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- 2026-04-07 22:25:29
- InterView
- 1 year after Lynparza approved for early-stage breast cancer
- by Son, Hyung-Min May 07, 2024 05:50am
- Professor Min Hwan Kim, Department of Oncology at Severance Yonsei Cancer Hospital. It’s been over a year since Lynparza was approved for the treatment of early-stage breast cancer. Previously, Lynparza was mainly used for treating metastatic breast cancer, but it expanded its usage following the approval last year for the early-stage treatment. As Lynparza has been confirmed to have a superior drug tolerance in the real-world, experts are advocating its use at early stages to prevent cancer recurrences. During a meeting with Daily Pharm, Professor Min Hwan Kim, Department of Oncology at Severance Yonsei Cancer Hospital, shared an opinion that Lynparza should be used more in early-stage treatments. Recently, targeted cancer therapies have proven their treatment effects at early stages in the field of solid cancer, including lung cancer, breast cancer, and gastric cancer. Lynparza is one of them. Lynparza is a PARP inhibitor-class therapy developed by AstraZeneca. It was approved in 2019 as a treatment for patients with metastatic HER2-negative breast cancer who carry germline BRCA (gBRCA). The PARP1 protein has been known to be overexpressed in female cancers, such as breast cancer and ovarian cancer. Lynparza’s underlying mechanism of action is preventing PARP1 from DNA binding, thereby inhibiting further cancer progression. Previously, patients with metastatic HER2-negative breast cancer and gBRCA mutation had unmet needs in targeted therapy options. Then, PARP inhibitor, which has shown effects in gBRCA metastatic ovarian cancer, emerged as a new treatment option as it demonstrated effects in breast cancer. Furthermore, in February of last year, Lynparza expanded efficacy in treating high-risk patients with metastatic HER2-negative breast cancer and gBRCA mutation. Kim emphasized the use of Lynparza at an early stage to prevent recurrence and for breast cancer patients to return to daily life. Lynparza demonstrated effects in early-stage breast cancer patients gBRCA mutations has been pointed out as the key risk factor for breast cancer. Mutation in gBRCA complicates the DNA damage repairs. In this case, genetic changes in a normal cell can lead to cancer occurrence. Mutations in gBRCA are found in around 5-10% of the total breast cancer. Whereas the average age of diagnosis for breast cancer is 63, the average age of diagnosis is relatively early when there is a BRCA1 mutation, at an average of 44.1, and a BRCA2 mutation, at 45.1. Breast cancer patients with gBRCA mutations confer poor prognosis, and as for HER2-negative breast cancer, there is no targeted receptor, which puts patients in limited treatment circumstances. But a relief for such individuals suffering from this condition is that PARP inhibitors, which have been found effective in treating breast cancer with gBRCA mutations, are now available. Lynparza, in particular, is expanding its presence after having demonstrated its effectiveness in the Phase 3 OlmpiA clinical trial, which involved HER2-negative breast cancer patients at early stages who carry gBRCA1/2 mutations. The clinical trial involved 1,836 patients who have completed adjuvant chemotherapy either prior to or after the surgery. During the follow-up period of 3.5 years (median value), post-surgical Lynparza adjuvant therapy reduced breast cancer recurrence or risk of death by 42% compared to placebo. Lynparza group’s invasive disease-free survival (IDFS) at 4 years was 82.7%, which was 75.4% longer than the placebo, and their distant disease-free survival (DDFS) was 86.5%, showing a significant improvement compared to 79.1% in the placebo group. For this reason, Kim strongly voiced his opinion towards the use of anti-cancer agents, such as Lynparza, at early stages of cancer. When cancer relapses, complete recovery cannot be anticipated, and improvements in survival rate are rarely found. Kim said, “When cancer relapses, even if Lynparza is