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- 2026-04-09 06:29:32
- Company
- Trajenta, unregistered patent challenge spreads
- by Kim, Jin-Gu Oct 10, 2023 05:27am
- Challenges to Trajenta's unlisted patents have expanded further. The number of patents targeted by generic companies increased from 8 to 11. According to the pharmaceutical industry on the 5th, Kukje Pharmaceutical recently requested a passive rights scope confirmation trial for three Trajenta-Duo formulation patents. These three formulation patents were previously outside the scope of patent challenges by generic companies. These include ▲10-1775942, ▲10-1763659, and ▲10-1611314, which expire in April 2029, respectively. Kukje Pharmaceutical found three new cases that were not listed in the Ministry of Food and Drug Safety's patent catalog and took on the challenge. Challenges to Trajenta and Trajenta Duo's unregistered patents have continued steadily since the end of last year. Last September, Genuine Science requested a passive rights scope confirmation trial for the Trajenta formulation patent (10-2051281). Korea United Pharmaceutical, Shinil Pharmaceutical, Hutecs, Hanlim, Aprogen Biologics, Ilhwa, and Kukje Pharmaceutical requested the same judgment. In October last year, an invalidity trial was requested for three Tragenta use patents (10-1558938, 10-1806786, and 10-1655754). Genuonesciences, Boryung, Mothers Pharmaceutical, Kukje Pharmaceutical, GC Pharma, and Dongkoo took up the challenge. In the same month, Genuonesciences filed a request for invalidation of the Trajenta manufacturing method patent (10-1541791). In April of this year, Shinil Pharmaceutical, Korea Hutex Pharmaceutical, Hallym Pharmaceutical, and Daewon Pharmaceutical filed a series of requests for invalidation trials and passive rights scope confirmation trials for two Trajenta pharmaceutical patents (10-2051281 and 10-1855323). In the same month, a passive rights scope confirmation trial was requested for another pharmaceutical patent (10-1710881). Shinil Pharmaceutical, Korea Hutex Pharmaceutical, Hallym Pharmaceutical, Korea United Pharmaceutical, Aprogen Biologics, Ilhwa, and Kukje Pharmaceutical took up the challenge. Then, in June of this year, Genuine Science, Kukje Pharmaceutical, and Kyungbo Pharmaceutical filed a request for invalidation of the Trajenta use patent (10-2427380). With the recent addition of 3 cases to the situation where evasion and invalidation trials were requested for 8 previously unlisted patents, the total number of unlisted patents for Trajenta and Trajenta Duo that have become targets of generic companies has expanded to 11. An unregistered patent is a patent that has been registered with the Korean Intellectual Property Office but is not listed in the Ministry of Food and Drug Safety's patent catalog. Since it is not listed in the patent catalog, it is cumbersome for patent challengers to have to search patent information one by one, discover unlisted patents, and request a trial. Furthermore, even if a product is released after overcoming various unlisted patents, unlisted patents that have not yet been found may hinder the product launch. If a product is released in this state, there is a high possibility that the generic company will be interpreted as infringing on the patent. Applications for temporary injunctions to ban product sales due to patent infringement and lawsuits for damages may follow.
- Policy
- Tepmetko attempts reimb again in KOR
- by Lee, Tak-Sun Oct 10, 2023 05:27am
- Merck is reattempting reimbursement listing of its MET-targeted anticancer therapy ‘Tepmetko (tepotinib)’ in Korea. The drug was unable to pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in February. The company voluntarily withdrew its reimbursement process at the time. The company had later reorganized the data to reapply for reimbursement. According to the industry on the 6th, Merck Korea recently applied to request a reimbursement decision for its Tepmetko to HIRA. Tepmetko is a treatment for locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 skipping mutations. It was approved in Korea in November 2021. Afterward, Tabrecta Tab (capmatinib), a same-class drug, also sought reimbursement in Korea. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). Due to the lack of suitable treatments, expectations had been high for anticancer drugs targeting the disease. However, both drugs are having difficulty being listed for reimbursement. Tepmetko failed to set reimbursement standards at the Cancer Disease Deliberation Committee meeting that was held in February this year. Tabrecta also failed to pass HIRA review. The HIRA's Drug Reimbursement Evaluation Committee decided not to reimburse Tabrecta, saying there was insufficient evidence to judge its clinical usefulness. Despite such delays in reimbursement, Tepmetko has landed in major general hospitals in Korea and became available for prescription. This is proof that its need is well recognized in the field. Tepmetko’s efficacy was evaluated through the VISION study, which enrolled the largest number of patients among clinical trials targeting NSCLC patients with MET exon 14 skipping mutations. Results showed a significant life extension effect with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8%. Also, the median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term. With its need in the medical field rising, expectations are also rising for the second time to be the charm for Tepmetko’s reimbursement.
