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- 2025-12-25 08:27:05
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- Why Vemlidy's patent dispute took 3 years to win the 1st tri
- by Kim, Jin-Gu Mar 24, 2022 05:54am
- Generics, which challenged the patent of Gilead Science's hepatitis B treatment Vemlidy (Tenofovir Alafenamide HemiFumarate), won the first trial in about three years. According to the pharmaceutical industry on the 21st, Intellectual Property recently made a "claim establishment" trial on the passive scope of the Vemliddy salt patent filed by Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang against Gilead. The patent expires in August 2032. Pharmaceutical companies that won the first trial have been qualified to release generic products after September, when Vemlidy's PMS period expires. Attention is drawn to this by the referee. Dong-A ST and others requested a trial in December 2018. It took more than three years for the decision to be reached. Generics usually apply for a "priority trial" at the same time when requesting a trial, so it is unusual for the decision to take three years. ◆The conclusion was reached 3 years after the request for trial The pharmaceutical industry explains that Vemlidy's remaining PMS expiration period had a decisive impact on the prolonged dispute. Vemlidy's PMS expires on September 12. As of December 2018, when generics requested a trial, Vemlidy's PMS expiration date was about three years and nine months away. However, Intellectual Property did not immediately look into the incident. This is due to Intellectual Property's regulations on preferential trials. Article 31 of the Administrative Rules of Intellectual Property's "Patent Trial Handling" stipulates that the claimant's application for a priority trial must be judged before other cases.This regulation stipulates that "the trial case for patent rights related to drugs whose expiration date of the retrial period is one year after the date of application for priority trial is excluded." When generics filed a patent trial in 2018, Vemlidy's PMS did not expire within a year, so it was excluded from the priority trial, and only recently, when the PMS expiration date was within a year. An official from the pharmaceutical industry explained, "With the implementation of the patent-approval linkage system, there have been more requests for patent trials by generics to accept generic for exclusivity, and I understand that Intellectual Property has set these regulations to prioritize." He said, "Under this regulation, hearings have not been conducted for a while since the request for a trial, but only recently have the Patent Tribunal begun to look into the case," adding, "The rest of the Vemlidy salt patents that have yet to be concluded are expected to come out soon." Vemliddy is another hepatitis B drug from Gilead, generic for Viread. The active ingredient is Tenofovir Disoproxil Fumarate, but Gilead has newly developed the drug in pro-drug form. This improved drug resistance and kidney toxicity side effects. Vemlidy is rapidly replacing existing Viread in the hepatitis B treatment market. According to IQVIA, pharmaceutical market research firm, Vemlidy's sales surged in four years from 500 million won in 2017 to 28 billion won last year, the first year of its launch. During the same period, Viread's sales fell nearly half from 129.3 billion won to 63.1 billion won.
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- Samsung Bioepis makes ₩847 billion expanding overseas
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- Samsung Bioepis made a new sales record last year. With the global expansion of its biosimilars well on track, the company had made over ₩800 billion last year. According to the Korea Financial Supervisory Service, Samsung Bioepis’s sales recorded ₩847 billion last year, a 9.0% increase from the previous year. This is the largest record ever since the company was established in 2012. Sales have increased 129.7% in just 3 years from ₩368.7 billion in 2018, and have been breaking its sales record ever since. Annual Sales of Samsung Bioepis (Unit: million won, Data: Financial Supervisory Service) After recording ₩765.9 billion in sales in 2019, the company’s growth rate had fallen to 1.5% the next year. The reduced growth has been due to the temporary market contraction that occurred in the early stages of the COVID-19 crisis. The company’s quarterly performance had then showed ups and downs with preorders from hospitals and wholesalers in Europe to secure a supply. However, the company’s recovered growth last year was driven by the increased sales of biosimilars in the US and Europe. Samsung Bioepis’ sales are mostly generated by overseas sales of biosimilars that were developed by the company. Samsung Bioepis had succeeded in commercializing biosimilars of 