used, complete recovery cannot be expected, and improvements in overall survival rate have not been demonstrated. Therefore, the benefit of using PARP inhibitors at early stages is enormous. Lynparza demonstrated overall survival rate improvements at early stages of HER2-negative breast cancer, increased complete recovery rate, and has solid clinical evidence.” He also emphasized that the “Lynparza group’s distant disease-free survival (DDFS) at four years was 86.5%, which practically lowered the recurrence rate to one-third. The clinical trial involved patients with triple-negative breast cancer, in which case cancer recurrence carries a higher risk of death. Reducing the cancer recurrence for these patients means a lot since it provides life-extension.” Non-reimbursed gBRCA screening…breast cancer patients face greater burden After receiving approval for expanded indications in early-stage breast cancer last year, Lynparza prescriptions are now available for patients. The basis for approval was superior drug tolerance and low side effects in early-stage breast cancer. Kim said, “To date, there have been no patients with cancer recurrence after Lynparza use. We are experiencing that Lynparza proved superior drug tolerance in treatment settings. We initially had concerns about the potential blood diseases, such as leukemia, considering the PARP inhibitor’s characteristics, but the side effects have been generally favorable when prescribed. Additionally, there weren’t many cases of anemia and tiredness.” Until now, the majority of targeted cancer therapies have been administered as non-reimbursed despite being approved for early-stage treatment options in various cancer types. Lynparza is non-reimbursed for use as post-surgical adjuvant therapy. Therefore, Kim emphasizes that early-stage cancers should be treated with targeted therapies more. “Considering the overall medical costs, early-stage treatment is more beneficial. The initial treatment costs about KRW 20 million to 30 million per year. Such treatment lasts about two years, and costs continue to grow when treating beyond the period,” Kim said. “Therefore, in terms of the society, it is important to prevent recurrence and save costs afterward through early-stage treatments,” he added. Kim also emphasized the importance of setting reimbursement criteria for the cost of gBRCA gene screening. Currently, breast cancer patients carrying gBRCA mutations bear a greater burden due to non-reimbursed administration and the cost of gene screening. The current reimbursement criteria for gBRCA screening include △At least one family member or relative (up to third-degree relative) with breast cancer, ovarian cancer, male breast cancer, metastatic prostate cancer, or pancreatic cancer △Been diagnosed with breast cancer at age 40 or younger △Been diagnosed with triple-negative breast cancer, bilateral breast cancer, or breast cancer with concurrent ovarian or pancreatic cancer at age 60 or younger △Male breast cancer and ovarian cancer patients. Kim said, “gBRCA gene screening costs about KRW 20 million when reimbursed, which burdens patients to have it tested without reimbursement coverage. Screening is advised in the United States for those with triple-negative breast cancer, regardless of age. However, Korea’s reimbursement coverage is narrow, leading to missed cases of diagnosing patients with gene mutations.” And added, “Since mutations in gBRCA are found about 10% in patients with hormone-positive breast cancer, we have a higher possibility of missing the detection because they are excluded from the reimbursement coverage for screening.” “Because the breast cancer occurrence rate is high in Korea, and it can be higher, appropriate treatment is critical. In particular, patients’ access to innovative new drugs should be improved,” Kim commented. “In Korea, there are cases of providing patient accessibility by granting selective reimbursement when new cancer drugs are not reimbursed, but almost half of the patients give up on the treatment because of the costs. Therefore, we need a more flexible system,” Kim emphasized.
