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- 2026-06-24 12:06:26
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- Yuhan’s new lung cancer drug Leclaza shows OS benefit
- by Nho, Byung Chul Jun 24, 2022 05:46am
- Yuhan Corp (CEO and President Wook Je Cho) announced on the 23rd that it had confirmed the overall survival (OS) benefit of Leclaza (lasertinib) in the Phase I/II LASER201 trial (NCT03046992). Leclaza is a treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Leclaza is a third-generation oral EGFR Tyrosine Kinase Inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation. The drug showed superior efficacy and safety in NSCLC patients with brain metastasis as it can pass through the blood-brain-barrier (BBB). Lecalza’s OS results had been presented at the AOS 2022 & KCA Annual Meeting 2022 which was held from the 16th to 18th of this month. The OS results were updated from the Phase I/II LASER201 trial that had been the basis for Leclaza’s approval in Korea. The Phase I/II trial evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI at 17 centers in Korea. Analysis results on the 76 patients with EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “It is encouraging that the mOS of EGFR T790M mutation-positive patients who are at high risk of brain metastasis had reached 38.9 months in the study, showing over 3 years of survival. Also, Leclaza is associated with the superior effect of achieving median intracranial progression-free survival (mPFS) of 26 months in patients with measurable brain lesions (25 patients).” Han added, “When considering that the ultimate treatment goal of treating cancer patients is in extending life, the OS benefit identified in the trial shows potential to extend life expectancy in T790M mutation-positive patients.” Meanwhile, the latest results of the Phase I/II LASER201 trial had previously been published in the April edition of the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC). Yeol-Hong Kim, Professor of Hemato Oncology at Korea University Anam Hospital, who is also the President of the Asian Oncology Society, said, “It is meaningful that Leclaza’s OS benefit had been presented at the AOS 2022 & KCA Annual Meeting 2022. The fact that Leclaza, a novel homegrown lung cancer drug, has demonstrated an mOS of 38.9 months in the second-line treatment of EGFR mutation-positive NSCLC is remarkable. The results show the possibility that Leclaza could bring a new turning point to the lung cancer treatment landscape in the future.” Wook Je Cho, CEO of Yuhan Corp, said, “We are pleased to share the news that Leclaza showed an OS benefit that meets the expectations as a novel homegrown lung cancer drug. Yuhan Corp will continue to make efforts, including completing the ongoing clinical trials and global commercialization so that Leclaza can become a useful treatment option for patients suffering from EGFR mutation-positive NSCLC in Korea and around the globe. Meanwhile, Yuhan is currently conducting a multinational Phase III trial (LASER 301) to evaluate the efficacy and safety of Leclaza as a first-line treatment in patients with EGFR mutation-positive NSCLC, and the top-line results of the Phase III trial are expected to be disclosed by the end of this year. A global Phase III trial on the combination of Leclaza with amivantamab, Janssen’s fully human bispecific antibody targeting both EGFR and MET, is also in progress.
- Company
- LG Chem’s Zemiglo+Forxiga combo Zemidapa is approved
- by Chon, Seung-Hyun Jun 23, 2022 05:50am
- LG Chem made a public announcement on the 22nd that the company had received marketing authorization for its type 2 diabetes treatment ‘Zemidapa Tab’ from the Ministry of Food and Drug Safety. The drug is a fixed-dose combination of the antidiabetic drug gemigliptin and dapagliflozin. Gemigliptin is an active ingredient of "Zemiglo," a new DPP-4 inhibitor antidiabetic that was developed by LG Chem. Dapagliflozin is the generic name of AstraZeneca’s SLGT-2 inhibitor, "Forxiga." Zemidapa is the third combination drug made using Zemiglo. LG Chem also owns two other drugs, including ‘Zemimet’ which combines Zemiglo with the antidiabetic drug metformin, and ‘Zemiro’ which combines Zemiglo with the hyperlipidemia drug rosuvastatin, in the market. LG Chem said, “We expect to continue on our current leadership in the diabetes treatment market in Korea with the development of a gemigliptin and dapagliflozin combination that improves the convenience and medication compliance of patients who used to take the two drugs separately as a combination therapy.”
