currently approved only for adolescents with atopic dermatitis and asthma cases. Sanofi Aventis informed of the detail and explained, “The healthcare reimbursement is not granted for Dupixent 200 mg, so the patients would have to wholly cover the cost of administration.”
- Company
- Industry busy with M&A and investment for new opportunity
- by Chon, Seung-Hyun Dec 31, 2020 06:21am
- In the year 2020, many of South Korean pharmaceutical companies turned their eyes on new potential businesses. They reported major M&A news more than before. Some of them also took a bold step into bio company investment to find new opportunities. ◆GC and Celltrion ink notable M&A deals in hopes of finding new lucrative businesses The industry paid a close attention on GC as it delivered the news of finalizing two big M&A deals. GC Healthcare paid 208.8 billion won in last February to acquire an IT company UB Care. GC Healthcare is a subsidiary of GC that provides customized healthcare service based on IT. UB Care is South Korea’s number one electronic medical record (EMR) solution company, which developed EMR system for the first time in the country. It owns Korea’s biggest medical network and IT-based business platform consisting of 23,900 hospitals and clinics nationwide. Green Cross Holdings anticipates the existing business sectors covering traditional pharmaceutical business, genetic testing, diagnostic testing, medical checkup and many more would maximize the synergy effect in various healthcare sectors after it merges with UB Care. Moreover, bio companies have also joined the colossal M&A market. In last June, Celltrion signed a deal to take over the rights to Takeda’s Primary Care product assets from the Asia-Pacific markets for a total of USD 278 million (approximately 330 billion won). The deal would grant the company all rights over the 18 products available in nine markets including South Korea, Thailand, Taiwan, Hong Kong, Macao, the Philippines, Singapore, Malaysia and Australia. The list of the product assets ranges from prescription drugs like antidiabetic drug ‘Nesina’ and ‘Actos,’ antihypertensive drug ‘Edarbi,’ to OTC drugs like cold drug ‘Whituben’ and stomatitis drug ‘Albothyl.’ In last September, HLB Group acquired Mediforum (previously C-Tri). HLB, HLB Life Science and top shareholders of HLB invested total 16.6 billion won. A biopharmaceutical company Vivozon used its subsidiary to merge with Inist Bio Pharmaceutical. Lumimicro inked a contract to obtain 89.57 percent of Inist Bio Pharmaceutical shares for 60.9 billion won. After merging with the company, Lumimicro re-launched itself as Vivozon Healthcare. Lumimicro manufactures and sells compound semiconductor. Ultimately, Vivozon is merging with Inist Bio Pharmaceutical and taking over the company’s management. Established in 2008, Vivozon is a biopharmaceutical company developing new drugs. Currently, the company is conducting a clinical trial to develop non-narcotic painkiller ‘VVZ-149’ administering to manage post-surgery pain and neuropathic pain. Regardless of the failed attempt to merge, Genexine successfully acquired Toolgen. Genexine secured 16.64 percent of Toolgen’s share and became the biggest shareholder of the company. .Genexine is currently developing immunotherapy and gene vaccine .At the moment, the company is working on global clinical trials in immunotherapy ‘hyleukin-7’ and gene vaccine against cervical cancer .Toolgen owns source technology on third generation CRISPR/Cas9 genome editing, which the company uses it to develop gene therapy .◆Yuhan, Boryung and Huons actively invest externally The pharmaceutical companies were particularly active this year in investing on biopharmaceutical companies .By shaking hands with bio companies for R&D partnership, the pharmaceutical companies aim to seek the next big opportunity .Yuhan Corporation has been fruitful with lazertinib the company took over from Oscotec and licensed out to Janssen .Yuhan spent 38 billion won on four companies as equity investment .In April, the South Korean company invested in Mediogen for 23 billion won .Specializing in probiotics, Mediogen is the biggest shareholder of GI Innovation with 20.79 percent of the share .With Mediogen’s 19.82 percent share gained, Yuhan is now the second biggest shareholder of the company .The company invested quadruple of its last year operating income at 12.5 billion won in an external company for emerging opportunity .Early this year, Yuhan also invested total 15 billion won, or 5 billion won each on Huinno, Amyloid Solution and GI-Biome .Boryung Pharmaceutical reported its nine outward investments took place this year spending total 29.1 billion won .In last July, Boryung Pharmaceutical had decided to invest 24 billion won on a U.S.-based global healthcare investment fund Hayan1 L.P, an investment fund company operated by Boryung’s U.S .branch Hayan Health Network, established for the purpose of healthcare sector investment .Hayan1 fund would seek and invest on promising global bio venture based on 24 billion won Boryung paid out .
