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- 2026-05-13 22:01:02
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- Immuno-oncology drugs set out to conquer early stage cancer
- by Nov 03, 2022 05:54am
- Pic of Opdivo, Keytruda, Tecentriq, Imfinzi The use of immuno-oncology drugs has advanced to the frontline of early-stage cancers. This is because data has demonstrated that the use of immuno-oncology drugs in the early stages increases the possibility of surgery and reduces the possibility of metastasis and recurrence. Following their use in the field of non-small cell lung cancer (NSCLC), immuno-oncology drugs are evaluated to be paving the way for early treatment in difficult-to-treat cancer types such as melanoma, bladder cancer, esophageal cancer, and breast cancer. BMS and Ono Pharmaceutical’s anti-PD-1 immunotherapy Opdivo (nivolumab) has recently received approval for use in early-stage NSCLC. The Ministry of Food and Drug Safety approved the drug in combination with platinum-based chemotherapy for ‘resectable (tumor size larger than 4cm or benign lymph node) on the 26th of last month. With the approval, Opdivo became the first immuno-oncology drug allowed for use as adjuvant therapy in early-stage, resectable lung cancer patients. Even with the addition of targeted anticancer drugs, Opdivo is the only drug that can be used as neoadjuvant therapy. Previously, Tagrisso, an EGFR-targeted treatment, was approved as an adjuvant treatment in NSCLC. The Phase III CheckMate-816 trial(ONO-4538-55), which became the basis for the approval, enrolled patients with stage IB-IIIA NSCLC to compare Opdivo+chemotherapy with chemotherapy monotherapy. Its primary efficacy endpoint was event-free survival (EFS) and pathologic complete response (pCR) rate as assessed by the blinded independent central review (BICR). The secondary efficacy endpoint was overall survival (OS) and major pathologic response (MPR), and time to death or distant metastases. Results showed that in patients receiving Opdivo+chemotherapy, the median EFS was 31.6 months, decreasing the risk of relapse or death by 37% compared to 20.8 months of patients treated with chemotherapy alone. The pCR was 24% in the Opdivo group, and 2.2% in the control group. While the data are still immature, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy. In the interim analysis, Opdivo+chemotherapy reduced the risk of death by 43%. Further analysis will be conducted in the future as the data is yet to reach statistical significance. Compared to how 83% of the patients that received treatment with Opdivo+chemotherapy survived after 2 years, the survival rate of those that only received chemotherapy was 71%. Also, 83% of the patients who received Opdivo+chemotherapy received operations, compared with the 75% in chemotherapy-treated patients. Rates of Grade 3-4 treatment-related adverse events were similar even with the addition of Opdivo to chemotherapy versus chemotherapy alone (34% vs. 37%). Immuno-oncology competition extends to early-stage lung cancer In addition to Opdivo, other immuno-oncology drugs are also challenging the market. Companies are conducting trials on Keytruda, Imfinzi, and Tecentriq to verify their efficacy as adjuvant or neoadjuvant therapy. In October last year, the FDA approved Roche’s Tecentriq (atezolizumab) as adjuvant treatment in patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells. In Europe, the indication was expanded for patients whose tumors have a PD-L1 expression ≥ 50% based on the interim analysis that showed a high effect in that patient group. Interim analysis results showed that adjuvant Tecentriq resulted in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher. Based on such findings, Roche is also planning to expand Tecentriq’s indication in Korea within the year. MSD’s Keytruda (pembrolizumab) is aiming to expand its indication as adjuvant therapy in patients with early-stage NSCLC (Stage IB-IIIA) regardless of PD-L1 expression. Interim analysis results of the Phase III KEYNOTE-091 study that was