- Company
- Hyundai Introduces Estrogen-Free Contraceptives
- by Jun 23, 2022 05:50am
- Hyundai Pharmaceutical (CEO Lee Sang-joon) announced on the 21st that it has signed an exclusive license agreement with Asuka Pharmaceutical in Korea for the oral contraceptive Slinda"with Drospirenone only. Slinda is a product developed by Exeltis, a women's medical brand division in Insud Pharma, Spain. Unlike the existing fourth-generation complex oral contraceptives, they do not contain Estrogen, so there is less concern about related side effects. Slinda is licensed to sell in the United States and Europe, and Aska has development rights in Korea and Japan. Under this contract, Hyundai Pharmaceutical will have the right to exclusive development and commercialization of Slinda in Korea. An official from Hyundai Pharmaceutical said, "We expect the addition of Slinda to further solidify its position in the domestic contraceptive market."
- Company
- The third challenge of Imbruvica's primary therapy
- by Eo, Yun-Ho Jun 22, 2022 05:59am
- BTK inhibitor Imbruvica will take on its third challenge to expand insurance benefits. According to related industries, the first-line therapy indication of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in Imbruvica will be presented again to the HIRA Cancer Disease Review Committee on the 29th. Imbruvica's first-line therapy indication failed to cross the threshold of cancer screening in two challenges, including October last year. Through the PE special system, the benefit was expanded to secondary therapy after registration, but it seems to have faced difficulties in primary therapy. As a result, it remains to be seen what kind of adjustment Janssen will have to discuss expanding benefits. Imbruvica is the first oral BTK (Bruton's Tyrosine Kinase) inhibitor developed once a day, suggesting the advantage of outpatient treatment unlike existing treatments. In Korea, since it was registered in April 2018, it has been prescribed for the second round of ▲ recurrent and refractory chronic lymphocytic leukemia. In addition, it has ▲ indications of Gazyva combination therapy in patients with chronic lymphocytic leukemia who are 65 years of age or older or have a comorbid disease or have a high risk of being treated before, and ▲ treated for chronic lymphocytic leukemia patients who have comorbid diseases over the age of 65 and have never been treated before. Imbruvica proved its survival benefits in CLL patients as a first-line monotherapy through phase 3 studies 'RESONATETM' and 'RESONATETM-2'. All three clinical trials were sponsored by NCI under NIH, and 354 patients with no previous anticancer treatment experience under the average age of 70 were registered in the clinical trial. As a result of 48 months of follow-up observation, 73% of the Imbruvica combined patients continued the Imbruvica treatment for 43 months. In particular, in the Imbruvica combination group, the risk related to PFS was reduced by 61% compared to the current chemotherapy, and the risk was significantly reduced by 66% in OS benefits.
- Company
- K-botulinum products are expanding globally
- by Jun 22, 2022 05:59am
- Hugel Botulex (Letybo) Domestic botulinum toxin is entering various parts of the world. Feeling limited in the domestic market, developers are targeting the U.S., Europe, and China, which are the largest markets in the world, while expanding their scope to countries such as Australia and the Middle East. ◆ Hugel is targeting Europe and North America, and China is expanding its market According to the pharmaceutical industry on the 20th, Hugel won the license for the botulinum toxin drug Letybo developed in Canada on the 16th. It is Hugel's first North American entry. According to Hugel, the Canadian botulinum toxin market is estimated to be worth 180 billion won as of last year. Starting with Southeast Asia, Hugel has attempted to enter Botulinum overseas in earnestly. It is understood that the license registration has been completed in about 40 countries so far. Last year, it applied for permission for Botulinum in the U.S. and Canada to target North America. In particular, the United States is one of the largest botulinum toxin markets worth about 2 trillion won. The U.S. approval, which was originally expected to be approved at the end of March, is expected to take place at the end of this year or early next year. Starting in February, news of Letybo continued in Europe, starting with France. In January, HMA issued a permit recommendation for botulinum. The HMA receives individual decisions in each country after the recommendation for approval, so the date of approval varies. Letybo has obtained product permits from 10 countries, including key European countries such as France, the United Kingdom, Germany, and Italy. ◆Daewoong Nabota Launches Third Quarter in Europe. U.S. Sales Close to 300 Billion Daewoong Pharmaceutical's botulinum toxin drug Nabota is doing good performance in the