6 products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All 6 products were approved in Europe, and 5 products less the Avastin biosimilar achieved marketing authorization in the US. The five biosimilars from the company had recorded $1,255,100,000 (approx. ₩1.5 trillion) in overseas sales last year. This is an 11% increase and a new record from the $1,125,800,000 it made in 2020. Samsung Bioepis’ biosimilar is sold abroad by its partners Biogen and Organon. Biogen sells the company’s biosimilars of Enbrel, Remicade, Humira for autoimmune diseases in Europe. Organon sells the mentioned products in countries other than Europe and Korea, and the Remicade biosimilar in the US. Organon is also in charge of overseas sales of Samsung’s two anticancer drugs, the biosimilars of Herceptin and Avastin. Last year, Biogen’s sales of Samsung Bioepis’ biosimilars recorded $831,100,000 (approx. ₩1 trillion), which was a 4% increase from the previous year. Organon’s sales of Bioepis’ products also increased 28% from the previous year to record $424,000,000 (approx. ₩500 billion). Also, the approval of the biosimilars abroad has added new milestones. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and the U.S. Food and Drug Administration (FDA) a month later. Samsung Bioepis will be converted into a wholly-owned subsidiary of Samsung Biologics. At the time of its establishment, Samsung Bioepis was established as a joint venture between Samsung Biologics and Biogen. Samsung Bioepis was launched in February 2012 with a capital of ₩164.7 billion, and Biogen initially invested 15% of the capital, 24.7 billion won. With Biogen only partially participating in the paid-in capital increase, its share fell to 5.4% in 2017. In 2018, Biogen had exercised its call option over Samsung Epis and increased its shares to 50%. Previously, the company had signed a call option agreement under which the company may acquire ‘50% less 1 share’ of Bioepis’s stock by June 29th, 2018. And upon the date of expiry, Biogen decided to acquire the stocks. In June 2018, the company acquired 9,226,068 of the 19,567,921 shares of Bioepis that were owned by Samsung Biologics for $700 million (₩748.6 billion). In January, Samsung Biologics decided to acquire 10,341,852 shares (50% stake) of Samsung Bioepis that was owned by Biogen for ₩2.765 trillion. Samsung Biologics plans to pay the remaining amount of the acquisition price in installments over the next two years. After the acquisition, Samsung Biologics will own 100% of Samsung Bioepis’s shares.
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- Gov purchased ₩200 billion worth of COVID-19 vaccines
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- The COVID-19 vaccine, which incorporates technology from domestic bio companies, will be supplied for the first time in Korea. SK Bioscience announced on the 21st that it has signed a pre-purchase contract with the KDCA for the COVID-19 vaccine worth 200 billion won. The contract volume is 10 million inoculations, and SK Bioscience will sequentially supply the amount according to the Korea Centers for Disease Control and Prevention's inoculation plan when the development of GBP510 is completed. GBP510 is a candidate substance for the COVID-19 vaccine jointly developed by SK Bioscience with IPD. GSK's immune-enhancing technology was also used. Phase 3 clinical trials are currently underway. SK Bioscience self-evaluated, "Korea's No. 1 COVID-19 vaccine, which checks the safety and effectiveness of Phase III clinical trials including Koreans, will be supplied in Korea." SK Bioscience independently produces and supplies two of the five major COVID-19 vaccines licensed in advanced countries such as the United States and the EU (AstraZeneca and Novavax) in Korea. SK Bioscience began consignment production of the undiluted and finished product of the COVID-19 vaccine AZD1222 developed by AstraZeneca last year, and this year, it supplied Nuvaxovid, a synthetic antigen-type COVID-19 vaccine with high safety and proven efficacy. GBP510 was selected for the Wave2 project of the international organization CEPI and is undergoing clinical trials with a total development cost of $213.7 million. In the first half of this year, it is planning to obtain a domestic item license, the WHO emergency license, and the EUA by overseas country. Recently, Rolling Review documents have been submitted to the MHRA for prompt approval. Ahn Jae-yong, president of SK Bioscience, said, GBP510 is the result of SK technology, the government's willingness to leap forward as a biopower, and the cooperation of global organizations supporting vaccine development for public health rights." Starting with GBP510, we will develop products to prepare for various viral infectious diseases and establish ourselves as a leading company in the global vaccine market, he said.