- Company
- Celltrion has applied for approval of COVID-19 treatment
- by Chon, Seung-Hyun Dec 31, 2020 06:20am
- Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review. Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment. An application for authorization was filed based on the recently ended global phase II clinical trial. CelltrionBased on the clinical results, Celltrion is also starting a procedure for obtaining EUA in the US and Europe. This global clinical phase II was designed through prior consultation with the MFDS the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). A total of 327 patients from South Korea, Romania, Spain and the United States participated and completed the final medication on November 25th. Celltrion explained, “We have completed the analysis of the detailed data of this clinical trial through domestic and foreign experts and self-evaluation, and have immediately submitted an application for approval because we have determined that we have secured sufficient grounds for applying for accelerated approval from the Ministry of Food and Drug Safety for CT-P59. The MFDS requested that detailed clinical data related to the safety and efficacy of CT-P59 be not disclosed until there is a separate guideline, in view of the recent focus of the public on COVID-19 treatment. Celltrion plans to present the results of this phase II clinical trial in detail at an international conference soon. In addition, based on the results, it plans to quickly enter phase III clinical trials in 10 countries around the world to further verify the safety and efficacy of CT-P59 through a broader patient group. Celltrion is also promoting the overseas Emergency Use Authorization (EUA) procedure of CT-P59. While sharing the data on the results of this phase II clinical trial in detail with the FDA and EMA, consultations on the submission of applications for approval will be initiated, and They will be submitted to most of these countries in January of next year. When responding to inquiries about orders from overseas government agencies, it plans to induce pre-orders while explaining the results of this phase II clinical trial in detail so that domestic supply is possible as soon as possible as soon as EUA is available. An official from Celltrion said, “We are grateful to domestic and foreign health authorities, medical institutions, and participating patients who have actively supported this clinical trial to be completed smoothly as planned. Special thanks are also to the dozens of our employees who have been dedicated to working in the US and Europe.” The MFDS has initiated the CT-P59 permit review process. The MFDS explained, "As Celltrion submitted the application for permission and related data, the approval review began." The submitted data is preliminary reviewed by the high-tech product licensing officer, and then a pre-configured “COVID-19 Vaccine/Therapeutic License Review Team” examines the data necessary for approval, such as non-clinical, clinical, and quality. After that, the review opinions are synthesized to determine the validity of the permit, and the final approval is obtained after consulting the Central Pharmaceutical Affairs Review Committee composed of external experts. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. An official from the MFDS explained, "We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of COVID-19 Vaccine and Treatment License Examination Team so that safe and effective COVID-19 treatment can be used by the public."
- Company
- Who would manufacture Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 31, 2020 06:20am
- President Moon Jae-in and Moderna CEO Stephane Bancel reportedly had a conference call over supplying COVID-19 vaccines for 20 million people in South Korea. Now the question is who would sign the consignment production contract for the vaccine in South Korea. The pharmaceutical industry is mentioning four names of potential candidates, including GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm. ◆Cheong Wa Dae “Strengthening collaboration with Korean CMO for the vaccine” On Dec. 29, Cheong Wa Dae stated the South Korean government plans to reach a purchasing agreement over COVID-19 vaccine for 20 million people with Moderna by the end of the year. Compared to the original plan, the number of doses was increased to vaccinate 10 million more people, and the supply schedule was push up from the third quarter to the second quarter. Also the presidential office disclosed the plan to secure Moderna vaccine through consignment production. Cheong Wa Dae spokesperson Kang Min-seok said, “We have agreed to strengthen the cooperation with Moderna by having South Korean company to manufacture the vaccine under consignment contract.” If the government finalizes the supply contract with Moderna, it would resemble that of the AstraZeneca’s vaccine contract. In last July, the government has inked a three-way contract with AstraZeneca and SK Bioscience for the vaccine supply. The pharmaceutical industry predicts GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm would have a chance at it. ◆Top candidates: GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm GC Pharma has been mentioned as a candidate backed by the company’s Ochang manufacturing facility opened in October. The facility has integrated each vaccine facility previously located in Hwasun and Ochang, Jellanam-do. GC Pharma has also signed a facility utilization contract with Coalition for Epidemic Preparedness Innovations (CEPI) in last October. Basically, the Korean company has agreed to manufacture 500 million doses, if a vaccine developer (including Moderna) successfully develops a vaccine supported by CEPI. According to the agreement, the company plans to manufacture COVID-19 vaccine assigned by CEPI from March 2021 to May 2022. CEPI is part of COVAX Facility along with WHO and GAVI. South Korea has signed to receive vaccines for 10 million people through COVAX Facility, but the said doses are not part of the deal the government and Moderna is lately discussing of. Hanmi Pharmaceutical is also on the list of the Moderna vaccine CMO candidates. The company’s Peongtaek Bio Plant can manufacture maximum 1 billion doses of vaccines per year. Two