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Company
K-pharma·biopharmas make great tech export deals this year
by
Chon, Seung-Hyun
Dec 30, 2021 05:51am
Once again, Korean pharmaceutical and biopharmaceutical companies have made great technology export performance this year. Although no mega-deals that amount to top 10 licensing deals were made, technology exports were made in various areas in the industry. Also, performance biopharmaceutical companies stood out this year compared to traditional pharmaceutical companies. According to the Financial Supervisory Service and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association on the 27th, various companies including SK Biopharm, Genexine, AprilBio, Hanmi Pharmaceutical, DongA ST, Alteogen, Olix, Curacle, Daewoong Pharmaceuticals, Bio-Pharm Solutions, Voronoi, D&D Pharmatech, Peptron, KoBiolabs, HK inno.N, Handok, CMG Pharma, LegoChemBio, have inked new drug technology export deals this year. Among the companies, SK Biopharm secured the most - $40 million- in upfront payment with two technology export contracts. SK Biopharm licensed out six central nervous systems (CNS) drugs including ‘cenobamate’ to Ignis Therapeutics. For the deal, SK Biopharm received an upfront payment of $20 million and will be receiving milestone payments of $15 million and royalties on net sales in the future. Also, the Korean drug company acquired 150 million shares of Ignis (share amounts to 44.9% including common stock) through the technology export. Ignis Therapeutics was established by SK Biopharm with Shanghai-based 6 Dimensions Capital (6D). The two companies raised $180 million in investment to establish Ignis , which was the largest Series A investment in the Chinese pharmaceutical industry this year. SK Biopharm signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the contract, SK Biopharm received an upfront payment of $20 million. In terms of single technology export, the largest deal this year was made by Genexine with an Indonesian company with an upfront payment of $27 million. Genexine signed a technology transfer agreement with Kalbe Farma’s subsidiary KGBio for its immuno-oncology candidate GX-I7 (Efineptakin Alpha). Also, the technology export performance of bio-ventures was prominent this year. In October, the non-listed domestic bio company AprilBio had received a one-time payment of $16 million from a Denmark pharmaceutical company Lundbeck under an agreement for the technology transfer of its autoimmune disease treatment candidate ‘APB-A1. Also, Lundbeck will pay AprilBio success-based development, regulatory, and sales milestone payments of up to $432 million related to APB-A1. In addition, Lundbeck also secured $3.6 million to produce study samples for its Phase I clinical trial. In January, GC Lab Cell’s US affiliate had signed an agreement to jointly develop three chimeric antigen receptor (CAR)-NK cell therapies with the US company MSD. Artiva Biotherapeutics, GC Lab Cell’s US affiliate, was established by GC Lab Cell in the US to develop NK cell therapies, and the agreement is expected to be worth up to $1.86 billion. In March, ImmuneOncia Therapeutics, Inc., a US joint venture of Yuhan Corp, signed a deal with the Chinese immune-oncology development company 3D Medicines for the technology transfer of its new anticancer drug candidate IMC-002. Under the contract, ImmuneOncia will grant 3D Medicines exclusive license for IMC-002 in Greater China (including Hong Kong, Macau, and Taiwan). LegoChem Biosciences announced last month that it had signed an agreement to license out its antibody-drug conjugate (ADC) technology to the European company Sotio Biotech. At the time, the company signed an agreement to receive $29.5 million as upfront payment and short-term milestones payment. LegoChem Biosciences had also received $50 million in upfront payment and short-term milestone payments by signing a joint development and technology transfer deal for its ADC anticancer candidate with the UK company Iksuda Therapeutics on the 27th. Other companies including Alteogen, Olix, Curacle, Daewoong Pharmaceuticals, Bio-Pharm Solutions, Voronoi, D&D Pharmatech, Peptron, and KoBiolabs also secured over 1 million in technology export deals this year. Among traditional pharmaceutical companies, Hanmi Pharmaceutical, DongA ST, HK inno.N, and Daewoong Pharmaceuticals also signed tech export deals this year. Hanmi Pharmaceutical signed a technology export deal with Aptose Biosciences for its innovative new drug for acute myeloid leukemia(AML), the FLT3 inhibitor ‘HM43239.’ Dong-A ST signed a global license-out agreement with Intas Pharmaceuticals for its Stelara biosimilar DMB-3115 in July under the condition of receiving $10 million upfront in payment with no obligation of return and milestone payments up to $95 million. Daewoong Pharmaceutical signed a tech export and supply deal worth $338 million with Shanghai Haini, a subsidiary of China’s Yangtze River Pharmaceutical Group in March for its gastroesophageal reflux treatment Fexuprazan. The deal includes 6.8 billion won in upfront payment and $20.4 billion in milestone payments which are paid when each phase of a clinical trial is completed. HK inno.N, Handok, and CMG Pharma also received over $1 million in upfront payment for their technology export deals.
