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- 2026-04-13 04:34:39
- Company
- MSD's Delstrigo can be prescribed in general hospitals
- by Eo, Yun-Ho Dec 23, 2021 05:42am
- Delstrigo, an HIV combination that succeeded in registering insurance benefits, is preparing to enter the market in earnest. According to related industries, the HIV combination Delstrigo ( Doravirine 100 mg, Lamivudine 300 mg and Tenofir Disoproxil Fumarate), which is taken once a day by MSD Korea, has now passed the DC of medical institutions such as Sinchon Severance Hospital. The drug was approved in Korea in January last year, submitted a benefit application at the beginning of this year, and was listed in January. Delstrigo's benefit indication is "the treatment of HIV-1 infection in adults who have no previous anti-retrovirus treatment experience." Among the ingredients, Doravirine 100mg was approved by the MFDS under the brand name Pipeltro as of November 22, 2019, and is required to be administered in combination with other anti-retroviral drugs. Both Pipeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients who had no previous anti-retroviral treatment experience. Delstrigo was confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo proved non-equivalence compared to therapy of Efavirenz ·Emtricitabine·Tenofovir. The proportion of patients who reached viral inhibition (less than 40 copies/mL of HIV-1 RNA) at 48 weeks was 84% in Delstrigo treatment group and 80% in EFV/FTC/TDF treatment group. The rate of discontinuation of treatment due to adverse reactions was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. Meanwhile, Gilead, GSK, MSD, Janssen, AbbVie, and BMS are currently competing in the HIV sector, of which Gilead and GSK account for about 90% of the market.
- Company
- [2021 Pharmaceutical Patent Settlement] The target is Dukarb
- by Kim, Jin-Gu Dec 23, 2021 05:41am
- Generics' challenge was found to have been concentrated on patents for Boryung's hypertension complex "Dukarb," Novartis' heart failure treatment "Entresto," and Hanmi Pharmaceutical's asthma treatment "Monterizine. The number of companies targeting the patent alone amounts to 45 Dukarb companies, 24 Entresto companies, and 22 Monterizine companies. ◆Focus on requesting a trial on Dukarb, Entresto, and Monterizine patents According to the pharmaceutical industry on the 22nd, referees have been filed for 20 patents for 9 drugs so far this year. A total of 68 companies have requested patent trials. Patent attacks were concentrated on Boryung's Dukarb. After Arlico filed a passive trial to confirm the scope of rights for patents for complex composition in February, 44 more companies challenged. Analysts say that as the expiration of material patent of Kanarb (Fimasartan) is just two years away, it is scrambling to target patents for composite drugs. The material patent expires in February 2023. If the Dukarb patent's challenge is successful, generic companies will be able to release generics early in time for the expiration of the material patent. Dukarb has the highest prescription sales among Kanarb combinations. According to UBIST, a pharmaceutical market research firm, Dukarb was prescribed 36.1 billion won last year, followed by 30.2 billion won by the third quarter of this year. Five companies in the second half of the year gave up their challenge. Yuyu Pharmaceutical, Hanwha Pharmaceutical, Daehan New pharm, Kims, and PharmGen Science chose to give up their challenge one after another. The pharmaceutical industry is paying keen attention to whether more companies will give up patent challenges, citing the fierce competition in the ARB+CCB-based high blood pressure second-drug market. Twenty-four companies challenged Novartis' Entresto. In January, after Elyson Pharmaceutical filed a passive rights scope confirmation trial for a decisive patent, a passive rights scope confirmation trial and invalidation trial were filed for five patents registered in Entresto. In the case of Entresto, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Daewon Pharmaceutical, Dasan Pharmaceutical, Shinil Pharmaceutical, MFC, Kyperions and Corepharmbio voluntarily withdrew the passive trial to confirm the scope of rights filed in the decisive patent. Hanmi Pharmaceutical, Daewoong Pharmaceutical, and