- Company
- Fate of Retevmo’s reimb in Korea receives attention
- by Eo, Yun-Ho May 03, 2024 06:00am
- No news has been heard of ever since its drug pricing negotiations broke down in August last year. However, RET inhibitors are a hard-to-forego treatment option for a small number of lung cancer patients. There are only 2 RET-targeted therapies – ‘Gavreto (pralsetinib),’ which Roche Korea introduced from Blueprint Medicines, and ‘Retevmo (selpercatinib’ by Lilly Korea – currently approved in Korea. Both drugs have attempted insurance reimbursement in Korea but were denied reimbursement last year. Adding Roche's market withdrawal for Gavreto, it would be hard for Gavreto to be listed for reimbursement in Korea. The case is not much better for Retevmo either. Retevmo, which was approved in Korea in March 2022, failed to pass the Health Insurance Review and Assessment Service Cancer Disease Review Committee (CDDC) review in May of the same year, but then passed the CDDC review in November and finally passed the Drug Reimbursement Evaluation Committee in May last year. After passing the DREC review, the company entered into drug price negotiations with the National Health Insurance Service in June, raising expectations on Retevmo’s reimbursement. However, the two ultimately failed to reach an agreement. In fact, it was the only news of a drug pricing negotiation failure reported in the past year. As a result, it has become unclear whether or not anticancer drugs targeting RET mutations will ever be covered in Korea. However, there has been one glimmer of hope - Phase III results of Retevmo that were released in October last year. Results from Phase III trials on Retevmo - LIBRETTO-431 and LIBRETTO-531 - were presented at the European Society for Medical Oncology Annual Congress (ESMO 2023) last year. The results were published in the internationally recognized New England Journal of Medicine (NEJM) along with the congress presentation. The LIBRETTO-431 trial presented at the meeting compared Retevmo with platinum-based chemotherapy±pembrolizumab as a first-line treatment in patients with advanced or metastatic RET fusion-positive NSCLC. Key findings in the trial showed that in the ITT-pembrolizumab population, the median progression-free survival (PFS) by an independent centralized review committee (BICR) was 24.8 months in the Retevmo arm, and 11.2 months in the control arm, with a hazard ratio of 0.465. The overall response rate (ORR) by BICR was 83.7% in the Retevmo arm, which was statistically significantly higher than the 65.1% in the control arm. Retevmo was granted conditional authorization for conducting a Phase III trial and had trouble during the registration process as the authorities requested the company for data equivalent to a Phase III trial due to its lack of a Phase III trial. This led to criticism about the evaluation criteria for conditionally approved drugs that were granted fast-track review at the time. Retevmo, which applied for fast-track status under the accelerated review system, had been in reimbursement discussions for about a year and a half to no avail. This time, however, the company has secured solid Phase III trial results. Now it remains to be seen whether Lilly will be willing to try again and whether the government will be willing to reimburse the RET inhibitor. In 2020, Retevmo was approved as the first treatment option for cancer patients with RET alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation.
- Policy
- Handok’s imported PNH drug Empaveli is approved in Korea
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) announced on the 29th that it has approved Handok's imported new drug Empaveli Inj (pegcetacoplan). Empaveli binds to complement proteins C3a and C3b and inhibits the complement chain reaction, inhibiting intravascular and extravascular hemolysis. The drug is expected to help expand treatment options for adult patients with paroxysmal nocturnal hemoglobinuria**. The complement system is a part of the body’s innate immune system and helps the body fight off pathogens such as bacteria and viruses. It comprises a large number of different proteins (comprised of C1 through C9) that work together to promote immunity and inflammatory responses. PNH is caused by a somatic mutation in the X-chromosome that makes red blood cells sensitive to the complement response, leading to intravascular and extravascular hemolysis extravasation. Clinically, it manifests as aplastic anemia with decreased hematopoietic stem cells. Symptoms include fatigue, jaundice due to chronic hemolysis, hepatosplenomegaly, hemolytic anemia, hematopoietic deficiency, and venous thrombosis. The MFDS said, "We will continue to make our best efforts to ensure that treatments with sufficiently verified safety and efficacy are promptly supplied based on regulatory science so that patients can gain access to expanded treatment opportunities.”