Policy
Will Boryung succeed in tackling Sprycel’s patent
by
Lee, Tak-Sun
Dec 30, 2021 05:51am
Whether a generic for the second-generation chronic myeloid leukemia treatment ‘Sprycel (dasatinib, BMS)’ will be introduced following generics for the first-generation ‘Gleevec (imatinib mesylate, Novartis)' is gaining attention. If introduced, Sprycel’s generic is expected to greatly improve patient accessibility. According to the industry on the 28th, Boryung Pharmaceutical is starting to develop a generic for Sprycel. Since 2013 when the first generic Gleevec was introduced to the market, domestic pharmaceutical companies have attempted the development of a generic version of Sprycel. However, the companies were not able to progress due to patents, etc. No approvals nor bioequivalence tests were made for generic Sprycel since its PMS expiry on August 19th, 2016. Some domestic pharmaceutical companies had attempted patent challenges in 2015 but dropped their suits the same year. Sprycel’s substance patent expired last year on April 12th. Attempts at generic Sprycel started again in December last year with Boryung Pharmaceutical filing an invalidation trial and a Passive trial to confirm the scope of the patent on Sprycel’s use patent (expires on March 23rd, 2024) and crystalline form patent (expires on February 4th, 2025). Daewoong also joined in the invalidation trial on Sprycel’s use patent. Boryung Pharmaceutical then applied and received approval for a bioequivalence test protocol on 'BR2009' from the Ministry of Food and Drug Safety. The BR2009 targets chronic myeloid leukemia like Sprycel. Given this, analysts are assuming that the bioequivalence test is for the development of a generic for Sprycel. Boryung Pharmaceutical currently owns a generic version of Gleevec, ‘Glima Tab.’ The company had opened the doors for generic entry by winning the patent invalidation suit for Gleevec’s composition patent. If Boryung Pharmaceutical succeeds in releasing a generic version of the second-generation Sprycel following its success in releasing a generic for the first-generation Gleevec, the company’s status and competitivity in the relevant market is expected to further increase. However, it is difficult to predict the success as the company is in the early stages of the patent challenge. Therefore, attention is focused on whether Boryung Pharmaceutical will be able to open the tightly closed latch for generic versions in Sprycel as in Gleevec.
Policy
The MFDS plans to approve Daewoong's Fexuprazan
by
Lee, Tak-Sun
Dec 30, 2021 05:51am
Fexuprazan, a new drug for GERD that Daewoong Pharmaceutical has researched and developed for 14 years, is expected to obtain domestic approval soon. When Fexuprazan is released, Daewoong is expected to fill the gap in the PPI-based treatment Nexium. According to the industry on the 28th, the MFDS completed the safety and effectiveness examination of Fexuprazan and left only the final approval procedure. Fexuprazan applied for an item license to the MFDS in November 2019. Fexuprazan is P-CAB drug such as K-Cab (Tegoprazan, HK inno.N) licensed in July 2018. The advantage of P-CAB-based drugs is that they have a longer gastric acid secretion inhibition effect than conventional PPI-based drugs. Therefore, it is possible to administer regardless of meals. With the launch of K-Cab, the existing PPI-oriented GERD market structure is also changing. K-Cab is expected to achieve 100 billion won in sales this year and has risen to the No. 1 item in the market. Prior to the launch of K-Cab, the No. 1 item in the market was Nexium. Nexium is an imported drug developed by AstraZeneca and has long been sold by Daewoong Pharmaceutical in Korea. AstraZeneca recently terminated its Nexium co-promotion contract with Daewoong Pharmaceutical and chose Ildong Pharmaceutical as a new sales partner. Analysts say that Daewoo's termination of the contract for Nexium, which generates annual sales of 50 billion won, is due to the imminent approval of Fexuprazan. With K-Cab has become the next-generation leader in GERD, so it is predicted that Fexuprazan's launch will quickly resolve the gap in Nexium. If Fexuprazan is approved, it is likely to become the 34th new domestic drug. The MFDS approved two new domestic drugs this year, with No. 32 Leclaza and No. 33 Rolontis (Hanmi Pharmaceutical). If Fexuprazan is approved by the end of this year, three new domestic drugs will be released a year.