years ago, Hanmi Pharmaceutical has completed constructing a Bio Plant equipped with 20,000 liter of microbial fermentation and biochemical conjugation reaction processors. Apparently, the plant can manufacture 20 million doses of mRNA vaccine in a week. Along with GC Pharma and Hanmi Pharmaceutical, ST Pharm is mentioned as a manufacturer candidate as the company has been consistently preparing for mass production of mRNA vaccine. Since three years ago, the South Korean company forecasted an anticancer vaccine using mRNA mechanism would be promising and started expanding relevant facilities. On Dec. 2, the company opened mRNA Business Development Department directly under the CEO’s command as an expansion of emerging business, and recruited a gene therapy expert Dr. Yang Joo-sung as the department head. Also the company is reinforcing the related facility as well. However, ST Pharm is backed up with other consignment contracts, and it still lacks the capacity to mass produce mRNA vaccine. Another candidate Samsung Biologics has the world’s biggest biopharmaceutical production capacity. The company has already signed consignment production deals with various global pharmaceutical companies for COVID-19 treatments. Regardless of the colossal facility, the company would have to newly establish facility to mass produce mRNA vaccine. A pharmaceutical CMO industry insider noted, “Moderna would likely to license out the technology for the consignment production as the vaccine is already quite close to commercialization. Due to the government’s settlement with Moderna, a multiple companies may handle the production in South Korea.”
- Company
- Pradaxa and Xarelto to face generic market opening up soon
- by Kim, Jin-Gu Dec 30, 2020 06:03am
- Six South Korean pharmaceutical companies that successfully evaded Pradaxa (dabigatran) and Xarelto’s (rivaroxaban) patents would release generics in advance in July next year. The industry predicts the non-Vitamin K antagonist oral anticoagulants (NOAC) market currently led by the originals would take a sharp turn soon. Moreover, a generic version of dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) would be launched soon with the preferential sales rights. Also, Brilinta (ticagrelor) generic market would be opened late next year with 25 South Korean companies backed by the preferential sales right. ◆ Generic market for Pradaxa and Xarelto to open in July and October next year, respectively On Dec. 28, the Ministry of Food and Drug Safety (MFDS) and the Korean Intellectual Property Office (KIPO) announced the preferential sales rights would be granted on total 37 items from next year. First, four companies that overcame NOAC Pradaxa’s patent are to release their generics early on July 18 next year. Intro Bio Pharma’s Dabican, Aju Pharm’s Dabitran, Jinyang Pharm’s Pradabi and Huon’s Hubitran are the generic by the four companies. The four companies won the patent dispute against the original drug company Boehringer Ingelheim in January 2019. The obtained preferential sales rights are to last until April 2022. Another NOAC, Xarelto is also expecting its generic versions to emerge after Oct. 4 next year. Hanmi Pharmaceutical’s Riroxban and SK Chemical’s SK Rivaroxaban have been preparing for the launch. The wildcard is actually Chong Kun Dang, who challenged Xarelto’s product patent that neither one of the two companies could not overcome. If the court rules in favor of Chong Kun Dang by Oct. 4 next year, the company would be able to market the product even before Hanmi Pharmaceutical and SK Chemical regardless of the preferential sales rights. So far, the NOAC market was predominantly occupied by the original Eliquis, Pradaxa, Xarelto and Lixiana. But, soon the generics would tackle the market with the boost from Xarelto generic. In fact, Eliquis’ patent was challenged the first. In May 2018, Chong Kun Dang and Yuhan Corporation received the preferential sales rights and launched their generics after June 2019. Now the preferential sales period has ended and 12 generic companies are expanding their market share. And in next year, only Lixiana would be the one without generic competitors. Considering Lixiana generic would tap on the market in 2026, the original would dominate the market for a while longer. ◆25 Brilinta generics to rush into the market from November next year An antidiabetic DDP-4 inhibitor developed by Novartis, Galvus is expecting its generic version to be released in advance on Aug. 30 next year Ahn-gook Pharm (including Ahn-gook New Pharm) would exclusively practice the generic preferential sales right. The South Korean company succeeded in nullifying the extended original patent term. But the relevant patent dispute has not been settled completely, yet. As Novartis took the case to a higher court, the Supreme Court would be making the final decision. After Nov. 21 next year, Brilinta’s generics would be released early. About 30 pharmaceutical companies in South Korea challenged AstraZeneca’s antiplatelet drug patent. Ultimately, Chong Kun Dang successfully won 25 claims and received the preferential rights. ◆Preferential sales right period on Betmiga generic ended, nine generic companies ready to take off Meanwhile, some generics’ preferential sales benefit would be terminated soon. On Jan. 8, the benefits on desvenlafaxine generics would be taken away. Its original is Pfizer’s antidepressant Pristiq Extended Release Tablet. Whanin Pharm, Nexpharm Korea, Myung In Pharm and Hanlim Pharm got the preferential sales rights in last April. From Feb. 3, two mirabegron generics would no longer protected by the preferential sales rights. Astellas’ overactive bladder treatment Betmiga is the original. As Hanmi Pharmaceutical and Chong Kun Dang successfully challenged the patent, they respectively released Mirabek and Selebeta. As Betmiga generates around 70 billion won annually, the generic companies would aggressively jump into the market after February when the preferential sales period ends. Currently, nine companies, including Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, Daewoong Pharmaceutical and etc., have evaded the patent and some of them even completed the bioequivalence test and are fully prepared for the launch already.