Daewon Pharmaceutical plan to continue challenging patents for use, composition patents, and pharmaceutical patents. In the case of Entresto, there is no separate material patent. Instead, patents for use and composition, which expire in 2027, are serving as material patents. Twenty-two companies have also challenged Hanmi Pharmaceutical's asthma treatment Monterizine. Monterizine is protected by four patents that expire in 2032. In September, Hanwha Pharmaceutical filed a passive rights scope confirmation trial for all four patents, followed by 21 companies joining the dispute. However, as Genuonescience voluntarily withdrew, the dispute is expected to lead to a showdown between 21 companies and Hanmi Pharmaceutical. ◆Genuone, Kyung Dong, Mothers; Tenelia MSR patent avoidance, generics can be released next year Alvogen Korea and Samsung Bioepis have filed for invalidation of three patents for Roche's targeted anticancer drug Avastin (Bevacizumab). Both companies are participating in the development of Avastin biosimilars. Alvogen Korea is said to be developing biosimilars at the global headquarters level, not at its Korean subsidiary. Daewoong Pharmaceutical filed a passive trial to confirm the scope of rights in Amgen's psoriasis treatment Otezla drug. Daewoong Pharmaceutical also filed a request for a trial on one other drug patent and a patent for use last year. At that time, Daewoong won the first trial in the patent trial. However, the case is still underway with Amgen's appeal. The dispute over patents for use has not yet ended. A patent challenge on BMS's leukemia treatment "Sprycel" also continued. Daewoong Pharmaceutical filed a trial for invalidation of the Sprycel patent in January. Boryung Pharmaceutical filed a trial on the same patent last year, and in December this year, it filed a passive trial to confirm the scope of rights for a crystalline patent. Genuonescience, along with Mothers Pharmaceutical and Kyungdong Pharmaceutical, requested a passive rights scope confirmation trial for a patent for Handok's diabetes complex "Tenelia M SR." With the victory of the dispute in May this year, they can launch generics after October 2022 when the material license of Tenelia, a single drug, expires. BCWORLD challenged Chong Kun Dang's two patents of Telminuvo. They won in October and November.
- Company
- MNC employees enjoy 17 days maximum as year-end holidays
- by Eo, Yun-Ho Dec 22, 2021 05:57am
- As in any year, the multinational pharmaceutical companies are again closing down for a long-term year-end holiday. According to Dailypharm’s research of 23 major pharmaceutical companies in Korea, 6 companies have set a 10-day or longer year-end holiday. Also, more than 10 pharmaceutical companies will be closing down for nine days. Also, in consideration of the COVID-19 pandemic, many multinational pharmaceutical companies are allowing their employees and executives to use their annual leaves to extend their holidays. Abbvie and Takeda Pharmaceutical are taking the longest days off. The companies have been closed since the 17th, for 17 days until January 2nd, 2022. Amgen’s employees are given a 13-day break, the Sanofi group 12 days, AstraZeneca 11 days, and Astellas 10 days. Companies and associations including Daiichi Sankyo, Roche, Boehringer Ingelheim, Viatris, Organon, Otsuka, Pfizer, BMS, Korean Research-based Pharmaceutical Industry Association, MSD will start their annual year-end holidays from the 25th. This means that 16 pharmaceutical companies will close their doors on Christmas Day. Most other companies including Gilead, Lilly, Merck, Biogen, Bayer, Janssen, GSK will be taking their year-end holidays by using their annual leaves. Although the employees are advised to use their annual leaves as they please, these employees will also be enjoying over 10 days as year-end holidays. Regardless of the designated holiday period, many employees have already been using their annual leaves to start their break early from this week. A pharmaceutical company official said, “Many employees are enjoying over 20 days of the holiday by using their annual leaves before and after the set days. I am pleased to be able to take the time to recharge as this year has been particularly exhausting for us and the industry with the aftermaths of COVID-19, among others.”