Company
Donepezil Patch, which is about to be released
by
Dec 30, 2021 05:51am
Donepezil Celltrion's Donerion Patch, the world's first Donepezil patch, is scheduled to be officially released on the market in the first half of next year. The price of the patch system, which is attached twice a week, is expected to be about 5,000 won per patch. According to the pharmaceutical industry on the 28th, Celltrion Pharmaceutical is collecting hospitals to trade with ahead of the launch of Donerion Patch in the first half of next year. The Donerion Patch comes in two sizes: 87.5 mg/25㎠ and 175 mg/50㎠. If taking oral Donepezil with a dose of 5 mg per day, 87.5 mg/25㎠ can be used, and if taking a dose of 10 mg, 175 mg/50 can be used. The Donerion Patch drug price is expected to be 4,830 won for 87.5 mg/25 and 7,245 won for 175 mg/50. It is used twice a week, so it will be 9,660 won based on 87.5 mg/25 ㎠. In the case of oral Donepezil 5mg, which is taken once a day, it ranges from a minimum of 4,060 won to a maximum of 14,420 won per week. Donerion Patch is the world's first Donepezil patch system developed by Icure and obtained exclusive copyright in Korea by Celltrion. It is an IMD that has been used only for oral purposes due to difficulties in developing formulations and is commercialized as a patch agent that attaches it to the skin. It improved medication compliance and increased convenience for dementia patients who have difficulty taking drugs. Donerion Patch proved the non-equivalence of the treatment effect compared to oral Aricept in a phase 3 clinical trial conducted in patients with mild and moderate Alzheimer's dementia. As of last year, the domestic Donerion market was about 230 billion won, accounting for 80% of the total sales of Alzheimer's dementia treatments. Among them, the original Eisai's Aricept's outpatient prescription amounted to KRW 83.9 billion won. Second place was Ebixa, recording 13.7 billion won.
Company
Patents for representative DM drugs are expected to expire
by
Kim, Jin-Gu
Dec 29, 2021 05:58am
Next year, patents for DPP-4 inhibitor-based diabetes treatments such as Tenelia, Onglyza and Galvus will be released one after another. It is predicted that generic companies will join the domestic DPP-4 inhibitor-affiliated diabetes treatment market, which has grown to 600 billion won a year. In the case of generics for Galvus, more than 10 pharmaceutical companies are expected to release generics after January. More than 30 companies are expected to release generics for Tenelia after October. ◆Ahn-gook and Hanmi will launch generic for Galvus in January, and 12 companies will join in March According to the MFDS on the 28th, there are a total of 159 patents for medicines that expire next year. One or more patents for 79 products are scheduled to expire next year. The pharmaceutical industry's attention is focused on diabetes treatments based on DPP-4 inhibitors. This is because patents for major treatments that have emerged in earnest since the late 2000s will expire one by one from next year. The first product whose patent expires is Novartis' Galvus. On March 4 next year, material patents for Galvus and Galvusmet will expire. According to UBIST, a pharmaceutical market research firm, the total prescription amount of Galvus and Galvusmet reached 44.5 billion won as of last year. At the same time as the patent expires, 14 companies are expected to compete for generics. Among them, Ahn-gook and Ahn-gook newpharm succeeded in invalidating 55 days of the extended duration of material patents by winning the patent dispute between Novartis and the Supreme Court. Ahn-gook and Ahn-gook newpharm received the generic for exclusivity until May 29 next year. Hanmi Pharmaceutical also won the dispute with Novartis, eliminating concerns over patent infringement. Hanmi Pharmaceutical was approved for a single drug only by salt change. It can be sold regardless of Ahn-gook's generic for exclusivity. ◆Material Patent for Tenelia, Expired in October, many generics will be released In the fourth quarter of next year, patents for Tenelia, another DPP-4 inhibitor-based diabetes treatment, and Onglyza and Kombiglyze will expire. Tenelia's material patent expires on October 25. Generics overcame all other