Qilu Pharmaceutical Achieves Dual Milestone: 200 Million-Yuan GnRH Antagonist Approved and Novel Class 1 Drug QLS4131 Enters Clinical Development for Multiple Myeloma

Jul 24, 2024 20:30 CST Updated 20:30

Qilu Pharmaceutical

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On July 24, according to the latest announcement on the NMPA official website,Qilu PharmaceuticalReport on the Production of Generic Category 4Ganirelix Acetate InjectionApproved and deemed to have passed the evaluation. Recently, the CDE official website showed that the company's Class 1 new drugQLS4131 for InjectionReceived clinical trial implied permission for the treatment of multiple myeloma.

Screenshot source: NMPA official website

200 Million Injection Battle, Qilu Pharmaceutical Approved

GanirelixThe original manufacturer isOrganon(Spin-off from Merck)。Ganirelix AcetateThis is a GnRH antagonist, Ganirelix Acetate.(GnRH)Antagonist, specifically designed for use in assisted reproductive technology(ART)Controlled Ovarian Stimulation(COS)Used in women for the prevention of premature luteinizing hormone surge(LH)Peak. Driven by both the original research and Zhengda Tianqing, sales in China's hospital market grew rapidly. 2023Ganirelix Acetate InjectionSales in hospitals across China approached 200 million yuan, with a year-on-year increase of 9.50%.

Screenshot source:PharmCube National Hospital Sales Database

Excluding the original research(Organon), there is also in the Chinese market.Zhengda Tianqing, Nanjing Kangzhou Pharmaceutical, Shenzhen Hanyu PharmaceuticalThree pharmaceutical companiesGanirelix Acetate InjectionHas been approved for marketing, Qilu Pharmaceutical is the 4th domestically produced product in China. Currently,Ganirelix Acetate InjectionIn addition, seven pharmaceutical companies, including Chenxin Pharmaceutical, Hunan Kelun Pharmaceutical, and Yangtze River Pharmaceutical, have submitted generic applications, all of which are currently under review and approval.

Screenshot source:PharmCube China Drug Evaluation Database

From 2024 to date, Qilu Pharmaceutical has had 28 varieties pass the evaluation, among whichEltrombopag Ethanolamine Tablets, Bendamustine Hydrochloride Injection Concentrate, Tafamidis Meglumine Soft Capsules, Metformin Empagliflozin Tablets (Ⅵ), Entrectinib CapsulesFive varieties are the first domestic generics in China.

Screenshot source:PharmCube Approved Drugs Summary Database

Another Class 1 New Drug Hits the Market, Targeting the Billion-Dollar Anti-Tumor Drug Sector

QLS4131 for InjectionIt received clinical trial implied permission for the first time in July this year and is proposed for development to treat multiple myeloma. According to the PharmaOcean database, in 2023 in the Chinese hospital market for antineoplastic and immunomodulatory drugs(Chemical or biological drugs)Sales exceed 140 billion yuan, with a year-on-year increase of 7.33%.

Screenshot source:PharmCube National Hospital Sales Database

Since 2024, Qilu Pharmaceutical's innovative R&D pipeline has continued to advance, and this year the company has already...QLS4131 for Injection, QL1706 Injection, QLS31905 for Injection, QLF31907 for InjectionSeven Class 1 new drug applications have been submitted and approved for clinical trials.

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