- Company
- Samsung Bio & Hanmi will participate at JPM 2021
- by Kim, Jin-Gu Dec 30, 2020 06:02am
- At the 38th JPMorgan Healthcare Conference held this year, Kwon Se-chang, President of Hanmi, announces R&D strategies. This 39th event will be held online under the influence of COVID-19 20 domestic pharmaceutical bio companies announced their participation in the JPMorgan Healthcare Conference, which will be held early next year. Among them, Samsung Biologics was the only one to be assigned a main session presentation. Celltrion, who attended every time, declared absence after 10 years. The JPMorgan Healthcare Conference, which marks its 39th year next year, is the largest conference in the bio field where global pharmaceutical companies share new drug R&D achievements and status, and understand trends in the global pharmaceutical industry. This conference will be held online from January 11th to 14th due to COVID-19. ◆Samsung Biologics debuts as new president, John Rim There were about 20 domestic companies that announced their participation in the JPMorgan conference by the 28th. Samsung Biologics is one company that has been assigned the main track. The announcement was scheduled for the morning of the 13th. Although the details of the announcement have not been decided yet, it is attracting attention in that it is the first official stage of the newly appointed John Rim. Hanmi, Hugel, HK inno.N, LG Chem, and Genexine were assigned to announce an auxiliary session (Emerging Market Track). Hanmi is scheduled to announce on the afternoon of the 11th and the rest of the companies on the morning of the 13th. Hanmi has not yet decided on a specific announcement. Last year, they announced HM15211, which is being developed as a treatment for NASH. Hanmi has released three HM15211-related research results in succession this year at the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. The Food and Drug Administration (FDA) has designated this substance as Fast Track. HK inno.N is participating in this event for the first time. HK Innoen plans to introduce autoimmune disease treatment and NASH treatment, including Kcab. Genexine will introduce the business strategy of Continuous Interleukin-7 (GX-17). GX-17 is a substance under development as an anticancer drug for various indications and a treatment for COVID-19. Celltrion, a regular member of JPM conference, decided to absent after 10 years. Celltrion was initially reported to have been assigned to the main track along with Samsung Biologics, but will not attend this event to focus on the development of corona antibody treatment. ◆Bio companies such as Enjikem·Genome & Co have also declared participation Enjikem·Genome & Co·ABL Bio·Crystalgenomics· AptaBio·SCM LifeScience Co Ltd·Cellivery·KoBioLabs·Bioleaders·Eoflow are also planning to participate in this JP Morgan conference. Enjikem introduces EC-18, which is being developed as a treatment for COVID-19, and a treatment for oral mucositis caused by chemoradiation on cancer. Phase II clinical trials for oral mucositis are in the final stage. The company plans to announce the results of Phase II in the first half of next year. Genome & Co plans to discuss technology transfer of pipelines such as new immune checkpoint inhibitors and autism treatments. At last year's JP Morgan conference, discussions on additional co-development of GEN-001, a microbiome-based immune anticancer drug, jointly developed with Merck and Pfizer will also be in progress. ABL Bio plans to focus on its dual antibody platform Grabody-B, which increases the penetration rate of the blood-brain barrier, and ABL301, a Parkinson's disease treatment that introduced it. Crystalgenomics will be presenting the data of Ivaltinostat, CG-745', a new drug candidate for anticancer and antifibrosis treatment. AptaBio introduces the company's core platform technology and pipeline, focusing on the diabetic nephropathy treatment APX-115. APX-115 is undergoing multi-national phase II clinical trials in Europe. Patients started medication for the first time in September, and interim data is expected to be available in the first quarter of next year. Cellivery will announce the efficacy and development status of its immunotherapy iCP-NI as a treatment for COVID-19. In addition, it plans to release data on the efficacy of iCP-Parkin, a dementia treatment drug that utilizes TSDT, a drug substance transmission technology in vivo. KoBioLabs shares the clinical progress of major microbiome new drug pipelines, such as KBLP-001 and KBLP-002, the immune disease tasks that are undergoing global clinical trials. In addition, KBLP-004, a microbiome-derived effective substance-based NASH treatment, plans to explore the possibility of joint research and technology transfer from a preclinical study based on the research results on a new target identified by KoBioLabs. Bioleaders introduces research and clinical programs using Huma MAX and MucoMAX technology, which are self-developed new drug platforms. It is also planning to discuss the licensing of anticancer drugs and Sacopenia candidates as well as clinical trials for cervical intraepithelial neoplasia and Duchenne muscular dystrophy treatments. Expectations and concerns coexist in the pharmaceutical industry over this event, which is held online for the first time in 39 years. While there are concerns that the opportunity for business meetings will decrease, there is also an expectation that more active meetings will be possible because there are no temporal and spatial constraints.