patents except material patents. This means that generics can be released immediately when only material patents expire. Generics succeeded in invalidating Tenelia's salt patent in December 2019. Since then, MTPK, the original company, has appealed, but even the patent court has sided with generic companies in September this year. The ruling was then finalized when MTPK gave up its appeal to the Supreme Court. Since the Tenelia patent has been invalidated, companies that are not involved in patent disputes after the expiration of the substance patent in October can also launch generic products. Generic competition is expected to be fiercer than other cases. In Korea, 34 companies have already been approved for related generics. ◆Onglyza patent expires in December In December next year, AstraZeneca's DPP-4 inhibitors, Onglyza and Kombiglyze, will expire. In the case of Onglyza, there are no patents other than material patents. Kombiglyze, a combination drug, had one drug license, but it already expired in March 2019. Generic can be released immediately when the material patents of the two products expire. However, generic's interest in Onglyza and Kombiglyze does not seem to be greater than other drugs. None of the pharmaceutical companies have been approved for related generics yet. It is said that no place is preparing for a related biological equivalence test. The total prescription amount for Onglyza and Komblyze last year was 27.6 billion won.
Company
A reimbursed optn in hormone-sensitive prostate cancer?
by
Eo, Yun-Ho
Dec 29, 2021 05:58am
Whether a treatment option may be added to the hormone-sensitive metastatic prostate cancer treatment environment that lacked options is gaining attention. According to industry officials, Astellas Korea applied for the extended insurance benefit of its anticancer drug ‘Xtandi (enzalutamide)’ in combination with androgen deprivation therapy (ADT). The agenda is expected to be deliberated at the National Health Insurance Service’s Cancer Disease Deliberation Committee meeting in January. The company applied for the indication to treat ‘metastatic hormone-sensitive prostate cancer (mHSCP),’ an area where a great unmet need remains. ADT+docetaxel, a standard therapy option for mHSPC treatment, may not be appropriate for older patients who have various underlying diseases. Also, the use of other treatment options is limited to high-risk mHSPC patients whose disease has progressed significantly. Therefore, the Xtandi+ADT combination is receiving attention for demonstrating its effect in low-risk mHSPC patients that had limited options. Due to the term ‘low-risk,’ low-risk mHSPC patients may seem to be at less risk, but it is a term defining advanced prostate cancer patients with accompanying distant metastasis. In the Phase III ARCHES study that was conducted on 1,150 mHSPC patients, the Xtandi+ADT combo significantly reduced the risk of radiographic progression-free survival (fPFS) by 61% compared to placebo+ADT, regardless of disease volume or degree of metastasis. Xtandi+ADT combo therapy is recommended in various international guidelines for the treatment of mHSPC including the US National Comprehensive Cancer Network (NCCN), European Association of Urology (EAU), American Urological Association (AUA) as well as in the domestic ‘2020 Korean Treatment Guideline for Metastatic Prostate Cancer’ published by Korean Society of Medical Oncology, Korean Cancer Study Group, the Korean Urological Oncology Society, and the Korean Society for Radiation Oncology. Cheol Kwak, Professor of Urology at Seoul National University Hospital, said, “The treatment objective for mHSPC is extending the life of metastatic prostate cancer patients and delaying progression to metastatic castrate-resistant prostate cancer (mCRPC) while maintaining the quality of life for the patients.” He added “Xtandi is a treatment that allows low-risk mHSCP patients with low-volume disease to better manage their disease, including those that are not suitable to use abiraterone or docetaxel due to their underlying disease or condition. We hope that discussions on its reimbursement promptly take place so that more patients can maintain quality of life at a relatively healthy state for a long time.”