- Policy
- AZ wins nod for new breast cancer drug 'Tiroo Cap Tab'
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) stated that it has granted AstraZeneca Korea’s new breast cancer drug 'Tiroo Cap Tab (capivasertib)' on April 29th. Capivasertib inhibits the activation of AKT protein, a serine·threonine kinase. Thus, it blocks the intracellular signaling pathway, preventing the survival and proliferation of tumor cells. This drug can be used in combination with fulvestrant in adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced, or metastatic breast cancer who have one or more mutations in PIK3CA/AKT1/PTEN genes during an endocrine therapy or when the disease progresses after completion, or when relapse occurs within 12 months after adjuvant therapy. The MFDS anticipates that this drug will provide a new treatment opportunity for patients with HR-positive, HER2-negative, advanced breast cancer who cannot be treated with existing treatments. The MFDS stated that with their specialty in regulatory science, they are committed to ensuring that treatments with proven safety and effectiveness are promptly distributed to expand patients’ treatment opportunities.
- Product
- The Court rejects petitions on drug pricing negotiations
- by Kang, Shin-Kook May 03, 2024 05:53am
- The Constitutional Court of Korea. The Constitutional Court of Korea (hereafter referred to as the Constitutional Court) made a decision to reject pharmaceutical company’s petition, which alleged a constitutional violation related to the drug pricing negotiations order. The Constitutional Court recently announced that the clause of a claim, including the violation of the constitution, related to drug pricing negotiation does not fall under the category of exercising governmental authority subject to a constitutional petition. As a result, the request for petition has been declared invalid. The clause in dispute was 'Rules on Criteria for the Health Care Benefits of the National Health Insurance Service,' which allows the Minister of the Ministry of Health and Welfare (MOHW) to order the President of the National Health Insurance Service (NHIS) to negotiate with a manufacturer related to a pharmaceutical that already is reimbursable for health care benefits, acts related to the Minister of MOHW ordering President of the NHIS to negotiation with the petitioners, and acts related to the President of the NHIS disclosing negotiations schedule to the petitioners and notifying of submitting required documents. The Constitutional Court stated, "The clause in question is an organizational regulation that merely specifies the Minister of the MOHW to instruct the President of the NHIS to negotiate. Therefore, the rule does not infringe upon the petitioners' fundamental rights." The Constitutional Court ruled that "The Minister of the MOHW issued an internal order directing the President of the NHIS as a supervisory agency. It does not fall under the criteria of exercising governmental authority subject to constitutional appeals." And added, "Moreover, the Court highlighted that the notice does not directly affect the petitioners' rights and obligations. Therefore, historically, it does not qualify as a subject of a constitutional appeal."
- Company
- Roche Korea appoints Ezat Azem as new general manager
- by Son, Hyung-Min May 03, 2024 05:52am
- Ezat Azem, new General Manager, Roche Korea Roche Korea announced that it had appointed Ezat Azem as the new general manager, effective as of May 1. The new GM first joined Roche’s Israel subsidiary in 1997, after which he served nearly 27 years in the group as a marketing division leader in Romania, Slovenia, and other countries around the world, contributing to the launch and growth of the company’s key products. From July 2019 to most recently, Azem has served as General Manager of Roche Greece. Azem was recognized for his excellent people leadership and expertise, particularly for successfully leading the strategic portfolio expansion in the Oncology, Hematology, and Specialty Care business units. In addition, during his service as GM of Roche Greece, 8 drugs were approved for reimbursement, improving patient access to new drugs in the area. Azem placed great emphasis on partnerships between the private, public, and academic sectors, and helped Roche fulfill its role as a trusted partner in building Greece's healthcare system. This has resulted in significant achievements, including bringing patients, the medical community, and companies together to ensure that patients receive healthcare closer to home. Azem graduated from the Hebrew University, where he majored in Medical Sciences. He later obtained an MBA from Tel Aviv University and completed executive education programs at INSEAD (Institut Européen d'Administration des Affaires) Business School in France and London Business School (LBS) in the U.K. The new GM said, “I am delighted to be joining Roche Korea, a country known for its excellent healthcare infrastructure. I look forward to contributing to improving the health of patients in Korea by introducing Roche’s innovative new drugs and personalized treatments, drawing on my various expertise.”