- Company
- Disadvantages of effective ADC anticancer drugs
- by Oct 10, 2023 05:27am
- It has been shown that patient accessibility to antibody-drug conjugates (ADCs) introduced in Korea has been significantly reduced due to high non-reimbursed drug prices. The price of non-reimbursed Trodelvy, which was approved in Korea last May, is about 1.6 million won per vial. Converted into one cycle (21 days, 2 administrations), the cost is approximately 9.3 million won, which is close to 10 million won. Enhertu’s non-reimbursed drug price is also high. The non-reimbursed price of Enhertu, which requires three vials per cycle for an average patient is about 7 million won. If you participate in the Patient Assistant Program (PAP) run by the company, the price drops to the high 5 million won range, but it is still a burden for the patient. ADC has recently emerged as a hot keyword in the anticancer drug market. Newly introduced ADC anticancer drugs in Korea, such as Daiichi Sankyo Enhertu and Gilead Trodelvy, are effective against a variety of cancer types, not just one cancer type. Enhertu, which was approved in Korea last year as a treatment for human epidermal growth factor receptor type 2 (HER2) positive breast and stomach cancer, showed superior results compared to existing treatments in clinical data such as PFS and OS. Enhertu is also showing effectiveness in clinical trials targeting patients with HER2-low-expressing breast cancer, non-small cell lung cancer, colon cancer, ovarian cancer, and biliary tract cancer. Trodelvy, which targets TROP-2 protein, is also seeking to secure various indications. Currently, it has been approved as a treatment for triple-negative breast cancer in Korea, but its efficacy and safety are also being checked for HR+/HER2- breast cancer and non-small cell lung cancer. Accordingly, various domestic companies are also taking on the challenge of ADC development. This is because, if development is successful, there is a high possibility of securing various indications. Currently, not only traditional pharmaceutical companies such as Samjin Pharmaceutical, Anguk Pharmaceutical, and Chong Kun Dang, but also bio companies such as Celltrion, Samsung BioLogics, Lotte BioLogics, and LegoChem Bio have declared their participation in the ADC market. ADCs have the advantage of securing excellent therapeutic effects and a variety of indications, but the high drug price is an obstacle to prescription. As a result, some patients are giving up treatment. This is because patient copayment occurs even with actual cost insurance. In particular, the longer the treatment period for Enhertu and Trodelvy, which showed an advantage in PFS compared to existing treatments, the greater the burden on patients. Professor Kyeong-Hwa Park of the Department of Oncology at Korea University Anam Hospital (Chairman of the Korean Cancer Society) said, “ADCs are effective even in cancer types that have had poor treatment results so far, so there are many patients who want to use them, but the non-reimbursed drug price is an obstacle,” adding, “It has a large impact on the family economy.” In addition to ADCs, there are also situations where a general anticancer drug is switched. “Even patients with actual cost insurance face a significant burden as they incur a 20% copayment per month,” the professor said. However, he explained that there is a reason why ADC non-reimbursed drug prices are high. Unlike existing anticancer drugs, ADC's manufacturing process is different from general chemical principles. Professor Park said, “ADC has a high manufacturing cost because it involves a process of generating antibodies and linking the payload. In the case of Kadcyla, a first-generation ADC, it is known that 10 molecules of Herceptin must be reacted to obtain one molecule. “It is understandable that non-reimbursed drug prices are high,” he said, adding, “I sympathize with the positions of both the government, which wants to reduce health insurance finances, and the company, which must protect development costs, but I hope that an agreement will be reached as soon as possible and the reimbursement will be passed.” He continued, “I hope that in the future, not only overseas pharmaceutical companies but also domestically will succeed in developing ADCs and contribute to stabilizing health insurance finances by lowering drug prices.”