Policy
Paxlovid is a new weapon added to our fight against COVID-19
by
Lee, Jeong-Hwan
Dec 29, 2021 05:58am
Minister Gang-lip Kim “An oral-type treatment will be prescribed to patients with severe or critical COVID-19 that are unsuitable to be treated with an injection-type (antiviral). In other words, we have secured another option in our armory to use against COVID-19.” Ministry of Food and Drug Safety Minister Gang-lip Kim This is what Minister Gang-lip Kim of the Ministry of Food and Drug Safety said, explaining that a new viable strategy for the control and management of COVID-19 will be added with the early use authorization of the oral COVID-19 treatment ‘Paxlovid.’ Although it is too early to jump to a conclusion on whether the oral pill has a better effect than the injectable drug, Minister Kim sees that the added option for severe or critical COVID-19 patients can bring a synergetic effect with the national vaccination scheme and social measures and diversify the methods against COVID-19. Kim said the decisive difference between the oral and injectable drugs is in their convenience in storage, distribution, and intake, and that the oral option may be a more appropriate option for patients treated from home. Minister Kim explained so on CBS radio’s ‘Kim Hyun-Jung’s News Show’ on the 28th after the MFDS had granted emergency use authorization for Pfizer’s oral COVID-19 treatment Paxlovid on the 27th. Kim said although Paxlovid cannot be directly compared with the injection-type form of treatment, it is a reassuring ‘weapon’ added to the fight against COVID-19. Therefore, he said it is too soon to call it a game-changer. The oral COVID-19 pill Paxlovid is taken as three tablets at once. More specifically, a set of drugs (two pink pills, one white pill) is taken together orally every 12 hours for five days. Kim said even if Paxlovid is distributed, it would be difficult to purchase Paxlovid other general prescription drugs. The government handles all of the purchased Paxlovid and will coordinate its provision to the patients. “The government plans to first purchase all of the pills then provide them to those in need. The authorities with the Korea Disease Control and Prevention Agency (KDCA) are discussing the best way to distribute and administer the drug in the field.” In addition, Kim said that the oral pill is significantly different in terms of storage, distribution, and administration compared to the injected-type drug that is being used in severe patients. “Subjects eligible for the oral pill are virtually the same as those for injections. The biggest difference is that the injection needs to be administered by another person for an hour. The oral pill may be self-administered with prescription every 12 hours for 5 days, and therefore is appropriate for patients treated at home.” “Also, in terms of storage, the drug can be stored at room temperature. Therefore, the decisive difference between the oral and injectable drug is in its convenience in storage, distribution, and intake.” On the question of whether the injection and oral pill has the same effect, Kim said that the two options cannot be compared horizontally. Rather, the use of oral drugs should be considered as an additional option to the injection already in use, and one more option in the fight against COVID-19. Kim said, “The most difficult question to answer is whether the treatments have the same effect. The treatments had different subjects in clinical trials and we cannot tell whether the drugs have the same effect or which is superior. Paxlovid and the existing injection-type treatment both showed a significant effect on severe and critical COVID-19 patients at analysis. We will be able to provide treatments appropriate for every patient -injection for hospitalized patients and oral pills for those that cannot receive the injections - with the added option. In other words, we have secured another weapon against COVID-19.”