North American market, which was the first to enter. Nabota posted nearly $100 million in sales last year, up 77.3% from the previous year. This is the result of the North American sales of Daewoong Pharmaceutical's U.S. partner Evolus. Nabota's cumulative sales, which were approved by the U.S. in February 2019, amounted to $223.04 million. In the first quarter of this year, Nabota has continued its upward trend, recording $33.23 million (42.5 billion won), up 171.5% from the previous year. Nabota In the third quarter, Nabota is also set to enter Europe, the second largest market in the world. Evolus, a U.S. partner, will be in charge of sales. Previously, Evolus obtained an item license from the European Commission (EC) in October 2019 under the name Nuceiva. Nuceiva can be sold in 28 countries in the European Union and a total of 31 European countries, including the UK and Switzerland. Daewoong Pharmaceutical recently expanded its scope to Eastern Europe and the Middle East. It has obtained Nabota permission from Saudi Arabia, one of the largest markets in the Middle East, and Ukraine, the representative country of Eastern Europe. Its goal is to expand its market share in the Middle East and Eastern Europe starting with Saudi Arabia and Ukraine. In December last year, Daewoong Pharmaceutical filed an application for permission for Nabota with the NMPA. While Hugel and Daewoong Pharmaceutical are expanding their market to one item developed by themselves, Medy Tox is trying to diversify its products. It was the first in Korea to commercialize botulinum toxin preparations and enter the development of next-generation toxin preparations early. Meditoxin is exported to more than 30 countries around the world under the name Neuronox. However, exports have been decreasing every year since 2019. Overseas exports of Medy Tox, which were 133.3 billion won (including filler products) in 2018, decreased to 120.6 billion won in 2019 and 89.8 billion won in 2020. It recorded 70.6 billion won last year. Neuronox Newlux, which applied for item permission from the MFDS in May, is a new product that Medy Tox applied the latest process to reduce the possibility of contamination by impurities. Medy Tox is also speeding up its overseas licensing work for Newlux exports.
- Company
- Takeda Korea appoints Sun Jin Lee as head of Oncology BU
- by Jun 21, 2022 05:54am
- Sun Jin (Justine) Lee, New Head of Oncology BU, Takeda Pharmaceuticals Korea Takeda Pharmaceuticals Korea (General Manager HeeSeok Moon) announced on the 20th that it had promoted and appointed Manager Sun Jin (Justine) Lee as the Head of its Oncology BU. The new head, Lee, who joined Takeda Pharmaceuticals Korea as a marketing manager of the Hemophilia BU, developed creative marketing strategies and drew participation from internal and external stakeholders for its implementation. Lee played a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business and demonstrated her leadership capabilities. In recognition of her leadership, Lee had led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC) region, and also successfully carried out projects such as presenting the vision and direction for the digital transformation of Takeda in the APAC region. it was recognized for its leadership capabilities, such as playing a pivotal role in improving the access and awareness of Takeda Korea's hemophilia business. Since then, he has led the product launch in the market as a Launch & Digital Excellence Lead in the Asia Pacific (APAC), and at the same time ha Junghun Kim, the former head of the Oncology BU, has been appointed Country Manager of Malaysia & Singapore in May through the 'FLP(Future Leaders Program)' that provides global networking opportunities for employees within Takeda Pharmaceutical. Kim joined Takeda Pharmaceuticals Korea as a marketing manager in 2015 and established the Inflammatory bowel disease and blood cancer BU. After being appointed head of the Oncology BU in 2019, Lee launched various innovative oncology products in Korea and exceeded the target for three consecutive years, and has been leading the company’s digital transformation in Korea. Under the value ‘Exceptional People Experience,’ Takeda Pharmaceuticals is committed to providing various experiences and opportunities for its employees to develop their capabilities. It also offers special programs for select key talents. The ‘FLP (Future Leaders Program)’, which provides global networking opportunities in Takeda, is one such program, and the recent personnel appointments were also made through the FLP. HeeSeok Moon, General Manager of Takeda Pharmaceuticals Korea, said, “The promotion has more meaning as it was achieved by Takeda’s professional development program. Takeda Pharmaceuticals Korea will continue its best efforts to support various programs for our executives and employees to develop their careers so that each and every employee may realize his or her full potential.”