- Company
- GSK’s momelotinib receives orphan drug designation in KOR
- by Eo, Yun-Ho Oct 10, 2023 05:26am
- The new myelofibrosis drug momelotinib has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety announced so through an orphan drug designation notice issued on the 6th. Momelotinib is a treatment for myelofibrosis that blocks the major signaling pathways for JAK1, JAK2, and activin A receptor type 1 (ACVR1). The drug was a candidate drug for Sierra Oncology, but was acquired by GSK last year for USD 1.9 billion (KRW 2.56 trillion) and recently received final approval from the US Food and Drug Administration. Based on its mechanism of action, momelotinib is known to improve systemic symptoms and splenomegaly (enlarged spleen) by inhibiting JAK1 and JAK2, while directly inhibiting ACVR1 to reduce the level of circulating hepcidin, which contributes to anemia. Results of the Phase III MOMENTUM trial conducted on patients with myelofibrosis that was published in the global medical journal, The Lancet, showed that the drug demonstrated significant results in myelofibrosis patients with anemia, where treatment limitations had previously existed. The MOMENTUM study investigated momelotinib versus danazol in 195 patients with myelofibrosis who were symptomatic and anemic and had been previously treated with an approved JAK inhibitor at 107 sites in 21 countries. The primary endpoint was the total symptom score response (≥50% reduction from baseline) rate assessed through MFSAF(Myelofibrosis Symptom Assessment Form). Study results showed that 25% of patients treated with momelotinib met the primary endpoint as compared with 9% in the danazol arm. Also, at 24 weeks, 40% of patients in the momelotinib arm achieved a spleen volume reduction of at least 25% from baseline at week 24, 35% of which did not require transfusion at week 24. The levels were 6% and 17% respectively for the danazol arm. Meanwhile, myelofibrosis is a disease in which fibrous scar tissue replaces blood-producing cells in the bone marrow, and is characterized by abnormally shaped red blood cells, anemia, and an enlarged spleen.
- Company
- Hemgenix receives orphan drug designation in KOR
- by Eo, Yun-Ho Oct 10, 2023 05:26am
- The one-shot gene therapy for hemophilia, Hemgenix, has been designated as an orphan drug in Korea. On the 6th, the Ministry of Food and Drug Safety announced so through an orphan drug designation notice. Hemgenix (etranacogene dezaparvovec-drlb), which is the first and only one-time gene therapy approved for the treatment of adults living with hemophilia B, was first approved by the FDA in November last year. The drug can be used to treat adults with hemophilia B who: currently use Factor IX prophylaxis therapy, have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Hemgenix’s efficacy was confirmed through the pivotal HOPE-B study, the largest gene therapy study in hemophilia B to date. Study results showed that the mean factor IX activity of hemophilia B patients had increased to 36.9 IU/dL after infusion, and showed durable and sustained stable activity levels. Also, the drug reduced the annual bleeding rate (ABR) by 64%. Also, 9 96% of patients discontinued routine Factor IX prophylaxis and mean Factor IX consumption was reduced by 97% at 18 months post-treatment. The drug continued to show effect in the HOPE-B 24-month extension study. There were no serious treatment-related adverse events in the clinical study setting, and the drug was generally well tolerated. Hemophilia B is a congenital bleeding disorder caused by a single gene defect and is caused by a deficiency in coagulation factor IX (blood coagulation factor 9), a protein that helps blood coagulation and is mainly produced in the liver. Moderate-to-severe Hemophilia B is treated using prophylactic infusions of factor IX to temporarily replace or supplement low blood clotting factor levels. Although effective, patients are burdened with having to strictly adhere to a lifelong infusion schedule. Also, patients can experience pain, limited mobility, joint damage, and spontaneous bleeding due to the disease. When these patients are injected with Hemgenix intravenously, they can produce blood coagulation factor IX on their own, lowering the risk of bleeding.
- Policy
- Will Leclaza also begin drug price negotiations soon?
