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- 2026-04-12 05:55:22
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- TNBC will be added to Keytruda's indications
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- TNBC indications of the immuno-cancer drug Keytruda are expected to be added. According to related industries, the MFDS is currently conducting a last-minute review for further approval of the combination of chemotherapy in the first round of Triple-Negative Breast Cancer (TNBC) by PD-1 inhibitor Keytruda. Permission is expected within the third quarter. Since the approval of the U.S. FDA last year, MSD has been rapidly proceeding with the approval process. Keytruda's effectiveness in TNBC has been demonstrated through KEYNOTE-355 studies. In this study, Keytruda recorded 53% ORR (CR 17%, PR 36%) with PFS improvement in the entire patient population with a rapid recurrence of more than 6 months, suggesting the possibility of complete recovery in metastatic triple-negative breast cancer with high complete remission rates. On top of that, Keytruda recently proved its effectiveness in adjuvant therapy before and after surgery. As a result of exploratory analysis of the KEYNOTE-522 study published at the American Society of Clinical Oncology (ASCO) annual conference, both the keytruda administration group and the control group tended to increase the incidence of events rapidly as the size of residual tumors increased. In addition, with the exception of RCB-3, which has the largest size of gin tumors, the risk of occurrence of events in the Keytruda group was all lower than that of the control group. Among breast cancer, TNBC, which has negative reactions to all receptors (Estrogen, Progesterone, and HER2), has long been an unsolved challenge. TNBC's treatment options have long been all about chemotherapy and Roche's targeted anti-cancer drug, Avastin (Bevacizumab) acquired the first indication in Korea, but it is still nonreimbursed. Since then, a poly ADP ribose polymerase (PARP) inhibitor Lynparza has been added as a target anticancer option, and Roche's PD-L1 inhibitor Tecentriq has entered as the first immuno-cancer drug.
- Policy
- Hanmi obtains generic exclusivity for Dapalon Duo
- by Lee, Hye-Kyung Jun 20, 2022 06:03am
- Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride). The Ministry of Food and Safety recently granted marketing authorizations for the four strengths of Dapalon Duo - Dapalon Duo 5/500mg, 10/500mg, 5/1000mg, and 10/1000mg. Its original drug is AstraZeneca’s Xiguo XR Tab, and Hanmi is the second company to receive first generic exclusivity for its four strengths after Chong Kun Dang. The generic exclusivity will be in effect from April 8th, 2023 to January 7th, 2024. Hanmi Pharmaceutical’s Dapalon Duo is a combination of dapagliflozin bis L-proline and metformin hydrochloride that uses a different solvate from the original Xigduo XR Tab on its active ingredient, dapagliflozin. Meanwhile, 53 Xigduo generic items from 24 companies have received marketing authorization, among these, 12 items from Chong Kin Dang, KyungDong Pharm, Ildong Pharmaceutical, Boryung Pharmaceutical, and Jeil Pharmaceutical have been granted generic exclusivity. The solvent patent for the original drug was set to expire on June 21st, 2027, but the invalidation claim filed by the latecomers in Korea has been accepted and has left the patent invalid. As the companies of latecomers have won the first and second trials to invalidate Xigduo’s the second substance patent which is set to expire on January 8th, 2024, the companies will be able to sell the latecomer items upon the expiry of the first substance patent that expires on April 7th, 2021. Xigduo’s outpatient prescriptions (UBIST) amounted to 36.9 billion last year.
