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- 2026-05-17 00:50:39
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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.
- Company
- 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.
- Company
- 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.
- Company
- 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."
- Product
- Paxlovid shortage to be resolved with Molnupiravir approval?
- by Jung, Heung-Jun Mar 21, 2022 05:55am
- The shortage of Paxlovid at pharmacies is expected to be partially resolved with the government's emergency approval of Merck (MDS)’s oral COVID-19 treatment ‘molnupiravir.’ On the 18th, the Central Disease Control Headquarters had announced that 88,276 courses of Paxlovid remain in stock in Korea. Also, with the grant of RAT(rapid antigen test)-based confirmation of COVID-19, the average daily prescription of Paxlovid increased over twofold from 2,404 in the second week to 5,184 in the third week of this month. With more than 300,000 new confirmed cases occurring steadily, the domestic inventory of Paxlovid is expected to be exhausted by the end of this month. The government is planning to introduce additional courses of Paxlovid in Korea soon, but many base pharmacies are already out of stock and unable to dispense the drug. Pharmacy A at Seoul said, “The amount and period of Paxlovid shipments aren’t constant, but we receive around 100 courses per shipment, and this doesn’t last a week at the current prescription rate. We have none in stock right now.” It is expected that the government seems to be working to expand treatment options through the emergency approval of molnupiravir. The government had previously conducted a review on the emergency use of the drug in November last year but had withheld approval due to poor preventive effects. Although the MFDS did not disclose the specific schedule for approval, the government did express its intention to start the review. If so, the drug is expected to be approved this month at the earliest. The Korean government had previously signed an advance purchase agreement with Merck for 242,000 courses of its drug. If the drug is approved under the emergency approval process, the drug is expected to be distributed through the existing base pharmacies because a real-time demand monitoring system has been well established in the pharmacies and is easily manageable by the local government. Pharmacy A said, “We have received no news about molnupiravir yet, but since there are already enough base pharmacies, I don’t think the government will separately designate more for the drug.” However, as the method of administration and eligible sublets differ for the two drugs, additional education and guidance will be provided for the use of molnupiravir. Both drugs are taken twice a day for 5 days, but the total amount of capsules taken differs, 30 for Paxlovid and 40 for molupiravir. Also, the kind of side effects that arise and the subjects allowed for use differ. Earlier, the Korea Pharmaceutical Association had prepared a medication guide for patients using Paxlovid. Therefore, a medication guide for molnupiravir is also expected to be prepared after its approval and indication are finalized.
- Company
- 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.
- Policy
- Actemra is likely to be reimbursed for managing CRS
- by Kim, Jung-Ju Mar 21, 2022 05:55am
- Actemra (Tocilizumab 200mg), imported by JW Pharmaceutical and used to treat rheumatoid arthritis, is also expected to be paid for CRS management. The MOHW announced on the 18th some amendments to the "Details on the Application Criteria and Methods of Nursing Benefits" containing such contents. Actemra is a drug approved for adult rheumatoid arthritis treatment, systemic childhood idiopathic arthritis, and multi-articular childhood idiopathic arthritis. CRS develops symptoms due to excessive release of cytokines from immune cells in the process of killing cancer cells. The MOHW plans to recognize benefits when administering Actemra to CRS management. The government plans to conduct an industry opinion inquiry by the 27th with the aim of implementing it on the 1st of next month. Meanwhile, Actemra recently received EUA from the MFDS to be used for the treatment of severe COVID-19 patients over the age of 2. The drug is approved as a COVID-19 treatment in the United States, Japan, and Europe.
- Policy
- In/outpt Rx for Paxlovid are available in nursing hospitals
- by Lee, Jeong-Hwan Mar 21, 2022 05:55am
- Nursing hospitals will be able to prescribe outpatient & inpatient Rx for Paxlovid, a COVID-19 treatment. Both outpatient prescriptions that prepare and supply oral drugs at pharmacies in charge and inpatient prescriptions that receive oral drugs from hospitals dedicated to infectious diseases that supply treatments have become possible. The KDCA made the announcement at a regular briefing on the 17th. The KDCA judgment that group infections in nursing hospitals are continuing and timely administration of PO treatments for the elderly affected the permission of outpatient & inpatient prescriptions in nursing hospitals. Kim Ok-soo, head of the resource management team at the quarantine countermeasures headquarters, explained, "The nursing hospital originally tried to prescribe Paxlovid as outpatient Rx, but there was a shortage of supplies at pharmacies in charge of cities, counties and districts. Team leader Kim Ok-soo added, "The nursing hospital has improved the system since the 14th so that inpatient and outpatient Rxs can be made in a timely manner," adding, "It is a new application." Since the 14th, KDCA has taken measures to prescribe Paxlovid, a treatment to be taken when training rapid antigen tests, for those aged 60 or older, and it is necessary to secure the amount of treatment. According to the KDCA, Paxlovid for 163,000 people was supplied to Korea as of the 16th, and the inventory was 96,000 people. In addition, it is scheduled to be introduced in Korea at the end of March. The KDCA said, "We will promote the prevention of seriousness and the burden of the medical system through active administration to the elderly," adding, "We will ensure that timely administration of treatments can be made."
- Policy
- Oral myeloid leukemia treatment Onureg to be soon approved
- by Lee, Hye-Kyung Mar 18, 2022 05:56am
- The domestic marketing authorization for BMS’s acute myeloid leukemia (AML) treatment, ‘Onureg tablet (azacytidine).’ Is imminent. The safety and efficacy review for the marketing authorization of Onureg, which had received FDA approval in 2020, is now complete in Korea. According to industry sources on the 16th, the Ministry of Food and Drug Safety has completed verification on the efficacy of Onureg that BMS Korea had submitted an application for. With the safety and efficacy review complete, experts expect Onureg, the first oral azacytidine, to be released within the first half of this year. The AML treatments currently approved in Korea are Celgene’s ‘Vidaza inj.100mg,’ Boryung Pharmaceutical’s ‘Vizadakin Inj.,’ Samyang Holdings’ ‘Azalid inj. 100mg,’ and ‘Azalid inj. 150mg.’ All of the motioned drugs are injection types, therefore, if approved, Onureg will become the first oral treatment formulation to be approved in Korea. Hypomethylating agents, which are also known as CC-486, are used to treat adult AML patients who achieved CR or CRi following induction therapy with or without consolidation treatment and who are unable to complete intensive curative therapy such as HSCT. Warning and precaution for Onureg include risks of substitution with other azacitidine products, myelosuppression, increased early mortality in patients with myelodysplastic syndromes, and embryo-fetal toxicity.
- Company
- 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."