- Company
- Successful year for Korean new drug, biosimilar and test kit
- by An, Kyung-Jin Dec 29, 2020 06:09am
- The year 2020 was a fruitful year for the South Korean companies and their R&D outcomes showcased in the global market. Yuhan Corporation licensed out its novel lung cancer treatment ‘lazertinib’ to Janssen for 100 billion won. SK Biopharmaceutical put the gears in motion for its anti-epileptic drug Xcopri sales in the U.S. market. The previously neglected diagnostic testing kit manufacturers emerged amid COVDI-19 as the success cases of the infectious disease prevention in South Korea. Samsung Bioepis and Celltrion broke the export record with their competitively priced biosimilars. ◆Yuhan’s Lazertinib confirms 100 percent response rate, the milestone pays out 100 billion won A number of new drugs developed by South Korean pharmaceutical companies have been impactful in the global market this year. An image of Yuhan Corporation HQ Yuhan met the development milestone for the novel lung cancer drug lazertinib, licensed to Janssen Biotech two years ago, and received a milestone payment of total USD 10 million paid out in April and November this year. Lazertinib is a third generation epidermal growth factor receptor (EGFR) targeted therapy Yuhan licensed out to Janssen Biotech in November 2018. The Korean company signed the deal with the 50 million-dollar upfront payment and maximum payment of 1.25 billion dollars including clinical, approval and sales milestones. At the ‘European Society for Medical Oncology (ESMO) Virtual Congress 2020’ convened in last September, Janssen presented a Phase Ib interim report on confirming an outstanding response rate in lazertinib combined with amivantamab. 20 non-small cell lung cancer (NSCLC) patients with no previous treatment history, who have either EGFR exon 19 deletion or L858R mutation, have been treated with the lazertinib combination therapy and reached 100 percent objective response rate (ORR) in seven months. Besides lazertinib, Yuhan has also inked five new drug technology license out deals in last two years. When the non-alcoholic steatohepatitis (NASH) treatment candidate, licensed out to Boehringer Ingelheim, completed the non-clinical toxicity test in last April, Yuhan acquired 10 million dollars. Within this year, Yuhan generated total of 77.9 billion won for the license out contracts, which vastly exceeds 57.1 billion won, the operating income accumulated up to third quarter. As the value of licensing out new drug commercialization has gone up, the Korean company successfully overcame the risk of faltering sales with expanded R&D investment. ◆SK’s Xcopri commercialized in the U.S. New drugs developed by SK Biopharmaceutical’s own technology are also seeing some satisfying commercialization outcomes. SK Biopharmaceutical has generated 9.9 billion won as of the third quarter this year. The statistic report found a narcolepsy treatment Sunosi (solriamfetol), licensed out to Jazz Pharmaceutical in 2011, generated 4.6 billion won and a partial-onset seizure treatment Xcopri (cenobamate) generated 5.3 billion won. Although the figure is insignificant compared to last year’s sales 123.6 billion won, making almost 10 billion won from the license out sales was remarkable. Currently, SK Biopharmaceutical has diversified commercialization strategy for Xcopri in respective regions. For the world’s biggest U.S. market, the Korean company’s subsidiary in the region SK LifeScience directly launched the product in last May. Also the company plans to directly handle the Xcopri commercialization in Japan, China and South Korea, but for other regions like Europe, the company plans to seek a local partner. ◆COVID-19 testing kit '99.9 percent for export' Testing kit companies in South Korea had an unexpectedly successful year due to the pandemic. One of the top companies who benefitted from the global pandemic is a molecular testing kit specialist company Seegene. The company’s accumulated operating income up to the third quarter skyrocketed by 24 times from 17.3 billion won last year to 418.7 billion won this year. During the three quarters, the company generated 683.5 billion won of sales revenue, which is more than eight-folds of last year’s. Among all healthcare companies in South Korea, Seegene came in second with the operating income following Celltrion making 245.3 billion won. The operating income against sales revenue marked 64.9 percent. If the sales revenue actually exceeds the company’s projection for this year at 1 trillion won, the company would be making almost ten-folds of last year at 122 billion won. Seegene COVID-19 test kit Seegene had a record breaking performance by proactively developing COVID-19 testing kit to help diagnose the infectious disease in suspected patients during the early stage of COVID-19 outbreak. The company exports the COVID-19 relevant products out to 70 countries. As of the third