- Company
- 'Leclaza’s 5 counts of clinical results' to be showcased
- by Son, Hyung-Min May 02, 2024 05:53am
- It has been noted whether new anti-cancer candidates from the pharmaceutical and biotech industry in South Korea will be competitive on a global setting. According to industry sources on April 2nd, various Korean pharmaceutical companies, including Yuhan, HLB, and GI Innovation, will attend the 2024 American Society of Clinical Oncology (ASCO 2024) Annual Meeting, which will take place on 31st for five days in Chicago, United States. The AACR is the world’s largest cancer academic conference, at which 400 companies from 120 countries gather annually to present their latest clinical data. Yuhan-Janssen will disclose their major clinical data of Leclaza+Rybrevant Leclaza+Rybrevant combination therapy to be presented at ASCO 2024. Yuhan and its partnering company, Janssen, will present five counts of clinical data results related to Leclaza and Rybrevant combination therapy. Notably, the PALOMA 2,3 trial, which evaluated the effectiveness of the subcutaneous (SC) formulation of Leclaza and Rybrevant, is to be watched. As shifts toward SC formulations gain popularity in anti-cancer immunotherapy, such as Keytruda, Opdivo, and Tecentriq, targeted anti-cancer agents follow suit. Conventional anti-cancer agents are primarily intravenous (IV) therapy, and the administration takes more than one hour. Anti-cancer agents of SC formulation are expected to improve patient convenience since they can significantly reduce the administration duration to within 10 minutes. Phase 3 PALOMA-3 study has evaluated the efficacy and safety of SC formulation Leclaza and Rybrevant therapy compared to IV formulation Leclaza and Rybrevant combination therapy in patients with EGFR positive non-small cell lung cancer (NSCLC) who have failed previous treatments. Furthermore, the Phase 2 PALOMA-2 sutdy evaluated the effectiveness of SC formulation Rybrevant and Leclaza therapy in patients with EGFR-positive NSCLC who have not been treated before. It is to be watched whether the combination therapy of SC formulation can address the concerns regarding infusion-related reactions (IRR) side effects identified in the MARIOSA study. Also, the second analysis results of the Phase 3 MARIPOSA clinical study will be disclosed. These results are from testing the effectiveness of the Rybrevant and Leclaza combination therapy, with interim analysis results for progression-free survival (PFS) and OS previously disclosed in last year’s European Society for Medical Oncology Annual Meeting (ESMO 2023). Results related to high-risk patients with a specific biomarker are anticipated to be presented at this year’s ASCO. This study has evaluated the treatment’s efficacy and safety in comparison to its competitor, Tagrisso by AstraZeneca. Additionally, the clinical results of CHRYSALIS-2 study, evaluating the Leclaza and Rybrevant combination therapy in patients with NSCLC harboring atypical EGFR mutations, will be disclosed. This will be presented by Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital), who directed the MARIPOSA research. The clinical results of the Leclaza and Rybrevant combination therapy in patients with EGFR-mutated NSCLC who have CNS diseases will also be disclosed. HLB to disclose additional results of rivoceranib in treating liver cancer…to showcase anti-cancer immunotherapy GI-102 Korean pharma and biotech companies, including GI Innovation, ABL Bio, NeoImmuneTech, and Qurient, to present their results at ASCO 2024. HLB will present the results of survival duration tracking for liver cancer patients at this conference. Rivoceranib is an oral targeted anti-cancer agent that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), which is involved in tumor angiogenesis. Rivoceranib and camrelizumab combination therapy is currently anticipated to receive approval from the U.S. FDA. In a previously disclosed Phase 3 study of CARES-310, the combination therapy recorded an OS of 22.1 months in patients with liver cancer. The final analysis data of OS will be disclosed at ASCO 2024. GI Innovation will present the Phase 1/2 results of its anti-cancer immunotherapy candidate, GI-102, in metastatic solid cancer. This novel candidate product targets CD80 and interleukin (IL-2), targeting tumors and immune cells. According to interim results from the phase 1/2 clinical trial, GI-102 demonstrated response rates in cancer types unresponsive to conventional anti-cancer immune immunotherapy. Notably, an increase in response rates was observed in melanoma patients who were unresponsive to anti-cancer immunotherapy, with confirmation of proliferation in NK cells and T cells. ABL Bio will present its Phase 1 clinical result of ABL503, a bispecific antibody candidate. ABL503 is a cancer immunotherapy that simultaneously targets PD-1 and 4-1BB. According to the Phase 1 clinical trial result, one