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- 2026-04-11 09:37:23
- Company
- JW signs new anti-cancer drug R&D contract with KURE AI
- by Nho, Byung Chul Nov 02, 2022 05:35am
- Park Chan-hee, chief technology officer of JW Group (left) and David Ward, CEO of KURE AI Theraputics, are taking photosJW Group announced on the 1st that it has signed a joint research contract with U.S. bio venture company KURE AI Therapeutics to develop innovative anti-cancer drugs based on artificial intelligence (AI). Under this contract, JW Pharma and JW CreaGene will launch research and development of three new anticancer drugs using KURE AI's artificial intelligence and machine learning-based genetic analysis and biomarker search platform. JW Pharmaceutical will discover a new low-molecular anticancer drug task with KURE AI targeting patients with immune anticancer drug-resistant solid cancer. It will also establish a strategy to increase the clinical success rate of candidates for new anticancer drugs developed by JW Pharmaceutical. JW CreaGene, a research firm of JW, works with KURE AI to derive candidates for new CAR-NK cell therapy for solid cancer treatment. It plans to expand the pipeline of new immune cell treatments along with dendritic cell treatments and CAR-macrophage treatments that are currently being researched and developed. "We are very excited to promote an innovative joint research project with JW Group, which has competitiveness in developing new drugs tailored to patients," said David Wald, CEO of KURE AI. "We will strengthen cooperation to achieve the result of developing next-generation new drugs for precise cancer treatment." Park Chan-hee, CTO of JW Group, said, "We will expand the new drug pipeline through joint research with KURE AI, which has a global-level anti-cancer drug brokerage clinical research platform." CTO Park Chan-hee said, "We plan to further expand joint research with overseas companies that have specialized innovation R&D platforms." JW Pharma and JW CreaGene are actively promoting open innovation) to expand the new drug pipeline by combining their own R&D platform to discover new drug candidate materials and platforms of promising bio companies at home and abroad. Currently, in addition to KURE AI in the U.S., it is collaborating with seven domestic biotech companies, including Voronoi, Deargen, Iliasbio, Organoidsciences, Oncocross, SyntekaBio, Oncoinsight Since July, it has been looking for joint research partners with ARCH Venture Partners, the largest bio and healthcare venture capital in the United States, to expand its open innovation target overseas.
- Company
- RET-targeted Retevmo reattempts reimb listing in Korea
- by Eo, Yun-Ho Nov 01, 2022 06:02am
- The RET-targeted anticancer therapy ‘Retevmo’ will reattempt reimbursement listing in Korea. According to industry sources, Lilly Korea’s Retevmo (selpercatinib) will be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) tomorrow on November 2nd. Retevmo received marketing authorization in March this year and was deliberated by CDDC for reimbursement in May. After deliberation, the CDDC decided not to set reimbursement standards for the drug. Whether a different conclusion will be made this time remains to be seen. The CDDC’s review process was raised as an issue at the recent NA Audit. Rep. Gi-Yoon Kang of the People Power Party pointed out the lack of rationale for the CDDC’s not setting reimbursement standards within HIRA’s reimbursement process. According to Rep. Kang, the CDDC made the decision not to set reimbursement standards for anticancer drugs that had applied for reimbursement with Phase II clinical trials due to their absence of Phase III trial data, but this undermines the purpose of drugs that received approval under the condition of conducting Phase III trials in the future. However, HIRA said what it requested was additional data, not Phase III trial data, that could explain the clinical efficacy of the drugs, as it lacks data comparing its efficacy with existing treatments (indirect comparative data with existing treatments, real-world data, reimbursement evaluation results abroad, etc.) In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene 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. The drug demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. In the trial, the overall response rate (ORR) of patients with RET fusion-positive NSCLC without prior platinum-based treatment experience that was treated with Retevmo was 85%. Although the median duration of response (DoR) was not yet reached, 79% of the patients showed continued response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
- Policy
- LG Chemical completed Vimovo's domestic copyright