presented earlier this year showed that Keytruda significantly improved disease-free survival (DFS), which was one of the primary efficacy endpoints, and reduced risk of recurrence or death by 24% compared with placebo. The median progression-free survival [PFS] of the Keytruda-treated group was 53.6 months and 42.0 months for the placebo group. AstraZeneca’s Imfinzi (durvalumab) also presented positive results as a neoadjuvant therapy before surgery based on the interim results from the Phase III AEGEAN trial that was presented in July. The trial evaluated Imfinzi in combination with neoadjuvant chemotherapy as perioperative treatment for patients with resectable Stage IIA-IIIB NSCLC, and results showed that the combination therapy significantly improved pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone. However, other primary and secondary efficacy endpoints of the trial, including event-free survival (EFS), disease-free survival, overall survival, etc. To esophageal cancer, bladder cancer, and melanoma... use as early treatment expanded to various cancer types The entry of immuno-oncology drugs to early-stage cancer is not limited to NSCLC. Opdivo demonstrated its efficacy as adjuvant therapy in melanoma, bladder cancer, and esophageal cancer as well. Its indications are: ▲as adjuvant therapy in patients with lymph node involvement or metastatic Stage IIIB/C or IIII melanoma who have undergone complete resection; ▲as adjuvant therapy in patients with non-muscle-invasive bladder cancer (NMIBC) at high risk of recurrence after radical surgical resection ▲as neoadjuvant therapy for completely resected esophageal or gastroesophageal junction cancer in patients with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Moreover, study results that demonstrate Opdivo’s effect as adjuvant therapy in patients with Stage IIB-IIC melanoma, an earlier stage than the existing indications, were also presented recently. Interim analysis results of CheckMate-76K that was presented last month showed that Opdivo as adjuvant therapy reduced the risk of recurrence or death by 58% versus placebo in patients with completely resected Stage IIB or IIC melanoma. Opdivo’s 12-month recurrence-free survival (RFS) was 89% versus 79% for the placebo group. Keytruda also obtained an indication as adjuvant therapy in patients with Stage IIB or IIC melanoma who have undergone complete resection and renal cell carcinoma (RCC) with a high risk of recurrence following nephrectomy. In triple-negative breast cancer (TNBC), Keytruda was approved as both adjuvant and neoadjuvant therapy. In other words, in TNBC, Keytruda can be used in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
- Policy
- Akynzeo is licensed domestically
- by Kim, Jung-Ju Nov 03, 2022 05:54am
- The Ministry of Food and Drug Safety has landed in Korea with new drug imported by HK inno.N. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) approved Akynzeo, an imported new drug of HKinno.N, on the 31st, which prevents nausea and vomiting caused by the administration of chemotherapy drugs. This is a drug for preventing acute and delayed nausea and vomiting caused by initial nausea and vomiting prevention or repeated treatment among adults receiving moderate or higher vomiting-induced chemotherapy. The mechanism of action of Palonosetron and Netupitant, the active ingredients, inhibits the neural pathways involved in inducing nausea and vomiting, and both ingredients have a long half-life in plasma, which is effective as an antiseptic, according to the Ministry of Food and Drug Safety. Akynzeo is expected to contribute to improving the quality of life of patients by helping to prevent nausea and vomiting in patients who are difficult to take the existing oral formulation Akynzeo capsule with intravenous injections. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand the treatment opportunities of patients in the future so that treatments that have been sufficiently confirmed in safety and effectiveness are quickly supplied based on regulatory science expertise."