quarter, the 94.4 percent, or 645.4 billion won, of the overall sales revenue was from the export. Regardless of the swift distribution of COVID-19 vaccine in the U.S. and other countries, the industry projects the worldly demand for the testing kit would remain high for a while. ◆Celltrion and Samsung Bioepis break quarterly revenue Amid COVID-19, South Korea’s top biosimilar companies continued to exceed top export records with successful portfolio. Celltrion (left) and Samsung Bioepis R&D laboratory (Source: respective companies) Celltrion Healthcare easily passed last year’s annual sales revenue at 1.10 trillion won by earning 1.24 trillion won as of the third quarter this year. Celltrion Healthcare sells Celltrion’s biosimilar products to global distributors. Basically, Celltrion Healthcare’s sales revenue indicates Celltrion’s antibody biosimilar export volume. Mabthera’s biosimilar Truxima, prescribed to patients with blood cancer and rheumatoid arthritis, topped the leader board by selling 590.5 billion won as of the third quarter. Celltrion’s U.S. partner Teva reported Truxima’s market share reached 20.4 percent as of September, which was only 11 months after the U.S. market launch. The company also noted the drug is threatening the original’s top position with the drug’s strength of being the first rituximab biosimilar anticancer treatment. Breaking its own top record, Samsung Bioepis’ third quarter sales revenue of 236.9 billion won grew 2.3 percent from last year at 231.6 billion won. Although COVID-19 has slowed down the growth, the company made a new quarterly revenue record in a year as the biosimilar sales in Europe surged. Samsung Bioepis’ European partner Biogen said three biosimilar products combined—Benepali, Flixabi and Imraldi—have earned 27.9 million dollars (approximately 235.7 billion won) in the last third quarter. The Korean company’s Enbrel biosimilar Benepali was the first product to tap on the European market, and it made 124.20 million dollars, jumping 7.2 percent from last year same time.
- Company
- High import drug dependency, Korean drug ratio keeps falling
- by Chon, Seung-Hyun Dec 29, 2020 06:08am
- The dependency on imported pharmaceutical products in the South Korean market seems to be getting higher. The volume of the country’s locally manufactured complete product and active pharmaceutical ingredient (API) has fallen for two consecutive years. The self-sufficiency in API has even halved in just two years. According to the ‘Food and Drug Statistics 2020’ published by the Ministry of Food and Drug Safety (MFDS) on Dec. 25, the production of Korean-made complete drug has increased by 7.0 percent this year, compared to last year, reaching 19.84 trillion won. The complete product import generated 4.77 trillion won, surging 20.0 percent this year compared to 2018, when the import volume was also increased by 13.0 percent hitting 5.25 trillion won. The ratio of complete drug manufacturing self-sufficiency in 2018 was 74.1 percent, which was 1.5 percent lower than the previous year. The self-sufficiency ratio indicates the proportion of the Korean-made products in the overall market. The self-sufficiency ratio in complete product in 2017 reached 77.6 percent, and the figure has been dipping for last two consecutive years and marked the lowest since 2008, when the statistics disclosed for the first time. The ratio in 2008 marked 83.4 percent. The figure fell below 80 percent in 2012 and then it has been slipping down ever since. The industry analyzes the drop in Korean-made complete drug’s local market share would have been affected by the heightened preference on imported drug and disinterest in generics. As an off-patent new drug pricing is brought down to level with generics, the prescribers appear to prefer the originals more than the generics. In South Korea, the original’s reimbursed pricing is reduced to 70 percent of the initial pricing when a generic is released to the market. And the pricing falls again to 53.55 percent of the initial pricing a year after the pricing adjustment. As for generic, the initial upper limit pricing is set at maximum 59 percent of the original pricing before the patent expiration, and it would be reduced down to 53.55 percent the initial pricing after a year like the original. The yearly ratio of Korean-made complete drug in the local market (Unit: percent) Source: MFDS Meanwhile, the dependency on the imported API is rising steeply. South Korea has manufactured 2.47 trillion won worth of API in last year, which was 3.6 percent less than the year before. But API export volume was increased 13.4 percent more than 2018 with 1.98 trillion won, while the import volume was increased 11.6 percent more with 2.53 trillion won. The self-sufficiency ratio in API marked 16.2 percent making over 10 percent point drop. After reaching 35.5 percent in 2017, the figure took a significant fall for two consecutive years. Last year’s API self-sufficiency ratio did not even make it to the halfway point of 35.4 percent recorded in 2017. The pharmaceutical companies evaluate the import volume surged as the Korean manufacturers sought after inexpensive imported API to lessen the production cost. In last year alone, USD 796.96 million worth of Chinese-made API were imported, which was 17.5 percent more than the year before with 678.09 million dollars. Compared to 653.66 million dollars of import in 2017, the volume in last year leaped by 31.6 percent in two years. Meanwhile, the Indian-made API import volume also jumped from 171.89 million dollars in 2017 to 221.14 million dollars last year.