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- LG Chem has acquired the domestic copyright of the complex "Vimovo," which combines NSAIDs-based anti-inflammatory analgesics (Naproxen) and PPI-based gastroesophageal reflux disease treatment ingredient Esomeprazole. Vimovo is a product released in Korea by AstraZeneca Korea in 2012 and has been jointly selling it with LG Chem. As Vimovo's global copyright was recently transferred to a German pharmaceutical company, LG Chem seems to have bought domestic copyrights. According to industries on the 31st, Vimovo 500/20mg, which has been transferred and transferred by LG Chem, will be registered from the 1st of this month. LG Chem acquired the product from AstraZeneca Korea. Until now, Vimovo had been copyrighted by AstraZeneca Korea in Korea. LG Chem has been a joint sales partner since the beginning of marketing. LG Chem's acquisition of Vimovo this time is interpreted as a chain phenomenon that occurred when Vimovo's global copyright moved. In 2018, AstraZeneca sold its global copyright to Vimovo (excluding the United States and Japan) to German pharmaceutical company Grünenthal. As joint sales cooperation became difficult, LG Chem is believed to have acquired Vimovo's domestic copyright. Vimovo has attracted attention since its launch in 2012 as a product that minimizes concerns over gastrointestinal side effects by combining PPI drugs with NSAIDs-based anti-inflammatory analgesics. In particular, synergy was expected in that it combined AstraZeneca's original Esomeprazole ingredient product Nexium. Hanmi Pharmaceutical's Naxozol came out the following year and competed against each other. In 2014, Chong Kun Dang launched "Naxen S," a generic drug, and four companies, including SK Chemicals, began selling improved new drugs, and the NSAIDs-PPI complex market entered a multilateral competition system. According to the amount of out-of-house prescriptions based on UBIST last year, Vimovo rose 20% year-on-year to 20 billion won and Naxozol rose to 22.8 billion won, slightly higher in Naxozol. In the case of the generic Naxen S, it was only 3.4 billion won. Although Vimovo's patent is now expired, it is still dominant in the market. Attention is focusing on whether LG Chem, which took over the copyright, will be able to rise to the top of the market with momentum.
- Company
- Bukwang applies for approval of Lurasidone
- by Nov 01, 2022 06:02am
- Bukwang Pharmaceutical announced on the 31st that it has applied for an item permit for Lurasidone, a new drug for treating schizophrenia and bipolar depression, from the Ministry of Food and Drug Safety. Lurasidone is a treatment for depression with schizophrenia and bipolar disorder developed by Sumitomo Pharma, Japan. Bukwang Pharmaceutical has exclusive development rights and copyrights in Korea. Bukwang Pharmaceutical recently announced that Lurasidone proved non-differential compared to the existing schizophrenia treatment "Quetiapine" in the top-line results of phase 3 clinical trials for schizophrenia patients. Lurasidone has lower metabolic adverse reactions such as weight gain, prolactin gain, dyslipidemia, and hyperglycemia than conventional atypical antipsychotics, improving patients' social life and quality of life. Lurasidone can also be used as a treatment for bipolar disorder depression, where drug selection is very limited. Lurasidone is an antagonist that blocks dopamine D2, serotonin 5-HT2A, and 5-HT7 receptors, which also partially act on serotonin 5-HT1A receptors and show little affinity for histamine H1 and muscarinic M1 receptors. According to Bukwang Pharmaceutical, Lurasidone has been approved as a treatment for schizophrenia and bipolar depression in more than 45 countries, including the United States and the European Union. The largest sales in the North American market reached about 2.6 trillion won. Bukwang Pharmaceutical said, "Lurasidone is expected to improve the quality of life of patients with proven treatment effects and safety for depression with schizophrenia and bipolar disorder."
- Policy
- It doesn't mean that we're considering a reduction
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- Minister Cho Kyu-hongThe Ministry of Health and Welfare explained in writing about Minister Cho Kyu-hong's answer to the government audit site on the 6th about Korea's generic insurance drug price, which was set at an expensive price. The remarks at the time came as Choi Jae-hyung, a lawmaker of the People's Power, responded to a question that "the price of generic drugs in Korea is too high than overseas, so the price of drugs should be lowered." Minister Cho agreed and said, "Each country's generics prices are closely related to the country's health and medical policies, and we have improved the drug price system so that the drug price policy can be implemented in stages to reduce health insurance finances and ease users' economic burden." The Ministry of Health and Welfare said in a written response to a recent question by Rep. Jeon Hye-sook of the Democratic Party of Korea that the remarks at the time "did not answer that they would consider a lump-sum reduction in the weak." She explained, "The intention is to manage the price of generic drugs at an appropriate level in consideration of the financial burden of health insurance and the economic burden of patients and to continuously improve the drug price system." The MOHW added, "The improvement of the insurance drug price system will be carried out after collecting sufficient opinions by comprehensively considering securing the sustainability of health insurance, improving patient access to treatments for severe and rare diseases, efficient spending management, and the impact on the pharmaceutical industry." After the remarks by the head of the National Assembly were made public, the pharmaceutical industry's strong opposition is believed to have put it on the condition of its impact on the pharmaceutical industry and sufficient collection of opinions.
