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- 2026-03-17 00:55:07
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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.
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- 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."
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- 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.
- Company
- GC Pharma leads 300 billion flu vaccine market
- by Nho, Byung Chul Jun 15, 2022 07:48pm
- SK Chemicals and GC Pharma are competing in the private 4-valent influenza (flu) vaccine market with an external banding of 200 billion won, the survey showed. SK Chemical's SKY Cellflu Quardrient and GC Flu Quardrient ranked first and second in the private distribution flu vaccine for the past three years (2018, 2019, 2020), with performances of "11.3 billion won, 13.1 billion won, and 63.8 billion won," "7.7 billion won, 12.4 billion won, and 51.5 billion won," respectively. However, in the case of last year, it is difficult to compare sales absolutely because SK Chemical placed seasonal flu production as a subordinate priority due to CMO issues of the COVID-19 vaccine. The growth of Boryung Biopharma FluV Tetra and Flu8 Tetra is also noteworthy. The total performance of the two products in 2018, 2019, 2020, and 2021 is 6.3 billion won, 7.1 billion won, 37.9 billion won, and 34.4 billion won, securing the third place. Ilyang's Teratect rose sharply from 970 million won in 2018 to 20.4 billion won in 2021, and the Korean vaccine Kovax flu quadrivalent also achieved a quantum jump in sales from 990 million won to 13.2 billion won during the same period. The overall performance increase of flu vaccine products can be attributed to temporary strategic production issues of SKY Cellflu quardrient, increased demand due to twin-demic concerns, and cold chain issues in 2020. Among foreign companies, Sanofi's Vaxigriptetra and GSK's Fluarix Tetra are supplied to the private sector. Vaxigcriptetra's sales were 4.4 billion won, 4.6 billion won, 12.7billion won, and 13 billion won while Fluarix Tetra's sales were 11.6 billion won, 7.8 billion won, 13.6 billion won, and 5.1 billion won. The size of the trivalent flu vaccine market has been reduced from 53.3 billion won in 2019 to 1.9 billion won in 2021. GC Pharma's trivalent flu vaccine GC Flu also posted sales of 12.4 billion won in 2018, but it has reduced its portion to 8 million won in 1Q in 2022 and is focusing its efforts on the quardrivalent vaccine. What should be noted is the opening of the quardrivalent vaccine era, and LG Chem has no sales of its only three-valent flu vaccine, Flu Plus TF. This product showed a performance of between 2 billion won and 5.6 billion won between 2018 and 2019, but it was the last time it sold 400 million won in 2020. In the bidding market for influenza vaccines between 2022 and 2023, Korea Vaccine and Boryung Biopharma, which bid 10,433 won(2.2 million doses), 10,670 won and 10,687 won respectively, will supply 1.7 million to 1.8 million doses to the KCDA. GC Pharma (6 million doses) and Ilyang Pharmaceutical (1.9 million doses) offered 10,700 won in the same bid. Ilyang Pharmaceutical fell from the KCDA's bid due to a bidding rule that selects companies with large quantities at the same price. Regarding the supply and demand of the flu vaccine in the open bidding market for the Nara Market of the Public Procurement Service, the KCDA amount is about 11 million doses, which is about 90 billion won in amount. The NIP market is formed in the range of 7,000 won to 10,000 won, which is lower than the private supply price, making it difficult for pharmaceutical companies to secure margins, raising public opinion on the realization of bidding prices. The flu vaccine vaccination price, which is supplied to the private sector, is around 20,000 won to 45,000 won, and the vaccination rate is increasing through various events. In the case of clinic A, it is promoting that the price has been reduced from 35,000 won to 27,000 won for a single vaccination of tetravalent influenza vaccine. The tetravalent influenza vaccine + shingles vaccine is discounted from 205,000 won to 180,000 won, and the tetravalent influenza vaccine + pneumococcal vaccine is discounted from 165,000 won to 140,000 won. Regarding the overall situation, Pharmaceutical B said, "It is also unusual that some companies are not very interested in NIP open competitive bidding due to the mismatch of realistic procurement prices in the vaccine bidding market." An employee of this pharmaceutical company said, "We are focusing our production and marketing capabilities on private supplies with a relatively high margin." The procurement agency's bidding has been held by wholesalers, a distributor, but it has been directly participating in the manufacturing and import mission since last year due to the issue of exposure to room temperature of the flu vaccine in 2020.