instance of complete response (CR) and three instances of partial remission (PR) were confirmed in ovarian cancer patients administered with ABL503. Phase 1 trials of ABL503 are being conducted in 6 agencies in the United States and 3 agencies in South Korea, related to dosage escalation and expansion parts. Once the dosage is determined, the company aims to set the optimal target among solid cancers. NeoImmuneTech will present poster presentations of preclinical data for its NT-I7, an anti-IL-7, in combination with the anti-cancer immunotherapy Keytruda for the treatment of solid cancer. This clinical trial evaluated the efficacy and safety of the combination therapy in 48 patients with pancreatic cancer and 50 patients with microsatellite stable (MSS) colorectal cancers. Qurient will showcase the interim result of the Phase 1 study for the CDK7 inhibitor Q901. Q901 has an underlying mechanism of inhibiting CDK7, a key molecule in regulating the cell cycle. This inhibits DNA damage repairs and increases gene instability, ultimately leading to apoptosis of cancer cells. Qurient is currently conducting a Phase 1/2 trial to evaluate the safety and efficacy of Q901 as a potential anti-cancer treatment in patients with progressive solid cancer. This trial is being conducted in the United States and South Korea.
- Company
- Yuhan earns KRW253.2B through licensing-out deals in 5 yrs
- by Chon, Seung-Hyun May 02, 2024 05:52am
- Yuhan Corp has secured a solid source of revenue with technology licensing fees. Billions of won in profit have been steadily flowing in every quarter through technology licensing deals, the investing company’s development progress, and milestone payments. Yuhan Corp’s cumulative technology fee over the past 5 years amounted to KRW 253.2 billion. According to the company's report on the 2nd, the company's technology fee revenue in Q1 was KRW 2.5 billion. This is down 64.4% from KRW 7.2 billion in the same period of the past year, but it has been 5 consecutive quarters the company has been collecting revenue since the Q1 in the past year. Yuhan’s quarterly technology fee revenue (Unit: KRW million, Source: Yuhan Corp) The CDMO technology fee it had received from its subsidiary Add Pharma played a major part in the company’s Q1 revenue in Q this year. Addpharma specializes in the development of Incrementally Modified Drugs (IMD). In 2022, Addpharma developed a rosuvastatin-ezetimibe combination drug and licensed it to Jeil Pharmaceutical and GC Biopharma. Yuhan acquired Addpharma in 2017 for KRW 3 billion and invested an additional KRW 7 billion in 2022. As of the end of last year, the company held a 67.7% stake in Addpharma. The company also received a portion of the technology fee from Boehringer Ingelheim in the first quarter. In July 2019, the company licensed out YH25724, a candidate drug for non-alcoholic steatohepatitis (metabolic dysfunction-associated steatohepatitis, MASH), to Boehringer Ingelheim for up to USD 870 million. Under the terms of the agreement, a non-refundable upfront payment of USD 40 million was made. In November 2021, YH25724 entered Phase 1 clinical trials, and the company earned an additional USD 10 million in milestone payments. Yuhan Corp has been receiving technology fee revenue since 2018 when it began exporting new drug technology in earnest. In July 2018, the company transferred its YH14618 technology for degenerative disc disease to Spine Biopharma in the US. The company received an upfront payment of USD 650,000 and a guarantee of milestone payments of USD 217.5 million based on development, approval, and sales. In November 2018, Yuhan Corp licensed out its anti-cancer drug Leclaza to Janssen Biotech. The total value of the agreement, including a non-refundable upfront payment of USD 50 million, amounted to USD 1.25 billion. In January 2019, the company entered into an agreement with Gilead Sciences to license and co-develop a drug candidate that acts on two targets for the treatment of nonalcoholic steatohepatitis (NASH). The deal includes an upfront payment of USD 15 million and milestone payments of USD 777 million depending on development, approval, and sales. In August 2020, the company entered into a licensing agreement with the US company Processa Pharmaceuticals to license out YH12852. YH12852 is a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders (FGID). The company received USD 2 million in Processa Pharmaceuticals’ common stock as a non-refundable upfront payment. Since then, the company has been receiving additional payments due to progress in the development stage of its licensed out candidates. In April 2020, the company received a milestone payment of USD 35 million from Janssen. At the time, Janssen paid the additional milestone payment to Yuhan Corp after initiating a clinical trial for amivantamab and Leclaza combination. In November 2020, Janssen paid an additional milestone