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- Seqirus 'will introduce the first adjuvanted flu vaccine'
- by Mar 22, 2022 05:53am
- A multinational pharmaceutical company has bravely thrown its hat into the domestic influenza vaccine ring that is led by Korean companies such as GC Pharma and SK Bioscience, etc. The company, named Seqirus, is attempting to enter the Korean market equipped with the solid technology it accumulated through its sole focus on influenza vaccines. Seqirus is a vaccine company specializing in influenza vaccines that became the company it is after the influenza department of the Australia-based pharmaceutical company CSL acquired Novartis’s influenza vaccine business. The company has pursued vaccines, only influenza vaccines for over a century, and is known for its extensive influenza vaccine portfolio that covers a wide range of egg-based, cell culture-based, and adjuvanted vaccines. Its annual sales amount to ₩2 trillion. Seqirus's entrance into the Korean market was prompted by the rise of the COVID-19 pandemic after the sole manufacturer of cell-based vaccines in Korea, SK Bioscience, was unable to manufacture its influenza vaccines due to its manufacture of consigned COVID-19 vaccines. Thus, the Korean government granted emergency use authorization for Seqirus's cell culture-based flu vaccine ‘Flucelvax’ in Korea. Also, using the opportunity as momentum, Seqirus made the decision to start the direct supply of its egg-based Afluria that had been marketed through Boryung Biopharma until then. During an interview with Dailpharm, Jonathan Anderson, Medical Head of the International Region of Seqirus, said, “Although there are many excellent companies in Korea that already focus on the development and manufacture of influenza vaccines, Seqirus has strengths of owning various platforms in the area. As a research-based company, we are developing technology for cell culture-based vaccines, adjuvanted vaccines, and self-amplifying mRNA vaccines.” [Interview] Jonathan Anderson Medical Head of the International Region of Seqirus Among its various products, Seqirus has high expectations for its adjuvanted influenza vaccine ‘Fluad’ General flu vaccines can be less effective in immunocompromised elderly, or when the vaccine strain does not coincide with the epidemic, or due to egg-adaptations, etc. In such cases, adjuvanted flu vaccines can improve immune reaction and increase prevention. The ‘MF59’ used in Fluad is an adjuvant that had also been used in 2009 during the swine flu. ‘MF59’ is made using squalene that is produced in the liver, which induces an immune response in the injection site and promotes antigen uptake to increase immune response by activating T cells and B cells. In other words, the adjuvanted vaccine can achieve a strong antibody response even with a small amount. Anderson said, “Real-world results showed that the adjuvanted vaccine showed a better effect in elderly patients over the age of 65.” He added, “Many still get infected with influenza during the influenza season and progress to hospitalization or even death. With the social burden still high for influenza, adjuvanted vaccines could rise as a new alternative.” Anderson added that in terms of safety, the adjuvanted vaccine showed a higher rate of local reactions such as injection site pain than general vaccines, but the reactions were mostly mild or moderate and were resolved naturally over time. Based on its efficacy and safety data, Fluad was approved in 2020 in the US as the world’s first adjuvanted influenza vaccine allowed for use in people aged 65 years or older. Seqirus’s Korea, the Korean subsidiary of Seqirus is working to speed up the introduction of Fluad in Korea. As no adjuvanted flu vaccine exists in the Korean market yet, Fluad's approval by the MFDS is expected to change the domestic flu vaccine market. As Fluad has been introduced to Korea in the past, no separate clinical trial will be required for its introduction to Korea. Anderson said, “Seqirus plans to promptly introduce its vaccine portfolio to Korea. We will make the most effort to fully explain our data through close discussions with the healthcare authorities.