- Company
- Hee-Mok Won to “strengthen ties with Korean talents in US"
- by Kim, Jin-Gu Jun 20, 2022 06:03am
- The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced on the 16th that it will establish a communication and cooperation network with Korean talents that serve key roles in regulatory agencies, pharmaceutical companies, and venture capital (VCs) in the US to support the domestic companies’ entrance into the US market. Hee-Mok Won, Chairman of KPBMA has recently visited the US to attend the 2022 BIO International Convention (2022 BIO USA) and the opening ceremony of the Korea Bio-Innovation Center in Boston. During his visit, Won had also participated in the “Seminar & Dinner Symposium for the Korean Pharma-Bio’s entry into the US market (Korea Night 2022).” The event was organized by the Ministry of Health and Welfare, the Ministry of Trade, Industry and Energy, and the US Embassy, and was jointly hosted by the KPBMA, Korea Health Industry Development Institute, KOTRA, and KoreaBIO. At the event, Won said, “Let us bring a successful era of K-Pharm together by creating a diversified, in-depth network that connects Korean talents that work in various fields related to the Pharma-Bio industry in the US.” Won added, “KPBMA has actively been supporting our member companies’ entrance to Boston, the world's largest bio cluster since 2019. We will also actively support cooperation between companies in bio clusters in Maryland, Silicon Valley, and San Diego bio clusters in the future." Before attending the event, Won had met with Korean experts that are serving key roles such as IND, NDA, and BLA reviews at the FDA and NIH in Washington DC on the 10th. Over 250 known Korean experts and 1,000 Korean experts are known to be working in the FDA and NIH.. On the same day, Won had also met with Korean-American Professional Association in Life Sciences (KAPAL) executives including its President Byung Ha Lee to discuss ways to support the Korean companies’ entry into the US. The two associations agreed to discuss specific measures for cooperation in the second half of the year. On the 13th, Won met with executives of Korean American Society in Biotech and Pharmaceuticals (KASBP) in San Diego to discuss measures for cooperation in the Life Sciences. As such, the chairman had met with Korean-Americans that are playing key roles in sectors related to the US pharmaceutical and bio-industry during his visit to the US. He also met with Perry L. Fri, Executive Vice President of the US Healthcare Distribution Alliance (HDA), to work for KPBMA to join the HDA. HDA represents US drug distributors and has 35 distributors and 125 manufacturers as corporate members. KPBMA’s membership in HDA is expected to allow domestic companies to participate in education and training programs in the US distribution market. Won said, “In order for the Korean biopharmaceutical industry to go beyond the domestic market and confidently compete on its own in the global market, it must first actively interact with key US pharmaceutical bio clusters, including those in Boston and San Diego."
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly conduct BA tests and re-evaluate the price of listed drugs in July 2023 after a three-year grace period. Accordingly, the HIRA will receive data from pharmaceutical companies to prove whether they meet the standard requirements from October to February next year. The question is whether the item will be able to submit related data by the deadline as it has expanded to the aseptic formulation for BA test since October this year. The HIRA plans to consult with the MFDS on necessary measures such as the selection of control drugs for data submission. According to the industry on the 16th, the HIRA will hold a briefing session from 1:30 p.m. on the 22nd at the White Veil located in Seocho-gu, Seoul. It is expected that the number of pharmaceutical companies related to the re-evaluation of the listed drug, which is a face-to-face explanation circuit that takes place for the first time in a long time, will exceed the capacity of the place. The HIRA plans to re-evaluate listed drugs with the aim of applying them in July 2023 as scheduled. Accordingly, pharmaceutical companies are requesting to submit data to prove whether they meet the standard requirements from October to February next year. The core of the data is whether to prove equivalence through BA and others. Most of the requirements for using registered raw materials drugs are expected to be met. To this end, pharmaceutical companies have conducted BA tests by converting consigned manufactured items that have not undergone BA tests into their own production items. The problem is that the drugs will also be subject to the BA test from October, when the data is submitted. The health authorities say these aseptic drugs are subject to re-evaluation of drug prices. After October, the equivalence must be demonstrated through the BA test for aseptic drugs such as injections or the chemical equivalence test that replaces them. The problem is that comparators for tests will not be announced until after October. The pharmaceutical industry believes that it may be difficult to submit data by February next year if the process of selecting a contrast agent is delayed. An official from a pharmaceutical company pointed out, "It is unlikely that companies with many items will be able to manage their schedules," adding, "Aseptic drugs subject to BA tests in October need to extend the deadline for submitting data or hurry to announce control drugs." The MFDS is aware of this. Accordingly, the government plans to apply for and announce the control group drug from time to time, and improve the recognition process. At a meeting with the Korea Special Press Association on the 14th, Kim Ae-ryeon, head of the HIRA drug management office, said, "There is a need for consultation with the MFDS regarding the designation of contrast agents." In March, the HIRA unveiled 3,372 product groups of control drugs and first-time registered products that are excluded from revaluation among 33,618 listed items. As a result, it is expected that items subject to re-evaluation, including aseptic drugs, will be clearly disclosed at the briefing session on the 22nd.