- Company
- KIMS has signed a license agreement for Lipothasone
- by Nho, Byung Chul Jun 21, 2022 05:54am
- KIMS Pharmaceutical announced on the 20th that it has signed a contract with Japanese pharmaceutical company Mitsubishi Tanabe Pharma on the 17th to license Lipothasone. Through this contract, KIMS Pharmaceutical will officially release the product in August. According to KIMS Pharmaceutical, Lipothasone is the only Dexamethasone in Korea that uses Mitsubishi Tanabe Pharma's Lipid Nano Particle (LNP) technology. Steroids are excellent enough to be called panacea, but it is a drug that is reluctant to be prescribed due to serious side effects. Lipothasone is known to be a strong and safe anti-inflammatory treatment as well as targeted treatment of inflammatory areas by reducing the side effects of existing steroid injections, allowing IV, Epidural, and Intrathecal. In addition, this product is a drug carrier liposome (liposomalization) using DDS (Drug Delivery System) technology, and is considered to be a product that minimizes drug effect loss and minimizes side effects by selectively expressing effects on target lesions. Kim Seung-hyun, CEO of KIMS Pharmaceutical, said, "We are happy to have LNPS drugs through this contract." "We will continue to strengthen cooperation with Mitsubishi Tanabe Pharma Korea to promote mutual development and do our best to secure patients' access to new drugs," he said. KIMS Pharmaceutical is a company recognized for INNOBIZ, COVA, MAINBIZ, and HBA, and has a corporate research institute and a GMP plant in Osong, Chungcheongbuk-do.
- Company
- 11 of the national essential drugs are non reimbursed
- by Eo, Yun-Ho Jun 20, 2022 06:04am
- It was found that 11 of the drugs designated by The National Essential Medicine, excluding vaccines, are still non-reimbursed. As of December 31, 2021, 511 species have been designated as the National Essential Medicine, and 158 types of infectious disease-related drugs excluding vaccines. Of these, 11 drugs were not on the insurance benefit list. However, Remdesivir, a treatment for COVID-19, is not reimbursed, but the government pays the full cost of the drug. The national essential medicine refers to medicines that must be prepared in the country for national health, and was first discussed and introduced by the World Health Organization. Through the pandemic of infectious diseases such as MERS and COVID-19, securing stable national essential drugs such as vaccines and treatments for preventing infectious diseases is recognized as the core of national security and national competitiveness. However, it is pointed out that the problem of accessibility of the National Essential Medicine is still a blind spot. In fact, the National Health and Welfare Committee's parliamentary audit last year raised questions about the suspension of the supply of The National Essential Medicine and the low health insurance benefit registration rate. Non-payment drugs include Ceftolozane/Tazobactam injections (Zerbaxa), Isabuconazonium sulfate (Cresemba), Baloxavir (Xofluza), which had many clinical demands. Zerbaxa is an antimicrobial drug that was expected to be introduced in Korea as a new treatment alternative to Carbapenem, which was approved in Korea in April 2017 as an indication of complex urinary tract infection and complex intraperitoneal infection by effective strains in adult patients. Carbapenem-resistant-P. aeruginosa is one of the top-priority pathogens that require research and development of new antibiotics. Although Zerbaxa is an effective treatment for resistant bacteria that is not effective for Meropenem, it has been restricted from using Meropenem as an alternative and failed the benefit list despite high demand, but its appropriateness was recognized at the 6th Pharmaceutical Benefit Evaluation Committee held on the 2nd. Cresemba is an antifungal drug that was licensed and non-reimbursed in Korea in January 2020 for invasive aspergillosis and mucormycosis. Like Zerbaxa, it is blocked by PE, which has to prove cost-effectiveness by comparing old drugs with alternatives, and despite the occurrence of COVID-19-related inert aspergillosis in Korea, it is currently non-reimbursed. Invasive aspergillosis is one of the three major invasive fungi threatening humans, which occur in patients with reduced immunity, and is one of the causes of death in immunodeficiency patients due to the recent increase in chemotherapy or AIDS patients in Korea. The flu treatment Xofluza was a new drug that was expected to replace Tamiflu and was approved in Korea in November 2019, just before the COVID-19 pandemic. Since receiving conditional non-reimbursement from the Drug Benefit Evaluation Committee in October 2020, there has been no update yet. The experience of the COVID-19 pandemic has raised awareness of the rapid response of infectious diseases and the importance of drugs in policy and society, while access to infectious diseases, especially new drugs, remains before the pandemic. Since drugs related to severe infectious diseases such as multidrug-resistant infections and invasive fungal infections are used in emergency situations, it is essential to secure various types of drugs so that they can be used immediately if necessary. Choo Eun-joo, director of KSID's Insurance dept. (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University), said, "There are no antibacterial and antifungal drugs that have been reimbursed for the past five to seven years. As drugs necessary for the treatment of fatal infectious diseases play a key role not only in the survival of individual patients but also in preventing the spread of infectious diseases, they should not be evaluated only from an economic perspective, she said.
- Company
- 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.
- 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."