- Policy
- Kyprolis succeeded in renewing the RSA contract
- by Kim, Jung-Ju Dec 22, 2021 05:56am
- LG Chem's Eutropin Plus 24mg (Human Growth Hormone, Somatropin) and Eutropin Pen are included in the PVA, falling from as little as 1% to as much as 4%. In addition, Amgen Korea's Kyprolis 60mg (Carfilzomib) and Kyprolis 30mg will be adjusted to 4-5% lower prices, respectively, after successfully renewing their RSA contracts. According to the industry, until recently, these companies agreed to cut insurance prices through negotiations with the NHIS and the PVA to renew their contracts with RSA. Based on this, the MOHW is pushing for a revision of the "drug benefit list and upper limit table." If the revision is finalized soon, it will be applied as of January 1. First, the price of Eutropin Plus 24mg and Eutropin Pen falls to PVA type Na. In PVA, type "Na" is used as a mechanism to reduce up to 10% through negotiations if the upper limit has been adjusted by type "Ka," the claim of the same product group, which has been increased by more than 60% or more than 10% from the previous year's claim, or more than 5 billion won. Eutropin Plus 24mg will be reduced by 3.9% to 148,861 won and Eutropin Pen will be reduced by 1.1% to 182,787 won. Two drugs were adjusted to the reduced price after negotiating again with the NHIS after the RSA contract was terminated. Kyprolis 60mg will be reduced by 5.6% to 975,950 won and Kyprolis 30mg to 488,443 won, respectively, by 4.5%.
- Company
- JW Pharm to discuss technical partnerships for its gout Tx
- by Lee, Seok-Jun Dec 22, 2021 05:56am
- JW Pharmaceutical will be discussing technical partnerships for its key new drug candidates such as URC102 and JW2286 with global pharmaceutical companies. On the 20th, JW Pharmaceutical announced that it will be attending the ‘2022 JP Morgan Healthcare Conference’ that will be held online from the 10th next month (local time) and introduce its research projects to overseas pharmaceutical companies and global investors and conduct one-on-one virtual partnership consultations. The company plans to discuss tech partnerships for its self-developed innovative drug candidates at the conference. For example, the company will be promoting the technology export of its gout treatment URC102 to the global market, other than China. JW Pharmaceutical had signed a technology transfer agreement for URC102 with a Chinese company, Simcere Pharmaceutical, in 2019. The safety and efficacy of URC102 were demonstrated through a Phase 2b clinical trial that was completed in March. The company had also started a clinical trial to extend the eligibility of the drug to patients with nephropathies. A Phase III trial on these subjects is expected to start next year. Also, the company will promote technology partnerships for its STAT3-targeted anticancer drug, JW2286. JW2286 inhibits STAT3 and is indicated for the treatment of solid tumors, such as triple-negative breast cancer, gastric cancer, colorectal cancer, etc. The company is conducting nonclinical studies and drug manufacturing research to initiate clinical trials. STAT3 is a protein that promotes the expression of multiple genes. The abnormal activation of STAT3 causes tumor cell growth, proliferation, metastasis, and drug tolerance, but none had succeeded in developing anticancer drugs targeting STAT3 so far. Also, JW Pharmaceuticals will share its latest research and clinical development strategies on JW0061, a new drug candidate for hair loss that differentiates and promotes hair follicle stem cells involved in hair formation by activating the Wnt signaling pathway that regulates cell proliferation and regeneration, and JW1601, a drug that is extending its indication to age-related macular degeneration and ophthalmologic diseases such as allergic conjunctivitis, etc.. Around 1,500 pharmaceutical and bio companies from 50 countries attend the JP Morgan Healthcare Conference every year. Companies attend the conference to introduce their pipelines and technology to global healthcare companies. Also, participating companies are provided with an opportunity to meet with funds like venture capitals, hedge funds, PFEs, etc.
- Policy
- The MFDS approved Spikevax on the 13th
- by Lee, Tak-Sun Dec 22, 2021 05:56am
- The MFDS announced on the 13th that Moderna Korea has decided to allow manufacturing and sales items for Spikevax, which was applied on November 8. Spikevax' is a COVID-19 vaccine produced by Samsung Biologics in Korea with vaccines such as Moderna Spikevax developed in Moderna, USA, which was approved for import on May 21. Samsung Biologics receives raw material drugs and produces finished drugs through processes such as filling and marking. Spikevax is the first domestic consignment production vaccine in the mRNA method among COVID-19 vaccines licensed in Korea. The MFDS said it expects the permit to contribute to the stable supply of COVID-19 vaccines in Korea as well as to leap into a global vaccine hub. The MFDS added that it will continue to work with related ministries to strengthen the monitoring system for abnormal cases after inoculation and to provide an environment in which people can be vaccinated with confidence thorough monitoring and prompt response.