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- GSK’s immuno-oncology drug Jemperli applies for approval
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Another immuno-oncology drug is set to soon be introduced to Korea. According to industry sources, GSK Korea has applied for the approval of its PD-1 inhibitor ‘Jemperli (dostarlimab),’ and is undergoing discussions with relevant authorities. If approved, Jemperli will become the third PD-1 inhibitor to be approved in Korea after ‘Opdivo (nivolumab),’ and ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that started as a melanoma treatment, Jemperli was approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen by the FDA in April last year. In addition, Jemperli was additionally approved for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors in August of the same year. GSK plans to continue adding indications to endometrial cancer in Korea as well. Meanwhile, Jemperli demonstrated its efficacy through the multi-cohort GARNET trial that enrolled patients with dMMR recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum-containing regimen. In the trial, treatment with Jemperli resulted in an objective response rate (ORR) of 43.5%) and a disease control rate of 55.6%. The median duration of response (DoR) had not been reached in these patients, and the probability of maintaining response at six months and 12 months was 97.9% and 90.9%, respectively.
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- Esophageal cancer, added to indication of Opdivo·Keytruda
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Cancer immunotherapys are advancing into the esophageal cancer area one after another. According to related industries, Opdivo (Nivolumab) and MSD's Keytruda recently were added esophageal cancer indications in Korea. Opdivo obtained final approval from the MFDS last month and Keytruda on the 7th. With this permission, Opdivo can be prescribed as an auxiliary therapy for adult esophageal or GEJ cancer patients with residual pathological diseases after CRT. The efficacy of this drug against esophageal cancer was confirmed through a phase III clinical CheckMate-577 study. As a result of the study, the median PFS period for patients treated with Opdivo after surgery was 22.4 months, twice as long as 11 months for placebo-treated patients. The median treatment period of the Opdivo treatment group was 10.1 months, and the placebo group recorded 9 months. Keytruda is the primary combination therapy. This drug can be prescribed in combination with platinum-based anticancer drugs in the primary of non-removable local progressive or metastatic esophageal cancer and gastroesophageal junction cancer. The effectiveness of Keytruda in esophageal cancer was demonstrated through a phase 3 clinical KEYNOTE-590 study. The combination therapy of Keytruda and 5-FU+Cisplatin demonstrated statistically significant OS and PFS improvements over 5-FU+Cisplatin in all pre-designated study groups. Combination therapy with Keytruda, 5-FU, and Cisplatin reduced the risk of death by about 27% compared to 5-FU+Cisplatin, and the risk of disease progression or death by about 35%. It was analyzed that Keytruda, 5-FU, and Cisplatin reduced the risk of death by 38% and the risk of disease progression or death by 49% compared to 5-FU+Cisplatin in the patient group with PD-L1 expression rate of 10 or higher. Meanwhile, Keytruda recently listed primary lung cancer therapy on the insurance benefit list. Opdivo has recently slowed the expansion of gastric cancer benefits, but has not passed the Cancer Disease Review Committee.
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- Celltrion was fined 13.9 billion won
- by Kim, Jin-Gu Mar 22, 2022 05:53am
- Financial authorities imposed a fine of 13.9 billion won on three Celltrion companies that prepared and disclosed financial statements in violation of accounting standards. The Financial Services Commission held its fifth regular meeting on the 16th and decided on this. The fines decided at the meeting are 6 billion won for Celltrion, 6.04 billion won for Celltrion Healthcare, and 992.1 million won for Celltrion Pharmaceutical. Fines of 415 million won were imposed on two people, including Celltrion CEO, and 483.9 million won on three people, including Celltrion Healthcare CEO, respectively. Penalties imposed on the three Celltrion companies and company managers totaled 13.93 billion won. An accounting firm that was judged to have neglected the audit process was also fined. 1.065 billion won was imposed on EY accounting firms and 410 million won on KPMG. Earlier on the 11th, Securities & Futures Commission under the Financial Supervisory Commission decided on measures such as recommending the dismissal of executives in charge and designating auditors for serious violations in the accounting process of the three Celltrion companies. According to the results of the investigation and supervision, these companies committed violations such as overestimating development costs, sales, and inventory assets, or not listing transaction notes with related parties in their financial statements. The Securities & Futures Commission has decided not to file a complaint with the prosecution, saying it is difficult to say that the violation was intentional. Accordingly, Celltrion was not subject to the Korea Exchange's transaction suspension.