- Policy
- NHI big data was used to evaluate safety of JAK inhibitors
- by Lee, Tak-Sun Nov 02, 2022 05:36am
- Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters held a press conference with its press corp on the 1st to explain the HQ’s main projects and plans. Big data from the National Health Insurance was found to have been used to evaluate the safety of JAK inhibitors, based on which its use has been restricted in high-risk patients in Korea. This is the first time that NHI big data had been used for safety evaluation of pharmaceuticals in Korea. The National Health Insurance Service’s Big Data Strategy Headquarters held a press conference with the press corp on the 1st at its Wonju headquarters to deliver this news. Soon-Ae Shin, Deputy Minister of the NHIS Big Data Headquarters, said, “We established a consultative body with the Ministry of Food and Drug Safety to conduct joint research on information related to the real use of pharmaceuticals and conducted a safety evaluation on JAK inhibitors used for rheumatoid arthritis, etc with the consultative body for the first time this year.” The NHIS performed a comparative analysis on the incidence of major cardiovascular diseases and mortality rate of TNF blockers and JAK inhibitors using NHI big data. In June, based on the results derived using big data and expert deliberations, the MFDS revised the approved label for JAK inhibitors so that patients 65 years of age or older, patients at high cardiovascular risk, and patients at risk of malignancies could only use JAK inhibitors if they see inadequate treatment effect from existing treatment options. Since last September, reimbursement standards have also been revised accordingly and applied to prescriptions. Jong-Hun Park, Deputy Minister of NHIS’s Big Data Strategy HQ, said, “We conducted big data research for two to three months per MFDS's request. Although the decision was made after expert deliberations by the Central Pharmaceutical Affairs Council, our study has also contributed to the policy decision-making process.” The NHIS is also known to be conducting safety evaluations on other pharmaceuticals using big data. The MFDS evaluated JAK inhibitors after acquiring safety information from overseas sources including the US FDA in September last year. The US FDA had restricted the use of JAK inhibitors to specific patients that do not respond or show intolerance to TNF blockers, as it can increase the risk of severe heart-related events including heart attacks. Europe has also first limited the use of tofacitinib, a JAK class inhibitor, to high-risk groups who have suitable treatment alternatives, and is reviewing the need for applying additional measures on other JAK inhibitors. Until now, the MFDS had used data on adverse reactions that had been collected separately for drug safety evaluations. The added reflection of NHI big data in drug safety evaluations is expected to allow customized measures to be made in Korea that reflects the domestic environment. Deputy Minister Shin said, “ We expect our research to verify drug safety and efficacy based on NHI big data to expand further around the consultative body.” NHIS also plans to support the research and development of real-world evidence (RWE) on pharmaceuticals ㅕusing big data. In other words, it aims to organically link NHI big data for use from the drug development stage to post-marketing research. In the preclinical development stage, big data is expected to be used to analyze the characteristic of the target disease and patient group, analyze existing treatment (drug prescription, etc.) patterns, explore combinations for drug development, drug repositioning, etc. In the clinical trial stage, it is expected to be used for clinical trial design support, estimation of a number of clinical trial subjects, support of the control group to ultimatley reduce the clinical trial period and improve the efficiency of clinical trials. Also, the NHIS added that big data can be used in various areas in the post-marketing stage as well, including for comparative evaluation between competitors, feasibility study of research topics, and post-marketing monitoring of drugs subject to re-examinations.
- Policy
- "Synthetic Biology" that Moderna used
- by Kang, Shin-Kook Nov 02, 2022 05:36am
- Deputy Prime Minister Choo Kyung-hoThe Act on Research Promotion and Support for Synthetic Biology' proposed legislation in the first half of next year. Support measures will be prepared for Synthetic Biology, which is evaluated to double the efficiency of research and development of innovative new drugs and materials. Deputy Prime Minister for Economic Affairs and Minister of Strategy and Finance Choo Kyung-ho presided over an emergency economic ministers' meeting at the Seoul Government Complex on the 1st and discussed plans to secure new growth engines such as bio. Considering the characteristics of Synthetic Biology, which is accompanied by innovation and risk, the government will propose a new law in the first half of next year to promote technology development and manage transparency at the national level. The name of the bill is the 'Act on the Promotion and Support of Synthetic Biology Research'. The government has decided to prepare a "National Synthetic Biology Initiative" this month to create a bio-innovation ecosystem based on Synthetic Biology and to respond strategically to global technology hegemony competition. This will include a comprehensive policy direction from a long-term perspective that encompasses R&D, infrastructure construction, industrial use, and ecosystem creation to secure core technologies. The government will establish 'Biofoundry', a key infrastructure to accelerate innovation in Synthetic Biology technology and strengthen domestic bio-manufacturing competitiveness. Biofoundry will be invested 300 billion won over five years from 2024 to 2028, and will be organized by the Ministry of Science and Technology. In addition, the government decided to revitalize the "Korea Synthetic Biology Development Council" to create a private-centered Synthetic Biology development ecosystem and gather domestic industry, academia, and research capabilities. Currently, 58 organizations, including 20 companies, 26 universities, and 12 contributing associations, are participating in the council. The government will hold a joint Korea-U.S. Synthetic Biology conference in December to lay the foundation for research cooperation with the U.S., a leading technology player in Synthetic Biology, and promote cooperation among major research institutes. Synthetic Biology means creating a life system by synthesizing genes. Synthetic Biology technology is evaluated as a key technology that can change the flow and landscape of all fields of the red, green, and white bio industries, and has also been designated as one of the top 10 core technologies in the U.S. Innovation Competition Act. In fact, Moderna shortened the development period by using Synthetic Biology in the process of developing the COVID-19 mRNA vaccine.