- Policy
- MFDS is speeding up the COVID-19 vaccine screening
- by Lee, Tak-Sun Dec 21, 2021 06:06am
- In 2021, the MFDS focused on speeding up the screening of COVID-19 vaccines aimed at 70% of the nation's vaccinations. As a result, the screening period for COVID-19 vaccines and treatments has been significantly advanced, contributing to the achievement of the goal. Unexpected inspections have begun on manufacturers to cope with illegal manufacturing incidents triggered by media reports. In addition, as impurity issues from overseas erupted one after another this year, drugs such as Sartan and Varenicline were recovered by inducing corporate self-inspection. Choline alfoscerate formulations, which have controversy over efficacy, were prepared in June with a clinical re-evaluation plan. ◆COVID-19 vaccine and treatment screening=As the government formalized the vaccination of the COVID-19 vaccine from the first quarter, the MFDS focused on advancing the approval period by mobilizing all personnel for product screening. As a result, vaccines were approved 40 days after receipt, and the National lot release was also completed 20 days after approval. Starting with AstraZeneca in February, Pfizer in March, Janssen in April, and Moderna vaccines in May were approved one after another. Most of them were achieved 40 days after the start of the permit review, and the National Lot Release was immediately carried out, and the vaccination began quickly. The EUA system has been enacted as a law to provide an institutional environment so that it can be urgently introduced even before formal approval. As a result, in October, Moderna vaccines commissioned by Samsung Biologics were able to receive EUA and supply them to the market. ◆Illegal manufacturing= Overseas COVID-19 vaccine confirmed the capabilities of the domestic pharmaceutical industry by selecting a domestic manufacturer as a production source, but it was also revealed that it was manufactured arbitrarily unlike permission. The MFDS, which immediately went into crackdown after hearing media reports, found that BINEX and Vivozon had illegally manufactured them in March. Additives were arbitrarily changed without permission, and some document manipulation appeared in the process. As a result, manufacturing and sales of related items were temporarily suspended and recovered. BINEX was found to have arbitrarily manufactured 32 items, including consignment and consignment manufacturing. Since then, the MFDS has set up a counter for internal complaints with the GMP special planning and inspection team and started unannounced inspections of all manufacturers. As a result, violations such as Hanall Biopharma, Chung Kun Dang, Dongin-dang, Hansol, Samsung, Jeil, and Medicakorea were found. As the MFDS proceeded with administrative measures against the caught companies, some pharmaceutical companies were treated as criminal charges. Illegal random manufacturing cases are currently under investigation by the prosecution, which is expected to have repercussions depending on the situation. ◆Choline alfoscerate, outline of clinical reevaluation= The clinical trial plan for this was finally approved in June when the MFDS issued a clinical re-evaluation order last year due to controversy over the effectiveness of the "Choline alfoscerate" drug raised by the National Assembly and civic groups. Each company decided to participate in consideration of cost and probability of success. As a result, a total of 57 companies expressed their intention to participate in the group led by Daewoong Bio and Chong Kun Dang, which have the highest sales in the market. Daewoong Bio and Chong Kun Dang conduct clinical re-evaluation of the efficacy of Choline alfoscerate's treatment of Alzheimer's dementia for 4 years and 6 months and mild cognitive impairment for 3 years and 9 months. All other indications were deleted as the revaluation effect was limited to Alzheimer's dementia and mild cognitive impairment. With the confirmation of the revaluation plan, each company has since started negotiations with the NHIS to recover benefits in the event of a clinical revaluation failure.