- by Lee, Tak-Sun Oct 10, 2023 05:26am
- The expansion of reimbursement for Leclaza, a third-generation EGFR TKI non-small cell lung cancer treatment developed by Yuhan Corporation, as a first-line treatment will be discussed at the HIRA Pharmaceutical Reimbursement Evaluation Committee on the 12th. If the Pharmaceutical Reimbursement Evaluation Committee recognizes the adequacy of the benefit on this day, the drug price will be negotiated with NHIS and placed on the final benefit list. According to the industry on the 6th, Leclaza is on the agenda for deliberation by the evaluation committee to be held on the 12th. The Pharmaceutical Review Committee deliberates on the registration of new benefits, expansion of benefits, and adjustment of the maximum amount of drugs. A total of 40 people, including 17 committee members and government officials, will attend. Leclaza was approved as a first-line treatment for non-small cell lung cancer last June. It is the second third-generation EGFR TKI treatment for non-small lung cancer, following Tagrisso. However, the speed of salary registration is almost the same as Tagrisso. While Tagrisso's reimbursement standards were set by the HIRA Cancer Disease Review Committee last March, five years after approval from the Ministry of Food and Drug Safety, Leclaza's reimbursement standards were established two months after approval last August. If it passes the Pharmacy Review Committee this time, the gap in registration speed with Tagrisso will be further reduced. Tagrisso passed the committee held on the 7th of last month. There is also a possibility that the two drugs may be listed on the insurance plan at the same time through NHIS drug price negotiations. Once the drug price negotiation is concluded, it will be included in the final benefit list after deliberation by the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. The domestic market size for first-line non-small cell lung cancer treatment is said to be approximately 300 billion won. If the third-generation treatment that has proven its excellence in effectiveness becomes the first-line treatment, it is expected to record high sales performance. Recently, Yuhan's stock price has risen by 40% in three months as expectations for Leclaza's expanded first-line treatment coverage and entry into the global market have grown.
- Company
- Dongkook succeeds P3T for its BPH combination drug
- by Chon, Seung-Hyun Oct 06, 2023 05:37am
- On September 25th, Dongkook Pharmaceutical announced that it had confirmed the safety and efficacy of its incrementally modified combination drug for benign prostatic hyperplasia (BPH), ‘DKF-313,’ through a Phase III trial. Based on the positive results, Dongkook Pharmaceutical plans to complete the Phase III trial result report within the year, then apply for its marketing authorizations and release. Pic of Dongkook Pharmaceutica HQ DKF-313 is the world’s first combination of dutasteride and tadalafil. According to Dongkook Pharmaceutical, its combo drug has a dual effect of reducing prostate size while improving urinary disorder symptoms from BPH and can bring better treatment effect than single-agent drugs. The company said, “We were able to confirm the superior effect of DKF-313 in the trial. The drug is expected to improve the convenience and quality of life for patients ailing from a condition that requires long-term medication, as the drug comes in a once-daily, one-tablet dosage form." The company received approval to initiate a Phase 3 trial for DKF-313 from the Ministry of Food and Drug Safety in July 2020 and began full-scale clinical trials to enroll about 650 patients from 18 hospitals nationwide in 2021. Dongkook Pharmaceutical took charge of the development of DKF-313, and three domestic pharmaceutical companies, including Dong-A ST, Shinpoong Pharm, and Dong Koo Bio & Pharma, shared the cost as participants. If the drug succeeds in commercialization, the partner companies will each gain marketing authorization and release it simultaneously. The incrementally modified version of this combination drug will be manufactured and supplied at a facility of the organizing company, Dongkook Pharmaceutical. Professor Choung-Soo Kim, Director of the Prostate Cancer Center at Ewha Womans University’s Mokdong Hospital, said, “The combination demonstrated superiority in improving the International Prostate Symptom Score (IPSS) compared to each agent alone, and there was no statistically significant difference between the combination and single-agent drugs in terms of adverse drug reactions. If the results lead to product launches, it may provide new and significant support in improving the treatment and quality of life of the patients.” A Dongkook Pharmaceutical official said, “We plan to strengthen our stronghold in the domestic market based on our domestic and overseas network and sales power and expand our scope overseas and penetrate the global market.”
- Policy
- Pfizer applies for reimb of its COVID-19 Tx Paxlovid
- by Lee, Tak-Sun Oct 06, 2023 05:36am
- Pfizer applied for the reimbursement of its COVID-19 treatment 'Paxlovid' in Korea. With the government planning to end the current free support system for COVID-19 treatments in the 1H next year, the company has begun the process of applying for reimbursement accordingly. According to the industry on the 5th, Pfizer Korea recently submitted a drug decision application for its COVID-19 treatment ‘Paxlovid Tab’ to the Health Insurance Review and Assessment Service. Paxlovid was first introduced to Korea through the Emergency Use Authorization system in December 2021. At the time, the need for oral treatment was raised due to the increased number of confirmed COVID-19 cases and critically ill patients and the spread of the Omicron variant, leading to the prompt introduction of Paxlovid. On July 18, the drug received official marketing authorization from the Ministry of Food and Drug Safety. Until now, Paxlovid had been provided 100% free of charge through government support. However, the government announced a provisional plan to convert COVID-19 into a level 4 infectious disease starting August 31 and end the free support for COVID-19 treatments from the 1H next year, raising the need for Paxlovid’s reimbursement. Without reimbursement, a single set of Paxlovid for 5 days will cost KRW 700,000. Also, Pfizer Korea announced at a press conference celebrating the official approval of Paxlovid in July that it was discussing with the government to quickly list the drug before 1H of next year. If reimbursed, patients will be able to use it cheaper through national health insurance support. The drug had established itself as Pfizer’s cash cow, posting global sales of $4.069 billion (KRW 5.4492 trillion) in Q1 last year.