- Company
- Myungin challenges generic for exclusivity of Brintellix
- by Jun 20, 2022 06:03am
- Domestic pharmaceutical companies have launched an antidepressant Brintellix first generic challenge. According to the pharmaceutical industry on the 16th, Myungin and Unimed filed an application with the MFDS this month to approve generics of Lundbeck Korea Brintellix. It has been five months since the two companies filed a trial to confirm the invalidity and passive scope of rights of the original patent. In February, the two companies developed and started with BA test approval from the MFDS. This is because pharmaceutical companies that filed the first patent lawsuit at generics and applied for permission can obtain generic for exclusivity. If acquired generic for exclusivity, it can be monopolized generic sales for nine months. Brintellix is an antidepressant with a multi-action mechanism approved by Lundbeck Korea in August 2014. It directly controls serotonin receptors involved in depression and inhibits reabsorption, resulting in an antidepressant effect. Through the combined action, side effects such as sexual dysfunction, weight gain, and sleep disorder, which are commonly seen as depressant treatments, have been improved. In particular, it was also effective in improving cognitive dysfunction, a representative symptom of depressed patients. Lundbeck Korea's annual sales amount to about 9 billion won. A total of four pharmaceutical companies, including Myungin and Unimed, have filed for judgment on the Brintellix patent. If Myungin and Unimed succeeds in the patent challenge, it will satisfy the initial request for trial and the initial application for permission and obtain generic for exclusivity.
- Company
- The α-GPC's sentence of lawsuit has been postponed again
- by Chon, Seung-Hyun Jun 20, 2022 06:03am
- The sentence of the "cancellation of benefit reduction" lawsuit of the brain function improvement drug Choline Alfoscerate has been postponed again. According to the industry on the 16th, the 6th part of the Seoul Administrative Court changed the date of the lawsuit for cancellation of the notification of the application of health insurance drugs screening benefits scheduled for the 17th to July 22. It is a trial of a lawsuit filed by Chong Kun Dang Group to cancel the reduction of α-GPC benefit. In August 2020, the MOHW issued a partial revision notice of "details on the criteria and methods of care benefits" containing the contents of α-GPC's new benefit standards. If a patient who has not been diagnosed with dementia uses α-GPC, the burden of drug prices rises from 30% to 80%. Pharmaceutical companies have filed a lawsuit for cancellation of the unfairness of reducing α-GPC benefits. The lawsuit was filed in two cases according to the legal representative. Sejong, a law firm, filed a lawsuit on behalf of 39 companies and 8 individuals, including Chong Kun Dang, while the law firm Square was in charge of one lawsuit with 39 companies, including Daewoong Bio. This is the second postponement of the sentencing date of the Chong Kun Dang Group trial. The court announced February 22 as the date of the ruling, but the defense resumed as the court changed. After continuing to plead on April 29, the sentence was announced on the 17th of this month, but the date of the sentence was postponed again on the 15th. Daewoong Bio Group's lawsuit to cancel the reduction of α-GPC benefit is still undergoing the first trial. A ruling was scheduled for March 17, but the defense resumed. Pharmaceutical companies have requested a suspension of execution to suspend the implementation of the benefit reduction notice until the main lawsuit, and both groups have been sentenced to the Supreme Court.
- Company
- FDA grants ODD to LG Chem’s oral genetic obesity drug
- by Chon, Seung-Hyun Jun 20, 2022 06:03am
- LG Chem announced on the 16th that the US Food and Drug Administration has been additionally granted orphan drug status to its new genetic obesity drug ‘LB54640.’ The FDA has recently designated LB54640 as an orphan drug for the treatment of pro-opiomelanocortin (POMC) deficiency.’ The FDA has been operating an Orphan Drug Designation (ODD) system to encourage and support the development of treatments for rare and intractable diseases that affect less than 200,000 persons in the US. The number of POMC patients suffering from genetic obesity in the US is estimated to be around 120,000. With the designation, LG Chem will be receiving benefits such as 7-year marketing exclusivity in the US market, support for clinical trial costs, tax credit, and development-related pre-consultation support for the drugs’ development. LB54640 had formerly received FDA ODD as a treatment for ‘leptin receptor deficiency’ in September 2020. LB54640 is a targeted, once-daily oral treatment that targets the pathway of the MC4R (melanocortin 4 receptor) protein that is involved in appetite sensation. It induces appetite suppression by directly acting on the MC4R protein that delivers the final signal of fullness even if defects exist in its upper pathway genes (LEPR, POMC, etc.). LG Chem has recently completed a Phase I trial on LB54640 in healthy overweight adults without genetic defects and plans to announce its results within this year. Then, the company will be entering global Phase II/III trials on genetically obese patients with LEPR or POMC genetic deficiencies from next year. LG Chem said, “We plan to provide a differentiated treatment experience with our new oral drug through its improved convenience in the rare obesity treatment market that is currently occupied by injection-type formulations.