- Company
- Hanmi achieves record quarterly performance in 7 years
- by Chon, Seung-Hyun Nov 02, 2022 05:36am
- Hanmi Pharmaceutical recorded the highest performance in 7 years since 2015. Its sales and operating profit were the largest since Q4 2015 when it signed a series of mega technology export deals, thanks to the success of its new combination drug and Beijing Hanmi. On the 1st, Hanmi Pharmaceutical officially announced that its operating profit had increased 26.9% compared to the same period of the previous year to reach KRW 46.8 billion in Q3. Its sales revenue had also increased 12.9% to reach KRW 342.1 billion, and net profit by 11.5% to reach KRW 31.3 billion. The company’s cumulative operating profit had risen 44.2% compared to the same period of the previous year to reach KRW 119.2 billion, and its sales rose 15.0% in the same period to reach KRW 980.4 billion. The sales and operating profit made by Hanmi Pharmaceuticals in Q3 this year are the largest made since Q4 2015. In Q4 2015, Hanmi Pharmaceuticals signed a series of mega licensing-out deals and recorded sales of KRW 589.9 billion and an operating profit of KRW 171.5 billion. Quarterly Sales of Hanmi (left) operating profit (right) (Unit: KRW 1 million, data: FSS) Hanmi Pharmaceuticals said, “This is the first time since our establishment that our quarterly sales exceed KRW340 billion excluding technology fees from overseas.” The new combination drug developed by Hanmi Pharmaceuticals outperformed itself in the domestic market. According to the market research institution UBIST, outpatient prescription sales of its hyperlipidemia combination drug Rosuzet reached KRW 36.4 billion in Q3, which is a 13.5% increase from Q3 of the previous year. Its cumulative sales reached KRW 103 billion in Q3 this year. Launched at the end of 2015, Rosuzet is a combination drug that consists of two ingredients - rosuvastatin and ezetimibe – and is used to treat hyperlipidemia. Rosuzet is the first homegrown new drug to exceed outpatient prescription sales of KRW 100 billion in only 3 quarters. As Rosuzet’s sales exceeded KRW 100 billion in 2020 and the previous year, with the record, Rosuzet’s sales are set to exceed KRW 100 billion for three consecutive years. The company’s new fixed-dose drug combination, the Amosartan family, is also showing steady growth. Hanmi Pharmaceuticals has been selling the amlodipine and losartan combination Amosartan as well as Amosartan Plus, Amosartan Q, and Amosartan XQ. Amosartan Plus is a combination of three drugs, amlodipine, losartan, and chlorthalidone. Amosartan Q is a combination of Amosartan and the hyperlipidemia treatment rosuvastatin. Amosartan XQ is a combination of Amosartan, rosuvastatin, and ezetimibe that was released last year. Prescriptions of Amosartan in Q3 increased 1.1% from the same period of the previous year to record KRW 21.1 billion. Prescription of Amosartan Plus decreased 1.1% YoY to record KRW 7.1 billion, and Amosartan Q, Amosartan made KRW 2.9 billion and KRW 1.8 billion, respectively. Also, Hanmi Pharmaceutical’s Chinese subsidiary, Beijing Hanmi, showed improved performance. Beijing Hanmi recorded sales of KRW 93 billion in Q3 this year, making a 23.4% YoY increase. Its operating profit has also grown 25.5% to reach KRW 24.2 billion. Beijing Hanmi has been growing with the annual rise in demand for its key products including Mamiai (pediatric digestive supplement with lactic acid bacteria), Etanjing (cough medicine), and Leeddong (laxative), etc. An official from Hanmi Pharmaceutical said, “We have living up to our management slogan of ‘sustainable innovative management,' which was demonstrated through our excellent performance this year. We will do our best to present a management model for the Korean pharma-bio industry while endeavoring to support Korea's growth into a pharmaceutical powerhouse as a native Korean pharmaceutical company.”