Policy
Gov-National Assembly introduce oral treatment for COVID-19
by
Lee, Jeong-Hwan
Dec 29, 2021 05:57am
First Deputy Director Kwon Deok Cheol of CDSCHQ. As COVID-19 spreads to the Omicron mutation following the delta mutation, and the number of deaths and new confirmed patients increases, the attention of the National Assembly and the government is focusing on treatments.The National Assembly's Health and Welfare Committee is urging the U.S. FDA to preemptively secure domestic antibody treatments that are actively considering introducing COVID-19 oral drugs Poxlovid와 Lagevrio. The quarantine authorities are also expressing their willingness to respond quickly to securing oral drugs because they had difficulty in early vaccinations due to failure to secure vaccine supplies in the early stages of the spread of COVID-19. The Central Disaster and Safety Counters Headquaters announced on the 27th that it has signed a pre-purchase contract for COVID-19 oral medicine for a total of 604,000 people. CDSCHQ's Deputy General Manager Kwon Deok-cheol (Minister of Welfare) explained, "Following the United States, the government is also rapidly proceeding with the oral EUA process," adding, "We will be able to administer COVID-19 treatment as early as the end of January next year." The CDSCHQ is taking procedures for the oral drug EUA of COVID-19. The MFDS has announced that it will hold a "Safety Management and Supply Committee for Medical Products Responding to Public Health Crisis" to decide whether to approve the emergency use of COVID-19 oral drugs. In the case of the United States, approval for use has already been completed. The FDA approved the use of Lagevrio on the 23rd following the EUA approval of the Pfizer's Poxlovid on the 22nd (local time). The National Assembly Welfare Committee is also calling for securing COVID-19 treatments, citing cases in advanced countries. Rep. Kang Ki-yoon pointed out the reality that Korean quarantine authorities focused only on securing oral treatments. Kang's view is that next year's government budget bill could also be insufficient to respond to securing various COVID treatments by arranging only the cost of purchasing oral drugs. In particular, he also questioned the treatment effect of Lagevrio, which the quarantine authorities have started purchasing. He pointed out that unlike Merck's 50% reduction in hospitalization and death rates, FDA submission reports fell sharply due to a 30% reduction. The intention is that various treatments need to be secured as the effectiveness of the COVID-19 oral drug has not yet been clearly proven. Furthermore, through expert opinions, he said that measures should be prepared to diversify the use of antibody treatments such as Regkirona and Xvudy so that patients can be treated customized. Advanced countries such as the United States and Europe are actively purchasing various treatments in preparation for the increasing number of COVID-19 patients due to mutations, Kang said. "The United States, Europe, and Australia have started to secure Xvudy supplies, and Regkirona is also approving conditional permits." "Overseas countries are making efforts to select and secure drugs that are effective for severe coronavirus due to the increase in the number of people infected with Omicron," he said. "Korea should also prioritize securing various treatments considering continuous mutations." Customized treatment is required for each patient, he added.
Company
LegoChem transfers candidate technology to British company
by
Chon, Seung-Hyun
Dec 29, 2021 05:57am
LegoChem Biosciences announced on the 27th that it has signed a technology transfer contract with Iksuda for joint development of a new anti-cancer drug candidate LCB14. The contract is worth up to $1 billion (about 1.2 trillion won). With this contract, LegoChem Biosciences secured $50 million (about 60 billion won) in advance payments and short-term milestones. Milestones according to the development, permission, and commercialization stages are up to $950 million. Iksuda will have the right to develop and commercialize LCB14 globally except for China and Korea. LegoChem Biosciences will jointly conduct clinical trials in the United States with Iksuda in a way that pays part of the initial clinical cost. This contract also includes the conditions of receiving advance payments received by Iksuda and additional Revenue Sharing at a fixed rate for all milestones if third-party technology transfers are made during development. LCB14 is a new anticancer drug developed by LegoChem Biosciences using ADC original technology, and phase 1 clinical trials in China are underway. Iksuda is known to have the world's best ADC development capabilities, including Dr. Robert Lutz, who led the preclinical and early clinical trials of global blockbuster ADC drug Kadcylla. Iksuda CEO David Simpson said, "We will continue to develop valuable treatments by focusing on cancer species with limited treatments and establishing competitive pipelines using partners and self-developed toxin and ADC platforms." Cho Young-rak, vice president of LegoChem Biosciences, said, "We will do our best to strengthen our own clinical development capabilities and quickly develop subsequent ADC programs by actively accepting the highest level of development capabilities and know-how through this U.S. clinical joint progress."