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- Concerns over fungal infection due to COVID-19
- by Eo, Yun-Ho Mar 21, 2022 05:56am
- There is concern about the gap in fungal infections due to the re-proliferation of COVID-19. The most commonly reported fungal infections in COVID-19 patients include COVID-19 associated pulmonic aspergillosis (CAPA), COVID-19 associated mucomycosis (CAM), and Candida auris. These COVID-19-related fungal infections can lead to serious diseases and deaths. If left untreated, CAPA-related morbidity reaches up to 80%, and CAM mortality is close to 100%. CAPA is a secondary fungal infection mentioned as a clinical complication of COVID-19 infection in the government's COVID-19 response guidelines, and CAPA has been confirmed in Korea. ◆The number of patients who need antifungal drugs in Korea also surged According to the KSID Autumn Conference presentation data in November last year, 57.8% (126/218) of 218 patients with severe COVID-19 were treated by ICU, and the cumulative incidence rate of CAPA related to COVID-19 was 4.5% (10/218) and 11.2% (10/89) of COVID-19 patients admitted to intensive care units. In-hospital mobility was 11.9% (26/218) in COVID-19 patients and overall mobility in CAPA patients was 50% (5/10). It was found that CAPA secondary infection affected the survival of COVID-19 patients. COVID-19-related CAPA mainly occurs in severe COVID-19 patients who use ventilators in intensive care units, and patients often show non-specific symptoms, and it is difficult to diagnose because samples need to be collected deep in the lungs. Choo Eun-joo (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University) said, "As experienced through the COVID-19 pandemic, it is important to preemptively secure drugs necessary for treating acute infectious diseases at the government level. New antimicrobial and antifungal drugs, which are essential for treating infectious diseases, are having difficulties in development around the world despite high clinical needs," she said. Surgical surgery and antifungal agents including Amphotericin B, Posaconazole or Isavuconazole can be used for COVID-19-related CAM treatment, and Voriconazole is not recommended for CAM treatment. Posaconazole has indication for the treatment of CAPA patients in Korea, so if CAPA or CAM is suspected in COVID-19 patients, Cresemba (Isavuconazole) is the only drug that can be used preemptively at the same time as fungal culture. Cresemba is an antifungal agent that has indications for both invasive CAPA and invasive CAM. Cresemba was designated as a national essential drug in June 2021. This drug is licensed and used in March and October 2015, respectively, in the United States and Europe (EMA), but it is not reimbursed in Korea. Professor Choo said, "In Korea, new antibiotics are allowed, but insurance benefits have not yet been registered. There are no antibacterial and antifungal drugs that have entered the right to benefit for the past five to seven years. Drugs necessary to treat fatal infectious diseases should not be evaluated only from an economic perspective, as they play a key role in preventing the spread of infectious diseases as well as the survival of individual patients."