- Product
- A fierce battle between MDs & RPhs on Rx of ingredient names
- by Kang, Shin-Kook Nov 02, 2022 05:36am
- A fight between pharmaceutical organizations has begun over the prescription of ingredient names. Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, made an excuse to actively agree to the prescription of the ingredient name, and complaints that have accumulated have been erupting. First, doctors are insisting that patients choose in-house and outpatient preparations. It is also a new opinion of doctors to use a dispensing vending machine. Some suggested that if a vending machine is introduced, doctors will guide the medication directly without receiving medication. In addition, when prescribed with the ingredient name, pharmacists choose the medicine, and the drug equivalence for the generic selected by pharmacists is a major argument against the ingredient name prescription. However, pharmacists say that it is difficult to understand why doctors are prescribing generic drugs, saying that equivalence is a problem. In the end, generic selection may be made by rebates. Pharmacists believe that the recent issue of stock-saving is largely due to the prescription of brand names, not ingredient names and that if cold medicines were prescribed under ingredient names, the inconvenience of patients who could not get drugs would have been reduced. Prescribing ingredient names should be led by the Ministry of Health and Welfare. The Ministry of Food and Drug Safety is not a competent ministry. Nevertheless, why are doctors strongly opposed to the KFDA's statement that they "agree actively" rather than pushing for it? The background of the remarks made by the head of the Ministry of Food and Drug Safety was the inquiry of Seo Young-seok (Democratic Party of Korea), a pharmacist. In the end, doctors seem to have some kind of agreement between a pharmacist-turned-lawmaker and the head of the MFDS and have started to issue prescriptions for ingredient names. However, from the perspective of the pharmaceutical society, prescribing ingredient names is a long-term task, not an urgent task. The agenda only includes activating generic dispensing and the principle of using the international general name (INN) of the patent expiration drug product name. The pharmaceutical society cannot easily talk about prescribing ingredient names. The Pharmaceutical Association said, "One factory is producing the same product under dozens of product names and distributing it on the market." The association said, "Because the situation is like this, prescribing ingredient names and activating generic dispensing are essential policies." The Pharmaceutical Affairs Association said, "Just because there is no ingredient name prescription in the policy proposal, it does not mean that we have given up on promoting the policy. It means prioritizing policies that can be done immediately, such as simplifying post-notification of generic dispensing and introducing INN, he said. What is the situation with the Medical Association? Apart from statements from the Pediatric and Adolescent Association, the Seoul Metropolitan Council, the doctors union, and the opening association, the Medical Association has already sent an official letter of protest to the Ministry of Food and Drug Safety. The Medical Association criticized, "Prescription of ingredient names is a serious matter that undermines prescription rights, patient's right to care and health," adding, "The statement of agreeing to the ingredient name is a serious statement that encourages confusion in the national medical system beyond personal opinion." The Medical Association said, "The prescription of ingredients should be decided only by considering national health as a top priority," adding, "If the government sees this only from an economic perspective in terms of reducing the burden of national drug costs and health insurance drug costs, it is best to abolish the division of medicine and select division of labor." The response to the prescription of the ingredient name of the Medical Association was only a selective division of labor.
- 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."