- Policy
- Gov’t to fully investigate its COVID-19 research support
- by Lee, Tak-Sun Nov 01, 2022 06:02am
- The Ministry of Health and Welfare announced that it will conduct a full investigation on all of the projects it had supported for the clinical trial research of COVID-19 treatments and vaccines by the first quarter of next year. Since 2020, a total of 10 companies were selected for the government's COVID-19 treatment and vaccine clinical support project. Although these companies received state support for clinical research, only two succeeded in commercialization. Due to this lack of results, the question of whether the state’s support was excessive has been rising. With the People Power Party determining the project as a project badly managed example of the previous administration, what the results of the MOHW investigation will be is receiving keen attention. At the NA Audit that had been held on the 20th, the MOHW agreed to Rep. Gi-Yoon Kang’s criticism that "the development of COVID-19 vaccines and treatments should continue, but sanctions are needed for companies that were found to have caused market disruption or embezzled business expenses.,” and promised it will investigate related projects by the 1st quarter of next year. The MOHW said, “We plan to continue supporting the development of COVID-19 vaccines and treatments through the K-Bio Vaccine Fund worth a total of KRW 500 billion in 2023, but agree with the representative that measures are needed for companies that have done wrong through measures such as market disruptions or embezzlement." The ministry added, "We will conduct an investigation by the 1st quarter of next year to see if there were any problems in the process of research and evaluations conducted on companies that participated in the COVID-19 treatment and vaccine clinical support project, and report the results to Rep. Kang’s office.” 10 companies were selected for the COVID-19 treatment and vaccine clinical support project that had been carried out 3 times since 2020. The selected companies were Celltrion, GC Pharma, Daewoong Pharmaceutical, Genexine, SK Bioscience, GeneOne Life Science, Cellid, Eu Biologics, HK Inno.N, and Quratis. This was a megaproject whose budget reached KRW 232.8 billion from 2020 to 2021. However, among the 10 companies, only Celltrion and SK Bioscience succeeded in commercialization. Celltrion succeeded in developing an antibody treatment for COVID-19 and SK Bioscience succeeded in developing a vaccine for COVID-19. The other companies have discontinued development or are having difficulty commercializing their products. The members of the People Power Party had focused on this issue at the NA Audit. In particular, they raised their voice on whether GC Pharma received preferential treatment in receiving state support for its discontinued plasma therapy candidate. Kang had previously pointed out that “Even though the clinical trial for GC Pharma’s COVID-19 plasma therapy had been discontinued abroad after the US National Institutes of Health determinized the drug lacked efficacy, the company still applied for conditional marketing authorization for the candidate to the MFDS in Korea. In the process, GC Pharma’s stock price rose from KRW 90,000 to KRW 300,000.” Rep. Jong-Hean Baek of the People Power Party also said, “GC Pharma stopped developing treatments even after receiving support for KRW 5.8 billion, which accounts for 60% of the total of KRW 9.7 billion spend spent on researching its COVID-19 plasma therapy. Wasn’t this just the company’s attempt to defraud the government or raise their stock price?" However, GC Pharma is known to have returned KRW 1.97 billion of the supported fund to the Korea Health Industry Development Institute (KHIDI). The recent police investigation into Il-Yang Pharmaceutical for raising its stock price by inflating its COVID-19 treatment research results is adding to the suspicions. The MOHW also stressed, "If problems such as market disruption or embezzlement of business expenses of companies that received government support are revealed in the course of investigations conducted by the police or other investigative agencies in the future, we will conduct a further investigation."