- Company
- "MET-targeted therapy as a new personalized NSCLC solution"
- by Eo, Yun-Ho Dec 21, 2021 06:05am
- Professor Ji-Youn Han HER2, ALK, EGFR, ROS1, NTRK. These keywords have been frequent visitors in articles on anticancer drugs recently. With the discovery that effective anticancer treatments differ depending on the patient’s genetic mutation status, personalized treatments that target specific genes of each individual are being introduced. And the development of precision medicine has heralded the paradigm shift of cancer treatments to ‘gene-specific treatment’ from ‘diseases-specific treatment.’ Amid rising expectations, the first anticancer treatment that targets the MET gene was newly introduced to Korea. The treatment, Novartis’ ‘Tabrecta (capmatinib),’ was authorized for the treatment of metastatic non-small cell lung cancer (NSCLC) with MET exon 14 deletions. The new introduction of an option in this rare type that occurs in approximately 3-4% of patients with NSCLC is gaining much attention in the medical community. Dailypharm met with Ji-Youn Han, Professor of Hemato-oncology at the National Cancer Center to hear about the use and potential of MET-targeted anticancer therapies and personalized treatment that has been implemented but is yet unfamiliar to the general public. - A treatment that targets the MET mutation has landed in Korea. What significance does the introduction of this new drug bring to the lung cancer treatment paradigm? The MET exon 14 skipping mutation is very rare in lung cancer. Various clinical trials have confirmed that exon 14 skipping mutation is an oncogenic driver mutation of lung cancer. Also, patients who have MET amplification or overexpression have very poor prognoses. In this sense, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance as the prompt introduction of MET inhibitors has become ever important. - Not many patients may be eligible to use the drug. How many will be eligible, in Korea and what other characteristics do eligible patients have? In the West, patients with MET exon 14 skipping mutations account for approximately 3% of all NSCLC patients, In Korea, the reported rate is around 2-3%. One clinical feature of the disease is that it occurs more often in elder patients than younger patients. According to clinical studies, the median age of patients was around 70. -How is the MET diagnosis environment in Korea? Several hospitals have brought in NGS testing devices after NGS-based gene panel tests were applied selective reimbursement in 2017. The MET gene is an important oncogenic driver gene that is included in most NGS panels. However, identification of MET exon 14 skipping mutation is diagnostically difficult and requires further considerations. Also, by genetic mutations, some are more fit for RNA-based NGS tests rather than DNA-based NGS tests. In particular, identifying MET exon 14 skipping mutation through a DNA-based NGS test requires further detailed diagnosis to identify hundreds of mutations that can cause exon 14 skipping mutations. On the other hand, as an RNA-based NGS test can easily discern exon 14 skipping mutations, the RNA-based NGS test may be needed to identify exon 14 skipping mutations. But in practice, RNA-based tests are used less than DNA-based tests. - Commercialization of other MET inhibitors like tepotinib is also imminent. The MET inhibitor tepotinib had differentiated patients according to treatment experience in its clinical design. According to the Phase II GEOMETRY mono-1 trial, patients who used Tabrecta as first-line had shown higher objective response rates (ORR). On the other hand, the response rate was similar in patients using tepotinib regardless of treatment history. The efficacy and safety of the two were comparable in clinical trials. The IC50 value of the two drugs that determine how much of a drug is needed to inhibit cell growth by 50%, was slightly better for Tabrecta. However, most anticancer drugs are best effective in the subject patients when prescribed at the earliest. In particular, not all patients with MET exon 14 skipping mutations who have high PD-L1 expression respond to immunotherapy treatment. Using a combination of immunotherapy-chemotherapy as first-line can increase the financial burden borne by the patients and even be less effective than Tabrecta. This is why some advanced countries like Canada believe it is necessary to thoroughly check for MET exon 14 skipping mutations by using biopsy as well as liquid biopsies in order to reduce patient burden. -Also, studies on the combined use of MET inhibitors and EGFR TKIs are also active. In particular, there are expectations that the MET inhibitors may resolve the resistance issue of 3rd generation EGFR TKIs. Around 10% of the EGFR mutated lung cancers occur due to METs. This is why a smart MET inhibitor partner may be needed to address the acquired resistance to EGFR TKI. There had been a clinical trial that tested the combined use of Tabrecta and EGFR TKI. As it is unclear which causes EGFR mutations in lung cancer - MET amplification or overexpression – the study enrolled both patients. In the trial, a patient with EGFR exon 19 deletion mutation who have experienced primary resistance participated in the trial and reached complete remission (CR). One thing to note is that we do not need to only use 3rd generation EGFR TKIs like ‘Tagrisso (osimertinib)’ when attempting combination therapies. Not only because of the price, but I believe that 1st and 2nd generation EGFR TKIs can also be sufficient partners. Also, a study on Tabrecta+Tagrisso in patients with EGFR resistance is in progress, which medical institutions in Korea are also planning to participate in.
- Policy
- What's the HIRA's solution to the drug price?
