Amjin, the Pharmaceutical Express, waived its rights to leprosy and tuberculosis products

December 25, 2020 / Medical Information At a Glance: The list price in the seven provinces' consumables negotiations is finally announced; the first MAH commissioned production inspection points will be implemented on New Year's Day; RegenxBio's $200 million sale of some of Zolgensma's patent rights... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief The price target price in the seven provinces of supplies negotiations was finally announced, according to the Guangdong Provincial Health Insurance Bureau, Guangdong Province held a coronary artery balloon expansion catheter-type medical supplies seven provinces (autonomous regions) alliance group with volume procurement information open conference, Jiangxi, Henan, Guangxi, Ningxia, Qinghai, Shaanxi and other provinces (autonomous regions) participated in the alliance group procurement.
varieties mainly include expansion balloons and drug balloons, the final expansion balloons decreased by an average of 92.23 percent, drug balloons decreased by an average of 44.45 percent.
(Guangdong Provincial Health Insurance Bureau) the first MAH commissioned production inspection points will be implemented on New Year's Day, Hunan Provincial Drug Administration official website issued on the issuance of "Hunan Province drug listing license holders (commissioned production situation) inspection points (trial)" notice, effective from January 1, 2021, valid for 2 years, this is 20 After the implementation of the Drug Administration Law on December 1, 19, the first domestic inspection guidelines for MAH (commissioned production situation), the national level has not specifically formulated the relevant acceptance standards, this acceptance standard for the domestic entrusted to others to produce preparations MAH to apply for drug production license on-site inspection provides a reference at the regulatory and technical levels.
(Official Website of Hunan Provincial Drug Administration) Part 2 Vice President Li Xinlei resigned on the 24th, Fosun Pharma announced that the board of directors received a written resignation letter from Vice President Li Xinlei.
, Mr. Li Xinlei, applied to the Board of Directors of the Company to resign as Vice President due to his work arrangements.
(Fosun Pharma Announcement) Amgen's waiver of rights to leprosy and tuberculosis products comes after Amgen and Australia's non-profit Global Health Drug Development (MDGH) Ltd. announced that they have signed a licensing agreement for AMG 634, a type phosphate dylase 4 (PDE4) inhibitor that is being studied for the treatment of tuberculosis and leprosy-related erythema, the latter of which is a complication of skin and systemic inflammation caused by leprosy.
the terms of the agreement, MDGH will be responsible for the further development and commercialization of AMG 634.
. -- Regenx Bio's $200 million sale of part of Zolgensma's patent rights was announced to Healthcare Royalty (HCR) for $200 million.
(Sina Pharmaceutical News) Strong Body Pharmaceuticals 100% equity listing transfer floor price adjustment day, Sapp Ace issued a notice that the wholly-owned subsidiary Strong Body Pharmaceuticals 100% equity listing transfer floor price adjusted to 70% of the assessed value, that is, 137 million yuan, and has started the next round of listing transfer procedures.
(Sap Ace Announcement) ONL completed a $46.9 million Round B financing, Michigan-based ONL Therapeutics announced the completion of a $46.9 million Round B round of financing, Bios Partners led the round of financing, Johnson and Johnson Innovation, Capay Capital, PSQ Capital and Michi Venture Capital Network Fund III and other institutions are also involved in this round of financing.
(Creative Exchange) Part 3 Pharmaceutical Information Lilly CDK4/6 inhibitor Abemaciclib domestic listing in recent days, Lilly CDK4/6 inhibitor Abemaciclib tablet (i.e., Abesili tablet) listing application changed to "in-approval" in the status of the NMPA, which means that the domestic second CDK4/6 inhibitor is about to be approved.
(CPhI Pharmaceutical Online) Merca East CTLA-4 monoantigen/PD-1 monoantigen combination therapy clinical application was accepted on the 25th, CDE website publicity shows that Mercadon in China submitted a class 1 new drug MK-1308A injection clinical trial application, and was accepted.
according to publicly available information, MK-1308A is a joint treatment of MK-1308 and pembrolizumab, of which MK-1308 is an anti-CTLA-4 antibody introduced from Kangfang Bio, pembrolizumab is Merca East's star anti-cancer drug PD-1 inhibitor PD-1 inhibitor Ttruta.
(CDE official website) Hengrui Pharmaceutical CDK 4/6 inhibitor Phase 3 clinical research reached the main endpoint 24, Hengrui Pharmaceutical announced that it in the study CDK 4/6 inhibitor SHR6390 tablets in a patient with advanced breast cancer phase 3 clinical end.
results showed that SHR6390 combined fluoravis groups significantly extended patients' progression-free survival compared to placebo combined fluoravis groups.
(Pharmaceutical Mission) Jia and Bio-introduced CDK 4/6 inhibitor clinical applications were accepted by the CDE website the latest publicity, Jia and Bio from G1 Therapeutics introduced a class 1 new drug lerociclib tablets in China declared clinical trials, and was accepted.
, according to publicly available information, lerociclib is a potential "best-in-class" oral CDK 4/6 inhibitor and is currently conducting Phase 1/2 clinical trials worldwide.
(CDE official website) Hutchison Whampoa "Sovantini capsule" will soon be approved for listing recently, Hutchison Whampoa Pharmaceuticals Class 1 new drug Sovantini capsules in China's listing application into the "in the approval" stage, is expected to be approved by NMPA in the near future.
is intended to be marketed as the treatment of advanced non-pancreatic neuroendocrine tumors.
(Pharmaceutical Rubik's Cube) 13 varieties through the consistency evaluation of two drugs for the first time 25, the State Drug Administration official website shows 13 generic drugs through the consistent evaluation, of which, Zhejiang Hudison and Shandong Runze injection of cephalosporin sodium, Beijing Ted and Nanjing Jianyou's benzene Shun Aquku ammonium injections are the first simultaneous evaluation varieties.
(National Drug Administration) FDA approved the first oral new drug for bladder overactive disorder Urovant Sciences recently announced that the U.S. FDA has approved a daily 75mg gemtesa (vibegron, Vibergron) for the treatment of patients with acute urinary incontinence, uremia, urinary frequency of bladder overactive disorder.
, Gemtesa marks the first FDA-approved oral brand of OAB since 2012, and the first product approval for Urovant Sciences.
(Bio Valley) rare childhood epilepsy drug Findepla was approved by the European Union recently, Zogenix announced that the European Commission has approved Fenfluramine (fenfluramine, fenfluoramine) oral solution, as an additional therapy for other anti-epileptic drugs, for patients aged ≥2 years old to treat seizures related to Dravet syndrome.
(biogu) green leaf pharmaceutical class 1 new drug LY03012 completed phase I clinical research recently, green leaf pharmaceutical announced its class 1 new drug LY03012I phase I study, the results show that healthy subjects take 80 to 400mg a single time, 7 days after taking 80 to 320mg a day after the overall safety, tolerance is good.
LY03012 is known to treat chronic pain such as nerve pain, fibromyalgia and osteoarthritis around diabetes.
(Pharmaceutical Rubik's Cube) Renitin suspended sales in the European Union recently, the European Commission issued a legally binding final decision on the suspension of renitin sales, which applies to all EU member states - the latest treatment given by the EU for some time for Renitetin drugs.
(Seber Blue)