- Company
- Technology exports are active despite COVID-19 outbreak
- by An, Kyung-Jin Dec 28, 2020 06:14am
- The world is struggling with the surprise attack of COVID-19, but domestic pharmaceutical and bio companies' new drug technology export performance is very active. SK Biopharm received the most down payment for the second consecutive year as it transferred the copyright to the Japanese region for a new epilepsy drug developed with its own technology. Yuhan and JW Pharma have made the achievement of transferring new drug technology to overseas pharmaceutical companies for the third consecutive year since 2018. The share of technology exports from bio-ventures with platform technologies such as Alteogen and LegoChem Biosciences has increased significantly. ◆ Bio-venture activities and new drug technology exports are '4 out of 5' Number and scale of technology export contracts for major pharmaceutical bio companies in 2019-2020 (Unit: case, ₩100 million, Source: Financial Supervisory Service, each company) This year, 10 domestic pharmaceutical and bio companies have signed a total of 15 technology export contracts with foreign companies. Compared to last year, when 12 companies won 14 contracts, the number of contracting companies decreased by two, but the number of contracts increased by one. Technology exports are estimated to be ₩10 trillion, up 19.4% from last year. The driving force behind the breakthrough of ₩10.15 trillion in technology exports is bio-ventures, while the world is in a chaotic state due to COVID-19 outbreak. In April, LegoChem Biosciences signed a contract with Iksuda Therapeutics in the UK to transfer the original technology of antibody-drug complex (ADC) worth About ₩496.3 billion. ADC (Antibody-Drug Conjugates) is a technology that enhances therapeutic effect by accurately delivering drugs bound to antibodies to antigens. A total of five contracts signed by LegoChem Biosciences for a year using original technology. In May, the company passed an ADC-based anticancer drug to Iksuda and won an additional contract worth $227 million, and in October, it signed a technology export contract with CStone Pharmaceuticals in China for up to $363.5 million for ADC anticancer drugs. In December, it signed a technology export contract with Pyxis Oncology in the US and two pharmaceutical companies in Japan, respectively, related to ADC anticancer drugs. In the case of transferring the copyright of three ADC-based anticancer drugs to Takeda subsidiary Millennium Pharmaceuticals in March last year, it means that six contracts were signed with the same technology. In addition to LegoChem Biosciences, relatively small-scale bio-ventures showed outstanding technology export performance. 12 out of 15 new drug technology transfer contracts signed by domestic companies this year are achievements made by 7 bio companies including LegoChem, Futurechem, Alteogen, OliX, Voronoi, Genexin, and SK Biopharm. Alteogen received $16 million as a down payment when it passed the right to use the source technology for Hybrozyme to 10 global pharmaceutical companies in June. The technical fee for each stage according to clinical development, marketing authorization, and sales performance amounts to a total of $3.8 billion. Alteogen's original technology for Hyaluronidase is a technology that enables large amounts of subcutaneous administration of all biologics administered intravenously. By taking advantage of the scalability of the original technology that can be applied to various new drug development processes, it achieved an additional contract conclusion in 7 months following last November. Futurechem signed a contract for a total of €1.22 million with IASON GmbH in Austria in May for the diagnosis of prostate cancer, followed by a technology transfer contract worth about ₩650 billion with HTA in China in September. In addition, it is counted that OliX, Voronoi, and Genexine have been handed over. ◆SK Biopharmaceuticals No. 1 in contract payments, JW's outstanding global technology export for 3 consecutive years Among the technology transfer contracts signed this year, SK Biopharm's epilepsy treatment Xcopri (Cenobamate) received the largest down payment. SK Biopharm secured approximately ₩54.5 billion in