Company
SK Bioscience will complete major facilities in Songdo
by
Chon, Seung-Hyun
Dec 28, 2021 05:51am
SK Bioscience, the third-largest pharmaceutical bio company in market capitalization, will build a new construction in Songdo, Incheon. It will invest 300 billion won by 2024 to build a new factory and laboratory. Along with Samsung Biologics, Celltrion, and Celltrion Healthcare, the first to fourth place in the pharmaceutical bio market will gather in Songdo side by side. ◆SK Bioscience will complete the facility in Songdo in 2024 and invested 300 billion won SK Bioscience announced on the 27th that it has signed a land sale contract with the Incheon Free Economic Zone Authority. The plan calls for the construction of a global R&PD (Research & Process Development) center on a 34,414㎡ site in Sr14 district 7, Songdo-dong, Incheon. Earlier in August, SK Bioscience signed a contract with the Incheon Free Economic Zone Authority to acquire 33 billion won worth of land and buildings. The newly created global R&PD center will house research institutes, factories, and offices for basic research and process development and production in the vaccine and bio sectors. SK Bioscience plans to invest about 300 billion won in business expenses with the aim of completing it in the fourth quarter of 2024. SK Bioscience plans to invest about 200 billion won by 2024 to expand manufacturing facilities for L-House, which has the latest vaccine production facilities such as cell culture, bacterial culture, gene recombination, and protein bonding, and build new platform facilities such as mRNA and next-generation viral vectors. When SK Bioscience moves to Songdo, all the first to fourth largest pharmaceutical bio companies in Korea will be located in Songdo. SK Bioscience, which was listed on the KOSPI market in March, has a market capitalization of 17.978 trillion won, ranking third after Samsung Biologics and Celltrion among pharmaceutical bio companies. Samsung Biologics, a bio-captain, was established based in Songdo in 2011. Samsung Biologics is currently operating three biopharmaceutical plants in Songdo. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant). Celltrion, which ranks second in the market capitalization of pharmaceutical bio companies, is the main player in growing Songdo, Incheon, as a mecca for biopharmaceuticals. Celltrion's market capitalization is 28.1412 trillion won. Founded in 2002, Celltrion operates two factories in Songdo. In 2005, the first factory of 100,000 liters was completed in Songdo, and in 2011, the second factory of 90,000 liters was joined. Celltrion is building a 60,000-liter plant with the aim of completing it in 2023. Celltrion is also planning to build a 20-liter plant. When the fourth plant is completed, a total of 450,000 liters of production facilities will be secured in Korea. Celltrion Healthcare, an affiliate of Celltrion, is also evaluated as a bio company representing Songdo. Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global retailers. Celltrion Healthcare is located with Celltrion in Songdo, Incheon. The market capitalization totaled 13.2084 trillion won. The market capitalization of four companies, Samsung Biologics, Celltrion, SK Bioscience, and Celltrion Healthcare, totaled 117.696 trillion won. These companies are by far one of the best among domestic pharmaceutical bio companies. Among the major pharmaceutical bio companies that handle medicines in the third quarter, only three companies recorded operating profits of more than 100 billion won, including Samsung Biologics, Celltrion, and SK Bioscience. The operating profit ratio of SK Bioscience and Celltrion to sales amounts to 45.5% and 40.9%. Samsung Biologics also recorded a high purity return of 37.1%. Along with Celltrion Healthcare, the average profit margin of the four Songdo bio companies exceeds 30%. Recently, SK Bioscience saw its operating profit rise 175.3% year-on-year to 100.4 billion won in the third quarter and sales rise 123.8% year-on-year to 220.8 billion won. The biggest factor in the surge in performance is the consignment production of the COVID-19 vaccine. SK Bioscience signed a consignment production (CMO) contract with global pharmaceutical company AstraZeneca in July last year to supply COVID-19 vaccines. It is a condition to produce the COVID-19 vaccine under development by AstraZeneca at L House in Andong, Gyeongsangbuk-do. In August last year, the MOHW and Novavax also signed a three-way contract to supply the COVID-19 vaccine NVX-CoV2373 and began production.
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