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- 5 companies challenge breast cancer drug Ibrance’s patent
- by Kim, Jin-Gu Mar 21, 2022 05:55am
- Pic. of Ibrance The number of companies challenging the patent of Pfizer’s breast cancer treatment ‘Ibrance (palbociclib)’ has increased to 5. According to the pharmaceutical industry, Boryung Pharmaceutical, Shinpoong Pharm, Daewoong Pharmaceutical, and Samyang Holdings had filed a series of claims to confirm the passive scope of rights on Ibrance’s crystalline form patent. Kwang Dong Pharmaceutical had been the first to challenge the patent on the 3rd of this month. With the additions, a total of 5 companies will be attempting to avoid the crystalline form patent of Ibrance. In the case of Kwang Dong Pharmaceutical, the company had also received approval for a bioequivalence test to develop a generic version of Ibrance. Ibrance’s crystalline form patent will expire on February 8th, 2034. If the companies succeed in avoiding the patent, they will be able to release a generic version after the drug’s substance patent expires on March 22nd, 2027. The substance patent was originally set to expire on January 10th, 2023, but Pfizer had extended the duration of the patent by over 4 years for the time taken on clinical trials and permits. If generic companies additionally challenge to invalidate the extended term of the patent, it is possible that the date of release of the generic products may be further advanced. Until now, generic companies have not aggressively pursued patents challenges for anticancer drugs as the chances of success of the generic is not high due to the high preference of original drugs in the field. Therefore, the development and release of generics after overcoming the patents was not profitable for the companies. Despite the barriers, the reason why so many companies are challenging Ibrance’s patent is because of the reputation built by the drug in the breast cancer treatment market. According to the market research institution IQVIA, Ibrance has continued to expand by double-digit sales every year since it was approved in Korea in August 2016. In fact, Ibrance's sales, which recorded ₩6.6 billion in 2017, then to ₩25.3 billion in 2018, ₩43.7 billion in 2019, ₩57.3 billion in 2020, and to ₩65.6 billion in 2021. Also, the fact that domestic companies started to make an impact in the generic market for anticancer drugs, which had been considered impenetrable, can also be a reason for the increased challenges filed against Ibrance. Recently, Hanmi Pharmaceutical, Samyang Holdings, Boryung Pharmaceutical, and Chong Kun Dang had been showing significant performance in the market. Hanmi had released its generic version of Bayer’s liver cancer treatment Nexavar, ‘soranib,’ Samyang released BMS’s Taxol generic ‘Genexol,’ Chong Kun Dang released generic version of AstraZeneca’s lung cancer treatment Iressa, ‘Iretinib' to chase the market occupied by original drugs.
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- K-Bio has become a global production hub
- by Kim, Jin-Gu Mar 18, 2022 05:55am
- The Korean pharmaceutical bio industry has become a global coronavirus vaccine and treatment consignment production hub. With the consignment production of coronavirus vaccines and antibody treatments in charge, the company will be in charge of consignment production of oral treatments for the supply of underdeveloped countries. On the 17th, the MOHW announced that Celltrion and DongbangFTL were selected as generic producers of the oral corona treatment Paxlovid developed by Pfizer. Celltrion produces finished products and DongbangFTL produces Nirmatrelvir. The products produced here are supplied to 95 underdeveloped countries. MPP, along with two Korean companies, selected a total of 35 companies from 12 countries around the world. There are 19 in India, 5 in China, 1 in Bangladesh, Vietnam, Brazil, Dominican Republic, Mexico, Jordan, Israel, Serbia and Pakistan. In January, International Pharmaceutical Patent Pool also selected three Korean companies as generics of the oral coronavirus treatment developed by MSD. Hanmi Pharmaceutical was selected along with Celltrion and DongbangFTL. Ildong Pharmaceutical is jointly developing another oral treatment candidate material "S-717622" with Shionogi of Japan. Ildong Pharmaceutical plans to produce oral treatments with Shionogi and supply them globally as soon as the clinical trial is completed. It is interpreted that the stable production capacity of Korean companies has been verified by the world over the fact that they have been selected as a producer of oral treatments one after another. Korean pharmaceutical companies are being used as consignment production bases for COVID-19 vaccines and antibody treatments by multinational pharmaceutical companies. In the case of COVID-19 vaccines, five domestic companies have decided to commission production of five global vaccines. SK Bioscience has been producing AstraZeneca and Novavax vacine since last year. Samsung Biologics has signed a contract with Moderna and is producing a coronavirus vaccine. Although it has not yet begun full-scale supply, the Korus Pharm consortium can commission Russian vaccine Sputnik V, while Hanmi Pharmaceutical and Enzychem can commission ZyCoV-D developed by Indian pharmaceutical company Zydus Cadila. In addition, Samsung Biologics is commissioned to produce AstraZeneca Evusheld and Eli Lilly's Bamlanivimab, which are corona antibody treatments. Celltrion has produced and is supplying its own antibody treatment drug Regkirona globally. At the end of last year, it was approved for use in Europe. An official from the pharmaceutical industry said, "Korea has large-scale facilities for consignment production and has high reliability in quality. With the Corona incident, the status of the Korean pharmaceutical bio industry will increase, and the value of the K-bio brand will also increase on the global stage in the future."