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 20, 2022 06:02am
- The MFDS (Director Oh Yoo-kyung) announced on the 15th that it will change the efficacy, and indication precautions of "JAK Inhibitor", which is used as a treatment for inflammatory diseases. Patients can be used the same as before, but high-risk patients such as those aged 65 or older, high-risk cardiovascular groups, and risk of malignancy will be available only if the effect is insufficient with the existing treatment. JAK Inhibitor is used to treat various inflammatory diseases such as rheumatoid arthritis by blocking the action of JAK, an enzyme that controls immunity and inflammation, and 65 items of Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib are licensed in Korea. This measure is a follow-up measure to the results of the safety review conducted after the MFDS distributed the drug dear healthcare professional letter in September last year, and plans to order the permission to be changed in July. The MFDS received advice from the Central Pharmaceutical Affairs Review Committee and the Professional Association after a post-marketing survey of Tofacitinib and Baricitinib drugs conducted in the U.S. and Europe, and reviewed the results of a recent domestic anomaly analysis. Detailed permission changes (drafts) can be found at nedrug.mfds.go.kr.
- Policy
- The KDCA is pushing for the introduction of Tecovirimat
- by Lee, Jeong-Hwan Jun 20, 2022 06:02am
- The KDCA announced on the 14th that it will hold a joint meeting of related ministries to introduce 500 people of the antiviral drug Tecovirimat in July to respond to monkeypox. Kwon Joon-wook, head of the National Institute of Health, made this announcement at a briefing on COVID-19. The KDCA plans to hold a meeting of the monkeypox task force jointly with related ministries later in the day. The meeting will discuss detailed plans to introduce 500 antiviral drugs to Korea in July compared to monkeypox. The antiviral drug to be introduced is Tecovirimat, the only product licensed as a monkeypox treatment overseas. Specifically, the product name Tpoxx (Tecovirimat), has been officially approved by the US FDA, Europe EMA, and Canada. Although it is a relatively high-priced drug, the need to secure Korea is also being raised due to mass stockpiling overseas. In the future, if a monkeypox patient occurs in Korea, the patient will be treated in isolation at the National Medical Center until the point of loss of infectious power. Contacts are classified in three stages, and the KDCA is considering quarantining high-risk contacts for 21 days.
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 16, 2022 05:58am
- It was confirmed that the opinions of the Central Pharmaceutical Affairs Council members were also mixed over the limited use of Janus kinase Inhibitors, which is used as a treatment for inflammatory diseases. The MFDS announced on the 15th that high-risk patients aged 65 or older, high-risk cardiovascular groups, and malignant tumors will be able to use them only when they are insufficient with existing treatments. 65 items of JAK inhibitors (Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib) were licensed in Korea. According to the minutes of the Central Pharmaceutical Affairs Council held last month, the committee members gathered opinions on the current status of foreign countries, related studies, and the need to manage JAK inhibitors. As a result, there were three members who did not need to change their efficacy, and only one member said that the effectiveness of all JAK inhibitors needed to be changed. Seven members agreed to change the efficacy effect of Tofacitinib and Baricitinib, which have clear grounds in the United States and Europe. However, it was pointed out by the chairman that if the efficacy is changed only for Tofacitinib and Baricitinib, the prescriptions for other ingredients of the same indication, such as Upacitinib and Filgotinib, are expected to increase at the clinics. It is due to concerns that measures to change the effectiveness of obtaining sufficient data on side effects by obtaining permission first could instill a perception that other ingredients approved late are safer ingredients. "Considering various issues, further discussions are needed on the range of ingredients that change efficacy, such as the application of all JAK inhibitors or two ingredients," the chairman said. A member of the committee said, "It is said to be the same category, but it is known that the mechanism of action is slightly different," adding, "It would be good to maintain restrictions on efficacy based on the evidence so far and apply precautions for use to all drugs." The MFDS said, "We will push for a change in usage precautions that describe major cardiovascular risks for all JAK inhibitors." The MFDS added, "We will change the permission for Tofacitinib and Baricitinib in consideration of confusion from clinics, but we will take further measures to include the remaining three ingredients." Meanwhile, after distributing dear healthcare professional letter in September last year, the MFDS confirmed that patients with cardiovascular risk factors administered Tofacitinib and Baricitinib increased their risk of cardiovascular abnormalities compared to the TNF inhibitor group. The United States restricts all JAK inhibitors to use only in patients who do not respond appropriately to other treatments, such as one or more TNF inhibitors, as well as in high-risk patients. For Tofacitinib, Europe restricts the use of high-risk groups only when there is no appropriate treatment alternative, and considers the need for additional measures for other JAK inhibitors. The MFDS plans to order the change of permission in July through procedures such as inquiry of permission change (proposal) opinion and advance notice.