- Policy
- It takes 218 days to register after applying for a new drug
- by Kim, Jung-Ju Oct 31, 2022 06:07am
- Among the new drugs introduced in Korea, drugs that started the payroll process from insurance application to registration last year took an average of 218 days. Among them, the treatment for rare diseases took 238 days and the anticancer drug took 227 days. Considering that the legal processing period is 7 months (210 days), the government emphasized that it is relatively quickly registered. The Ministry of Health and Welfare submitted the results of the tally to the question of the duration of new drug benefits demanded by Kang Ki-yoon, a member of the National Assembly's Health and Welfare Committee, during the last comprehensive parliamentary audit. According to the Ministry of Health and Welfare, the government has been operating Approval-Patent Linkage Systems, RSA, PE system, and drug price negotiation training system to strengthen access to new drug patients. Looking at the aggregated data, the actual average registration period from application for drug decisions to benefit registration over the past five years was about 6.2 months. This is the average value after calculating the time it takes to complete the notification from the application for the HIRA drug benefit adequacy to the passage of the Health Insurance Policy Review Committee for each drug. The Ministry of Health and Welfare evaluated, "Considering the seven months (210 days) of the legal processing period for drug registration, it is being registered relatively quickly." It took 227 days for anticancer drugs and 238 days for rare diseases. Comparing the recent five-year trend, there were delays by year or ups and downs in the required period. It is analyzed that this is because it varies depending on the appearance of ultra-high-priced drugs, the difficulties of benefits review (ICER value and acceptance of companies), and the number and type of drugs applied for registration. Even if the number of days is prolonged, it means that it is difficult to simply compare the period required by year, but it can be seen that new drugs are generally being paid at a level similar to the legal processing period. The MOHW said, "The new government is also revising related regulations to shorten the evaluation period by selecting 'quick registration of anticancer drugs, severe disease treatments, and applying risk-sharing drugs' as state tasks" and the government said it will collect opinions from various stakeholders on the "improvement of reference standards for foreign drug prices (A7) adjusters" that are being discussed so far. In the case of the A7 adjustment price reference standard, the government is using the adjustment price converted from foreign drug prices in the evaluation of new drug benefit adequacy to determine insurance drug prices. However, due to the long-standing and insufficient evidence of the foreign drug price reference standard, long-term improvement reviews are underway to enhance transparency and clarity of the adjusted price and supplement its validity. Earlier, the government held expert advisory meetings based on related research services from 2019 to 2020, and formed a public-private working-level consultative body, including related associations, to discuss improvement measures by holding six working group meetings. The Ministry of Health and Welfare said, "In the process of improving reference standards, such as revising related guidelines, we will fully collect opinions from various stakeholders such as patients, experts, and pharmaceutical companies."
- InterView
- “BMS makes the next leap with its solid pipeline”
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- 이혜영 대표 Mergers have become one of the main survival strategies for global multinational pharmaceutical companies. In addition to buying new substances, companies are also making synergy, absorbing companies that own pipelines with high potential. BMS is one representative example of such successful mergers. When the power of its portfolio declining with the patent expiration of blockbuster drugs such as 'Baraclude Tab.', the company decided to acquired Celgene, the company that owns ‘Revlimid,’ the drug that recorded the highest sales among prescription drugs at the time. In addition to CAR-T therapy, Celgene owned various candidate substances in various areas including blood cancer. In addition, the company also signed an agreement to copromote ‘Opdivo’ with the Japanese pharmaceutical company ‘Opdivo,’ to build competitivity in the oncology sector. Its Korean subsidiary is also working to quickly conclude the merger process and make the next leap with the organizational restructuring. In this whirlwind of change, the company has newly welcomed a new leader. Hye-Young Lee, who has serves as the founding Country Manager of BMS, is dreaming of a new heyday at BMS with her appointment in July. Dailypharm met with the new Country Manager. -It hasn’t been long since you took office. Some might think it is too early to conduct an interview. Is there a reason why you decided to do the interview at this time? I wanted to publicize BMS as it is now. Since we have not conducted many external activities, including media activities, I thought that our business scale and the potential for growth has not been well known. Although there are still a lot of things that I would need to understand in terms of business, I thought it would be good to start by relaying the changed status of our company and its future direction. -You have been a Country Manager before, but this is a new company. What was your first impression about BMS?? As I had only known the company as a member in the same industry before, I was surprised in many aspects after joining the company. BMS's business scale, global presence, and pipelines were much stronger than I expected, and the company owns various industry-leading promising pipelines. -Could you introduce some of those strong pipelines? BMS’s main pipeline cover the 5 fields including Cardiology, Hematology, Oncology, Immunology, and Neuroscience. More than 50 new drug candidates for more than 40 diseases are being developed in these five areas. Based on those that received current domestic or FDA approval, we have Revlimid and Sprycel in Hematology, as well as Onurec, Inrevic, and Reblozyl that were additionally approved this year. In addition, two CAR-T treatments approved by the FDA are receiving much anticipation