of USD 65 million to Yuhan Corp after starting subject recruitment for its trial. With the USD 50 million in upfront payment, the company has secured a total of USD 150 million through licensing deal payments with Leclaza. Additional milestone payments are expected once ‘Leclaza receives U.S. approval. Janssen filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) late last year for the combination of Rybrevant and Lexarza for EGFR-positive non-small cell lung cancer. From Q1 2020 to Q2 2021, the company recognized over USD 10 billion as technology fee revenue for 6 consecutive quarters. In Q4 2020, the company recognized a technology fee revenue of KRW 77.7 billion. In the 5 years from 2020 to Q1 this year, the total technology fee revenue recognized by the company amounted to KRW 253.2 billion.
- Policy
- 1488 drugs approved last year…30% diabetes drugs
- by Lee, Hye-Kyung May 02, 2024 05:52am
- A total of 1488 drugs were found to be approved by the Ministry of Food and Drug Safety last year. The MFDS said on the 30th that it published the Drug Approval Report that contains the approval, certification, and report status of drugs, quasi-drugs, and medical devices in 2023. In the case of pharmaceuticals, a total of 1,488 items were approved, including 1,300 finished drugs, 49 APIs, and 139 herbal medicine ingredients. Of the approved finished drugs, 884 (68%) were ETC drugs and 416 were OTC drugs. Also, the number of orphan drug approvals increased continuously, and diabetes drugs accounted for the largest number of approvals among all finished drugs. However, the number of generic drug approvals has steadily decreased after the ‘1+3 system’ was implemented. In terms of the total number of finished drug approvals, diabetes drugs accounted for the largest number of approvals, totaling at 462. This is more than 30% of all finished drugs. This was followed by antipyretic, analgesic, and anti-inflammatory drugs (120 items), other vitamins (87 items), and blood pressure-lowering drugs (77 items). In terms of synthetic drugs approved last year by type, 29 were new drugs, 22 orphan drugs, 390 data submission drugs (including 15 incrementally modified drugs), and 2 APIs. The number of new drug approvals increased by about 50% compared to 2022 to 29 (5 manufactured and 24 imported), and the top efficacy categories by the number of approved items were nervous system drugs (7), diabetes drugs, and antineoplastic agents (6 each), circulatory system drugs and blood and body fluid agents, respiratory system drugs and allergy drugs (3 each). In the case of orphan drugs, a total of 37 products that contain 26 ingredients were approved last year, an increase of 4 ingredients and 7 products from the previous year. This is a threefold increase from 2019 (9 ingredients), which is likely due to increased industry investment and active government support for orphan drug development. Of the 375 new data submission drugs, 50.4% (189) were submitted for new salts or isomers, followed by 24.5% (92) for new compositions, and 13.3% (50) for new dosage forms (with the same route of administration). Looking at the types of incrementally modified drugs developed and approved in recent years, in 2016-2017, the development of combination drugs (drugs containing two or more active ingredients in a single product) with new active ingredient compositions was popular, and in 2018, 6 sustained-release drugs with improved dosing and dosage by reducing the number of required doses were approved. Last year, a total of 15 products were approved, including 14 combination drugs with new active ingredient compositions and 1 product that improved utility by developing a product with different efficacy and effectiveness. Last year, a total of 802 generic drugs were approved and reported. Other drugs accounted for the largest share of generic drugs. Also, 15 of the synthetic drugs among data submission drugs were recognized as incrementally modified new drugs. Since July 2021, the number of applications for generic approvals decreased sharply until 2022 due to the implementation of the '1+3' system, which limits the use of the same clinical trial data to 3 times. The number of applications in 2023 is on par with those in 2022. A total of 929 quasi-drugs were approved and reported. This was mainly due to the eased mandatory requirement and decreased wearing of masks, as well as the active development of quasi-drugs related to daily life, such as sanitary napkins, band-aids, and toothpaste due to the growing interest in health. A total of 7065 medical devices were approved, certified, and reported, with an increase in ▲high-tech medical devices such as artificial intelligence-based medical devices and surgical rehabilitation robots. Also, ▲ medical device software items are on the increase, and ▲digital treatment devices and heavy-ion particle therapy devices were introduced as new means of treatment.