- Company
- Samsung Bioepis Announces Phase 3 Results of Soliris Similar
- by Kim, Jin-Gu Jun 15, 2022 05:50am
- Samsung Bioepis announced on the 13th that it has unveiled the results of phase 3 clinical trials of Soliris (Eculizumab) biosimilar SB12 through the EHA annual academic conference held in Austria from the 9th to the 12th. SB12 is the seventh biosimilar developed by Samsung Bioepis. It is the first blood disease treatment. The original Soliris is a treatment for incurable rare diseases such as PNH and aHUS developed by Alexion in the U.S. Last year, global sales amounted to $1.874 billion (approximately 2.3 trillion won). Samsung Bioepis conducted a comparative study between SB12 and the original (ECU) in PNH patients from July 2019 to October 2021. At this conference, the results were announced in the form of an e-poster. Samsung Bioepis conducted clinical trials by comparing and evaluating efficacy, safety, pharmacology, and immunogenicity between the two products. Among PNH patients who were first prescribed drugs, 50 patients aged 18 or older whose LDH level was measured to be 1.5 times or more of the normal ULN were randomly assigned. Samsung Bioepis administered SB12 or original every week for the first four weeks, 900 mg at the fifth week, and 900 mg every two weeks during the subsequent maintenance period. It then conducted research until 50 weeks while switching the two products at the 26th week. The primary efficacy evaluation index for this clinical trial was set as the "LDH level at the 26th week of drug administration" and the "AUEC (Area Under Effect Curve) of the time-adjusted LDH from 14th to 26th weeks and 40th to 52nd weeks. As a result of the study, 46 out of 50 patients completed clinical trials, and the primary efficacy evaluation index met the predefined clinical equivalence range. The difference in mean LDH values at week 26 (SB12-ECU=34.48) between SB12 and the original drug was found to have a 95% confidence interval (-47.66, 116.62) in the predefined equivalence range. For SB12/ECU: 1.08) between SB12 and the original drug, it was included in the predefined equivalence range in the 90% confidence interval (0.95, 1.23). Similar results were found in the LDH values for the entire clinical trial period, one of the secondary efficacy evaluation indicators. For TEAs, SB12 was 72.3% and original drugs were 68.1%. All three serious post-treatment adverse events in SB12 prescribed patients were unrelated to treatment. Oh Yoon-seok, executive director of PE (Product Evaluation), the clinical director of Samsung Bioepis, said, "SB12 is a product that has the essential meaning of biosimilar development to improve patient accessibility of ultra-high-priced bio-medicine." He said, "We confirmed safety and efficacy compared to original drugs through clinical trials." Soliris is an expensive biopharmaceutical that costs hundreds of millions of won a year for adult-based medication, and Samsung Bioepis provides SB12 free of charge for up to two years to domestic and foreign patients who participate in clinical trials.
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- Sales of topical minoxidil rise with interest in hair loss
- by Jun 14, 2022 06:04am
- (From the left) Rogaine, Mynoxyl, Dongsung Minoxidil The market for minoxidil topical solutions that are applied directly to the scalp continued on its strong growth, with marked growth shown by the foam-type Rogaine Foam among the three major products in the market. According to the market research institution IQVIA on the 14th, the minoxidil topical solution market had raised ₩4.6 billion in 4 months from January to April this year, a 36% YoY increase from the ₩3.4 billion made in the same period last year. The minoxidil market expanded rapidly with the rise in younger hair loss patients and the increasing perception that the condition needs to be managed in its early stages. Minoxidil, a topical medication that is directly applied to the scalp, expands the blood vessels to facilitate a smoother supply of nutrients to the hair. The market size, which had been below ₩1 billion from January to August last year, has increased to ₩1.5 billion this year along with the rising interest in hair loss. The total sales of minoxidil products in the market last year amounted to ₩12.5 billion, a 22% increase from the ₩10.2 billion of the previous year. Three products – Hyundai Pharm’s Minoxyl., Johnson&Johnson’s Rogaine Foam, and Dongsung Minoxidil – are leading the minoxidil topical solutions market. Among the three drugs, Hyundai Pharm’s Minoxyl has a 33% share of the market, followed by Dongsung Minoxidil (25%), then Rogaine Foam(24%). Recently, Rogaine Foam has been making the most marked growth. Rogaine Foam, which was released in 2017, has only accounted for 15% of the total market, bringing in an annual sales of ₩1.6 billion in 2020. However, its sales rose 89% last year to record ₩3 billion. Its market share had also grown 9%p to reach 24%. After chasing the runner-up Dongsung Minoxidil to the brim last year, Rogaine Foam beat Dongsung Minoxidil this year and took second place in the market. Its cumulative sales by April this year were ₩1.4 billion, a 119% increase YoY. Rogaine Foam’s market share had even exceeded that of the market leader Minoxyl in April this year. Rogaine Foam currently occupies 30% of the market, just a 1%p difference from the No.1 leader Minoxyl. This year’s market growth is analyzed to have been driven by Rogaine Foam. Sales of Minoxyl and Dongsung Minoxidil have also increased, but only by 18% and 12% each. By April, cumulative sales made by Minoxyl amounted to ₩1.4 billion, and Dongsung Minoxidil to ₩1 billion. Rogaine Foam’s contribution to the growth of the minoxidil topical solution market was 61% this year. It is interpreted that Rogaine’s foam type made this success by differentiating itself from the existing liquid-type products. As Korea’s first foam-type hair loss treatment, it minimized the dripping and stickiness associated with the gel-type formulation. Also, it does not contain propylene glycol (PG), which can cause skin irritation such as itching and stinging. In fact, a consumer survey on hair loss patients that was conducted by Johnson&Johnson shows that people who purchased Rogaine Foam selected its convenience in use and verified effect as the product’s top strengths. Also, the company believes its marketing campaign that related well to the minds of its consumers had brought a synergistic effect along with its product power. Junghwa Cha, brand manager at Johnson & Johnson Korea, said, “Our original foam type minoxidil topical solution shows the optimal effect when used in combination with oral finasteride, and is therefore commonly prescribed by specialists at hair loss clinics. Our efforts to highlight the product’s efficacy and effect while preparing a solid ecosystem so that consumers can appreciate the value of Rogaine Foam from every aspect, in addition to the support shown by pharmacists in the field, have driven the rapid growth of the product this year."