- by Lee, Hye-Kyung Dec 21, 2021 06:05am
- Measures have been prepared to improve administrative and economic losses caused by drug returns in hospitals, clinics, and pharmacies following the revision of the monthly drug benefit list and upper limit table. The HIRA has decided to provide a revision of the drug benefit list in advance starting this month. Until now, drug price files have been provided since the revision of the notice after deliberation and resolution by the Health Insurance Policy Deliberation Committee of the MOHW. However, in the future, even before the issuance of the notice, after the Health Policy Review Committee is over, the drug price file will be provided in advance from the first day of the review. The final contents of the drug price file provided in advance can be changed depending on the results of the deliberation, so it seems that it takes time to apply the billing program. It is inconvenient to use the pre-provided drug price file to check the actual transaction price when returning and settling drugs at pharmacies and to apply the final drug price file to the billing program after issuance of the notice. The reason why the HIRA came up with such an early provision of drug price files seems to be the main reason for the monthly drug price, but the suspension of execution occurs when the upper limit of the drug is adjusted due to the reduction of the benefit range. Hospitals, clinics, and pharmacies will suffer from administrative tasks such as settlement of differences in drug prices. In particular, in the case of pharmacies, if the weighted average price is incorrectly calculated due to drug price reduction or increase, it may lead to on-site investigation and administrative disposition due to inconsistency in claims.
- Policy
- MFDS cancels all Jeil’s hypertension drugs for fabrication
- by Lee, Tak-Sun Dec 21, 2021 06:05am
- The Ministry of Food and Drug Safety issued a disposition revoking the sales licenses of all hypertension drugs manufactured by Jeil Pharmaceutical after the company was found to have submitted fabricated data for approval. A total of 44 items from 15 companies including Jeil Pharmaceutical were issued the disposition. The GMP investigation that has been initiated after Binex was found to have illegally manufactured products in March has been closing on and putting the pharmaceutical companies at risk. With HLB Pharmaceutical’s ‘Twinstel tab.’ marking the start of MFDS’ dispositions, the authorities have revoked the license of 14 companies’ hypertension drugs by the 16th. The canceled products are all same ingredient drugs manufactured by Jeil Pharmaceutical. In October, Jeil Pharmaceutical was found to have fabricated its residual solvent test data among data submitted to the MFDS for authorization, upon which all related products were discontinued and recalled. The ‘MFDS Special GMP Investigation team’ that was organized after the Binex issue had conducted an investigation from September 27th to October 8th and found the above violations. Companies that have received marketing authorizations through fraudulent means are revoked their licenses under the Pharmaceutical Affairs Act. Accordingly, the MFDS had been taking steps to revoke the license of relevant items since then. The canceled items, which are all telmisartan-amlodipine besylate combinations, include the following: Jeil Pharmaceutical’s ‘Telmiduo Tab,’ Kuhnil Biopharm’s ‘Partone Tab,’ GC Cross’s ‘Greencross Telmiamo Tab,’ Dongsung Pharm’s ‘Telmisapin Tab,’ Mcnulty Pharmaceutical’s ‘Mac duo Tab,’ Myungmoon Pharm’s ‘Telmiones Tab,’ Sungwon Adcock Pharm’s ‘Twinstan Tab,’ HLB Pharmaceutical’s ‘Twinstel Tab,’ LG Chem’s ‘Novarsc T Tab,’ Yungjin Pharm’s ‘Astel Tab,’ Yu & Life Science’s ‘Telosapin Tab,’ Joonghun Pharm’s ‘Telostar Tab,’ Theragen Etax’s ‘Twincure Tab,’ and Pharvis Korea’s ‘Troika Tab,’ As of the 16th, products from 36 companies have been revoked their licenses. Most were caused by Jeil Pharmaceutical’s license revocation due to data fabrication and other items were also caught on charges of arbitrarily manufacturing products and revoked permissions. Companies that were caught with violations this year include Medica Korea, Jeil Pharmaceutical, Samsung Pharm, Hansol Pharm, Dong In Dang Pharmaceutical, Chong Kun Dang, Hanall Biopharma, Vivozon, and Binex. Among these Binex was sent to prosecution by the MFDS’s Central Criminal Investigation Office for violating the Pharmaceutical Affairs Act.