these days. Our cardiovascular pipeline has been further strengthened by acquiring a company called Myokardia, and there is a treatment for hypertrophic obstructive cardiomyopathy that was approved by the US FDA this year. This first-in-class treatment with a new mechanism of action has been receiving high expectations. We cannot disclose details as it has not been approved in Korea yet, but we are working hard to introduce it quickly to domestic patients. In terms of Immunology, there are treatments for plaque psoriasis and ulcerative colitis with a new mechanism of action that has been recently approved by the FDA. In addition, the treatments it acquired from Turning Point Therapeutics are also from a new class but is yet to be approved in Korea. -BMS two new CAR-T therapies, Breyanzi and Abecma. The two are also in the process of approval. When looking at existing cases, simply introducing CART-T therapies is not enough, and many other preparations are needed for their prescription. How are you preparing for this part? As CAR-T is an innovative therapy that is needed by many patients in Korea, we are continuously reviewing the preparations necessary for the patients in need of treatment in Korea. However, as mentioned, use of CAR-T therapies require various considerations and preparations, therefore, its introduction requires more time. One encouraging fact is that a clinical trial is planned for one of the CAR-T therapies in Korea. It is expected that the experience we are accumulating with clinical trials will be helpful when introducing CAR-T treatments in the future -If you look at BMs, the company is actively engaging in mergers, joint development, and promotion activities. Is there a possibility of expanding such partnerships with Korean companies? Open innovation is the DNA of BMS, to such an extent that 60% of the BMS pipeline has been secured through open innovation, and 40% of current sales were accrued from drugs developed through open innovation. We also plan to actively carry out open innovation in Korea, and a lot of clinical trials are already underway. There are 50 clinical trials in progress in about 20 pipelines in progress in Korea. Unlike the past, where many clinical trials for new drug development were traditionally conducted in the US and Europe, Korea is now in the spotlight in conducting early-phase clinical trials, and is also considered one of the most important countries in terms of expansion. One aspect I found impressive after joining the company was in the number of early clinical trials being conducted in Korea. 6 Phase I clinical trials are underway, and the company is also seeking ways to collaborate with one of the country's major hospitals for basic research related to oncology and hematology.
- Company
- MET-targeted anticancer drug Tabrecta reattempts reimb
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- Once again, the MET-targeted anticancer drug Tabrecta is attempting to receive insurance reimbursement in Korea. According to industry sources, Novartis Korea has recently started the reimbursement process for Tabrecta (capmatinib in Korea. As the agenda was unable to pass deliberation by the Health Insurance Review and Assessment Service’s Cancer Disease Drug Committee deliberations in August, whether the company will succeed in its second attempt for reimbursement remains to be seen. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non small-cell lung cancer (NSCLC). No treatment option had been available in the type until now. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in May 2020. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta respective drugs with other therapies. In particular, the combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum- based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso.
- Policy
- Koselugo & Retevmo's benefit registration can be shortened
- by Lee, Tak-Sun Oct 31, 2022 06:06am
- The registration of drug benefits such as Koselugo and Retevmo, which are currently under evaluation, is expected to be shortened by 30 days. This is because the NHIS and the HIRA have decided to shorten the benefit registration period for drugs used in life-threatening diseases. Koselugo and Retevmo are drugs licensed through the Ministry of Food and Drug Safety's rapid screening system and are considered life-threatening or significant treatments. This fact was revealed in the HIRA's written answer to the question asked by Rep. Seo Young-seok of the Democratic Party of Korea during the parliamentary audit on the 20th. Seo asked about "a specific plan to strengthen the information sharing and cooperation system among related ministries related to enhancing the consistency between the rapid review system of the Ministry of Food and Drug Safety and the review of benefit registration." The HIRA said, "We want to shorten the insurance registration period of the drug by shortening the period required for negotiations on the NHIS' drug price at the same time as we evaluate the drug used for life-threatening diseases," adding, "We will try to provide related data to the NHIS so that patients can receive health insurance benefits as soon as possible." Currently, opinions are being collected on ways to shorten the period of benefit registration for severe and rare drugs without alternative drugs. The HIRA and the NHIS are set to take effect in November. The main content is that the HIRA provides preliminary data on the drug to the NHIS before the Drug Benefit Evaluation Committee, which will shorten the negotiation by 30 days by conducting preliminary negotiations. There are three life-threatening or serious disease treatments currently being reviewed by the HIRA: Koselugo, a type 1 treatment for childhood neurofibroma over the age of 3, Retevmo, a treatment for metastatic non-small cell lung cancer, and Rybrevent, a treatment for patients with local progressive or metastatic non-small cell lung cancer. However, Rybrevant has voluntarily withdrawn its application for a decision due to reasons such as the supplementation of data. If Koselugo and Retevmo are scheduled to be deliberated by the committee, they will engage in preliminary negotiations with the NHIS. Accordingly, if the appropriateness of the benefit is recognized, the main negotiation with the NHIS will end within 30 days. If it took 75 days from the holding of the existing committee to the drug price negotiation, the registration will be decided 45 days from now on.