- Company
- Lilly Korea has entered into negotiations on Emgality
- by Eo, Yun-Ho Jun 14, 2022 06:04am
- CGRP target migraine drug Emgality is in the final stage for insurance benefit registration. According to related industries, Emgality, a target migraine treatment for CGRP (Calcitoninogen-related peptide) by Lilly Korea, recently began negotiations with the NHIS on drug prices. Considering the deadline for negotiations, a conclusion is expected within next month. If Emgality is reimbursed, it will be the first new drug in the system. Emgality passed the Drug Reimbursment Evaluation Committee on the 12th of last month after submitting a benefit application in March 2021. Handok Teva's Ajovy, which is currently a competitive drug, is also in the process of registration. These drugs are humanized monoclonal antibody drugs that bind to CGRP molecules that play a major role in causing migraine symptoms to block binding to receptors. Although the two drugs are of the same series, there are differences in doses, so patients with severe migraine are approaching with another expectation. Emgality was based on the EVOLVE-1 and EVOLVE-2 studies in which 1773 Episodic Migrain patients (4-14 days per month) participated for 6 months, and the REGAIN study in which 1,113 patients (15 days per month) participated in the average headache and 8 days or more. In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of days of migraines per month for six months in the Emgality group (226 patients) decreased by two more days compared to the placebo group (450 patients) (4.3 days in the Emgality group and 2.3 days in the placebo group), the number of patients administered by Emgality, whose number of migraine days decreased by 50% over 6 months, was 59% (36% in the placebo group), 34% (18% in the placebo group) which decreased by more than 75%, and patients who decreased by 100% were 12% (6% of placebo group). Min Ju-kyung, a neurology professor at Sinchon Severance Hospital, said, "Migrain headaches are more painful than imagined and hinder the quality of life of patients. Patients who experience migraines more than 4 to 5 days a month can expect to improve their quality of life through preventive treatment," she explained.
- Company
- Whether Gardasil 9's supply price increase is reasonable
- by Jun 14, 2022 06:04am
- In order to improve the accessibility of vaccines monopolized by foreign companies, it was suggested that reasonable pricing should be monitored and institutional support measures for self-reliance should be actively reviewed. The Korea Biotechnology Industry Organization Bioeconomic Research Center said in a report titled "Controversy over domestic drug price hikes through cervical cancer vaccines" on the 13th, "Medicine prices should be reasonably priced in the drug market and should be monitored and improved if there is a competition restriction." The start is an increase in the supply of Gardasil 9, a cervical cancer vaccine for MSD. MSD raised its supply price by 25% in two years. Following the 15% increase in April last year, it decided to raise an additional 8.5 percent this year. It will be supplied at 132,636 won (excluding VAT) from July 1st. The Center for Biological Research questioned the additional increase in Gardasil 9 in MSD. "The price of drugs is set according to the logic of negotiation or free market competition with health authorities, reflecting the high failure rate, long development period, market size, and competition when developing new drugs. Excessive external intervention in the price of new drugs can hinder innovation. The center pointed out, "However, if the market dominance of certain drugs is large and the price continues to rise, the cause should be identified." In fact, Gardasil 9 accounts for 76% of the total market in the domestic cervical cancer vaccine market. There are only three types of cervical cancer vaccines: Gardasil, Gardasil 9, and Cervarix. All of them were developed by overseas pharmaceutical companies, and Gardasil 9, the latest of them, is dominating the market. Gardasil 9 prevents nine of the HPV serotypes that cause cervical cancer. The center then said, "Multinational pharmaceutical companies are emphasizing through ESG reports that they are working to expand access to medicines. MSD also said it has a role and responsibility to help improve access to medicines and vaccines around the world with the aim of sustainable development, pointing out that MSD's increase in supply of Gardasil 9 does not meet the company's goals. According to the MFDS, Gardasil 4 was also included in products that did not release generics even after patent rights expired among items with import performance of more than $10 million. The center stressed, "As the importance of health and security increases due to COVID-19, institutional support measures that can promote self-reliance in Korea should be actively reviewed if domestic development is sluggish."