deposit without obligation to return when it signed a technology transfer contract with Ono Pharm. The milestone according to the achievement of permission and commercialization is up to about ₩524.3 billion. After commercialization, sales royalties of 10% or more were guaranteed. SK Biopharm secured a down payment of ₩54.5 billion this year, the eighth largest of the domestic pharmaceutical industry. SK Biopharm also signed a total of $530 million worth of Xcopri contracts with Swiss Arvelle Therapeutics last year. The down payment secured at the time was $100 million, which is the third largest in history. It has maintained the No. 1 position in technology export contract payments for two years in a row by being recognized for the value of being approved by the US Food and Drug Administration (FDA) as first-in-class with a new mechanism. The size of the upfront of major pharmaceutical bio companies that signed a technology export contract in 2020 (Unit: ₩100 million, Source: Financial Supervisory Service) JW Holdings' nutrient solution technology export contract was the highest in the proportion of the total amount of technology exports. It has signed a technology export and supply contract for Winuf, a comprehensive nutrient solution, with Shandong Luoxin Pharmaceutical, a subsidiary of Luoxin Pharmaceutical in China. The total down payment is $39 million. The down payment without obligation to return is $5 million, which accounts for 12.8% of the total down payment. Winuf is a three-chamber comprehensive nutrient solution that can be easily mixed and used with three ingredients such as lipid, glucose and amino acids by dividing one container into three. It is composed of four lipid components, such as refined fish oil (20%), refined soybean oil (30%), olive oil (25%), and MCT (25%), as well as glucose and amino acids. It is known that it contains a higher content of refined fish oil than existing products, so it contains more omega 3 and omega 6 fatty acids that promote the improvement and recovery of patients' immunity. Previously, there was no case of commercialization of a third-generation comprehensive nutrient solution containing refined fish oil in China, and JW Life Science signed a high-purity contract with a high proportion of down payments as it was recognized for the distinction that JW Life Sciences is in charge of producing finished products after Winuf in China. It is an evaluation that it was possible. It has signed a global technology export contract for 3 consecutive years, starting with the technology transfer contract for atopic dermatitis new drug with Leo Pharma in 2018. ◆SK Biopharmaceuticals No. 1 in contract payments, JW Group's outstanding global technology export for 3 consecutive years The technology transfer contract between Hanmi and Yuhan is also a meaningful R&D achievement this year. Hanmi transferred the GLP-1-based dual agonist returned from Janssen back to MSD within one year. It is a dual-acting treatment that simultaneously activates GLP-1, which helps secretion of insulin and suppresses appetite, and glucagon, which increases energy metabolism, and the original technology of Hanmi Pharmaceutical's LAPSCOVERY, which increases the duration of the drug, was applied. The contract fee, which is not obligated to return, is $10 million, and the maximum contract size, including staged technical fees (milestone), is $870 million. It was positively evaluated for discovering new potential in the field of non-alcoholic steatohepatitis (NASH) instead of diabetes and obesity, which were the existing indications, leading to a new contract. Yuhan made a turning point by handing over gastrointestinal disease treatment candidates, which had been pending for nearly two years, to a small overseas bio-venture without obtaining satisfactory results in the domestic II clinical trial. Yuhan received $2 million of Procesa shares as a down payment by handing over the global copyright of the new functional gastrointestinal disease drug YH12852 to Processa Pharmaceuticals. The maximum contract size, including staged technology fee (milestone), is up to $410.5 million. After commercialization, it was agreed to receive a certain percentage of net sales as royalties. Processa Pharmaceuticals, a partner, will be listed on Nasdaq after the signing of the contract, and is looking forward to further development, saying that it will pursue a phase II clinical trial in the US early next year. Technology export status of major pharmaceutical bio companies in 2020 (Source: Financial Supervisory Service, each company) However, except for SK Biopharm and JW Pharma, the share of down payments in the total amount of technology exports was only 3%. While the overall contract size increased, the proportion of down payments decreased relatively as option contracts and comprehensive platform technology contracts for which the inflow of subsequent milestones was uncertain.