- Product
- Investigation into companies refusing to supply animal med.
- by Kim JiEun Oct 06, 2023 05:36am
- The Korean Pharmaceutical Association (Chairman Choi Kwang-hoon) took out its sword against pharmaceutical companies that refused to supply veterinary medicines to pharmacies. Kang Byeong-gu, director of animal medicine at the Korean Pharmaceutical Association, appeared at Seoul Namdaemun Police Station as a complainant on September 26 and was investigated. Last August, the Pharmaceutical Association reported Boehringer Ingelheim Korea Animal Pharmaceuticals to Seoul Namdaemun Police Station on charges of violating the Pharmaceutical Affairs Act. This is a criminal complaint for violation of the Pharmaceutical Affairs Act, unlike the case of violation of the Fair Trade Act in 2013 when some animal drug manufacturers refused to supply products to animal pharmacies. The Pharmaceutical Association believes that Boehringer Korea Veterinary Pharmaceuticals' refusal to supply medicines violates Article 47 of the Pharmaceutical Affairs Act (Sales Order of Medicines, etc.) and Article 22 of the Rules for Handling Veterinary Medicines, etc. (Compliance Matters for Veterinary Medicine Manufacturers, etc.) The Pharmaceutical Association explains that Boehringer's actions interfere with the preparation and administration of medicines at veterinary pharmacies and are likely to encourage collusion by supplying veterinary medicines only to certain wholesalers and veterinary hospitals. In his appearance at this police investigation, Director Byeong-gu Kang stated that he had requested a thorough investigation into problems with Boehringer Ingelheim's veterinary drug distribution policy. Kang Byeong-gu, director of animal medicine, said, “An animal guardian who has been issued an out-of-hospital prescription by a veterinarian visits an animal pharmacy to dispense a prescription, but the animal pharmacy is unable to supply veterinary medicine for dispensing,” adding, “The Pharmaceutical Association has sent an official letter requesting product supply to the relevant pharmaceutical company.” However, we received a response from Boehringer refusing to supply,” he said. Director Kang said, “A thorough investigation must be conducted into pharmaceutical companies that violate the Pharmaceutical Affairs Act. Starting with this complaint, we will normalize the distribution channel of veterinary medicines while continuing to take action against manufacturers that refuse to supply veterinary medicines.”
- Policy
- Reducing criminal liability for essential healthcare
- by Lee, Jeong-Hwan Oct 06, 2023 05:36am
- The ruling party proposed legislation to reduce criminal liability for doctors embroiled in medical malpractice suits while providing essential health services, and for the state and local governments to support and foster essential healthcare personnel. The legislation is in line with the Yoon Suk Yeol administration's policies to strengthen essential healthcare. With regards to how the government considers it as the biggest agenda in health and welfare, the medical community, led by the Korean Medical Association, had been consistently requesting the legislation of 'exemption of criminal liability for doctors providing essential healthcare services.’ On the 5th, Rep. Suk-Joon Hong of the People Power Party proposed the ‘Bill for the Promotion and Support of Essential Healthcare’ as representative that contained the contents above. Rep. Hong pointed out that a gap existed in protecting the lives and health of the people in Korea due to the recent lack of essential healthcare infrastructure. In particular, some essential healthcare treatment departments are facing a serious shortage of personnel, so measures to foster and support essential healthcare are urgently needed. In addition, in fields that provide essential healthcare services such as childbirth, the risk of medical accidents is relatively high, and excessive criminal punishment places an excess burden on the doctors, leading to an increase in the doctors’ avoidance of essential healthcare services. Therefore, Rep. Hong proposed a bill to encourage the national and local governments to prepare and promote policies to support and promote essential healthcare, and to reduce criminal liability for medical malpractice suits in essential healthcare under strict requirements. The bill’s main purpose is to contribute to protecting and improving public health by resolving the avoidance of practicing essential healthcare and preventing the collapse of Korea’s essential healthcare system.