- Policy
- 32 med schools in KOR confirm their admission quota
- by Lee, Jeong-Hwan May 02, 2024 05:52am
- Prime Minister Han Duck-soo. The 32 medical schools that were assigned increased medical admission quota from the government confirmed their final medical admission quota for the 2025 academic year. After withdrawing the initial announcement of increasing the medical school admission quota to 2,000 students, the government allowed universities to adjust their intake autonomously. As a result, the expansion of the 32 medical schools is anticipated to be around 1,550 students. The Korean Council for University Education (KCUE) plans to review changes to next year's college admissions process, including medical school admission quotas submitted by each university. It will notify the universities of the decisions by the end of this month. On May 1st, Prime Minister Han Duck-soo chaired the "Central Disaster and Safety Countermeasures Headquarters Meeting regarding the doctors' collective" at the Government Complex Seoul. During the meeting, he stated, "The 32 medical schools across the country that have increased their quotas have determined the admission quotas for the 2025 academic year and submitted them to the KCUE." The nine regional national universities have decided to reduce 50% of the previously allocated expansion quotas and recruit accordingly. Most private universities have decided to fully utilize the expansion quotas or reduce them slightly by 10 to 20 students. If Soonchunhyang University, Dankook University, Konyang University, and Cha University, which have not disclosed the exact expansion size, decide to recruit 100% of the allocated expansion quotas, the total number of medical school admissions for next year is estimated to be around 1550. According to Han, the KCUE is scheduled to disclose the results of each university’s medical school admission quota on May 2nd. "The President and the main opposition party leader had a long conversation on Monday regarding national affairs. They discussed the medical school expansion and healthcare reform in particular," Han said. "This reflects the support and desire for healthcare reform." "The government will continue communicating effectively with the National Assembly throughout the healthcare reform process," Han added. "We strongly encourage the medical community to engage in dialogue with the government actively." "If the medical community brings forward a scientific and rational single proposal, the discussion on the expansion scale beyond the 2026 academic year is possible," Han said. "However, it is regrettable that another group of hospital professors plans to go on strike this Friday," he added. “While patients feel anxious, some professors say they are to leave their side,” Han said. “I urge medical school professors to continue to stay by the patient's side as they have done so far, and residents and medical students should also return now,” Han emphasized. The Prime Minister also suggested that they plan to discuss allowing doctors to hold additional positions at 119 emergency centers and metropolitan emergency medical situation rooms to respond to emergency patients. Han explained, "We are working to immediately improve regulations in the medical field to allow general practitioners to treat patients in emergency rooms of other medical institutions and permit trauma center specialists to provide emergency room and inpatient care outside their centers." "Today at the Central Disaster and Safety Countermeasures Headquarters meeting, We will discuss ways to facilitate cooperation between universities and hospitals to ensure swift approval for doctors who wish to work in 119 emergency centers and metropolitan emergency medical situation rooms, thereby enhancing emergency patient response capabilities," Han added.
