Development and Approval Dynamics of Generic Drugs in China
First Approval and Market Launch of Newly Registered Classification VarietiesAccording to the PharmCube data research, the current statistical period (2025.01.25-02.07)Newly Added15A newly registered classification with the first approval receipt number, involving11Varieties, including21 tablet, 3 injections, 1 liniment, 1 fine granule, 2 capsules, 1 gel patch, and 1 transdermal patchCompared with the last statistical period, this time there are 5 new registered classification varieties that have passed the review for the first time.。
First to Pass the New Registration ClassificationSituation (Part)
Ixazomib Citrate Capsules
Citrate Ixazomib is an orally administered, highly selective proteasome inhibitor originally developed by Millennium Pharmaceuticals (acquired by Takeda in 2008). Clinically, it is used in combination with lenalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy. On November 20, 2015, citrate ixazomib capsules were approved by the FDA for marketing in the United States. A year later, on November 21, 2016, they successfully passed EMA approval and entered the European market. On April 12, 2018, the original citrate ixazomib capsules were approved for import by the NMPA, under the trade name Ninlaro.According to the Generics Library research from PharmaDJ, there are currently two companies in China that possess the production approval for Ixazomib Citrate Capsules. These include the original developer, Takeda Pharmaceuticals, and Qilu Pharmaceutical Co., Ltd., which has now obtained the first generic approval.PharmCube Data - Information from China's Registration Database shows that Qilu Pharmaceutical exclusively filed a Category 4 generic application for Ixazomib Citrate Capsules in October 2023, and this week it was deemed to have passed the evaluation, successfully securing the "first generic + exclusive" for this product. In addition, companies such as Sinopharm Huadong and Tasly Diyi Pharmaceuticals are conducting BE trials for this product and have not yet submitted production applications.Statistics from the Pharma Data-China Sales Database show that the sales of Ixazomib Citrate Capsules have continued to rise since entering the Chinese market, with very impressive figures. In 2021, sales reached a peak of 674 million yuan. Although there was a subsequent decline, the total sales for 2023 remained above 532 million yuan. Notably, Ixazomib Citrate Capsules were included in the Class B National Medical Insurance Catalog in 2024, improving patient accessibility. In the first two quarters of 2024, sales exceeded 300 million yuan, and it is certain that the annual sales will surpass 600 million yuan.Status of the First Approved Market Launch for Consistency Evaluation VarietiesAccording to the PharmaBlock data research, the statistical cycle for this period (2025.01.258-02.07)Add 1The first batch of consistency evaluation approvals involves one variety, including one injectable.。Compared with the last statistical period, this time there is one additional variety that has passed the first consistency evaluation.First to Pass the Consistency EvaluationSituation
Approval Status of Newly Registered Classification VarietiesAccording to the PharmCube data research, during this statistical period (January 25, 2025 - February 7, 2025), 43 new acceptance numbers for new registration categories were added, involving 30 varieties.Including 78 tablets, 8 injections, 1 liniment, 1 eye drop, 1 dry suspension, 4 capsules, 3 oral solutions, 1 gel patch, 1 cream, 1 transdermal patch, 1 inhalation solution, and 1 fine granule. Compared to the last statistical cycle, this round saw a reduction of 23 newly registered and approved varieties.
Approval Status of Newly Registered Classification Varieties (Partial)
Approval and Marketing Status of Consistency Evaluation VarietiesAccording to the PharmaBlock data research, during this statistical period (January 25, 2025 - February 7, 2025), five new acceptance numbers for consistency evaluation were added, involving four varieties, including three injections and one tablet.Compared with the last statistical period, this time increased by 1.A consistency evaluation approved variety.
Status of Consistency Evaluation Varieties Passing the Assessment
Status of Approval for Generic Drug Clinical TrialsStatus of Rejection/Active Withdrawal of Generic Drug Varieties R&D and Application Trends of Generic Drugs in China
Status of New Registration Category Varieties Submitted for Market LaunchAccording to the PharmaBlock data research, during this statistical period (January 25, 2025 - February 7, 2025), 185 new acceptance numbers under the new registration classification were added, involving 132 varieties, including45 tablets, 34 injections, 1 liniment, 7 eye drops, 3 dry suspensions, 2 suspensions, 6 capsules, 3 granules, 15 oral solutions, 3 gel patches, 1 solution, 3 powders, 3 patches, 1 inhalation powder, 1 inhalation aerosol, 2 inhalation solutions, 1 inhalation preparation, 1 lotion. Compared with the last statistical period, this time there are 17 more registered classification application varieties.
Acceptance Status of New Registration Classification Varieties (Partial)
Status of Consistency Evaluation Product Submissions for Market ApprovalAccording to the PharmCube data research, during this statistical period (January 25, 2025 - February 7, 2025), there were 13 newly accepted application numbers for consistency evaluation, involving 9 varieties, including 2 tablets, 6 injections, and 1 capsule.Compared with the last statistical period, this time there are 4 fewer varieties of consistency evaluation applications.
Acceptance Status of Consistency Evaluation Applications
Status of Generic Drug Supplemental ApplicationsSummary of Patent Statements for Generic Drug Applications Generic Drugs in ChinaR&D Focus Areas
Policy and Regulatory Updates in China's Generic Drug Development SectorAnnouncement of the National Medical Products Administration on Revising the Instruction Manual for Gemifloxacin Mesylate Tablets (No. 13, 2025)According to the evaluation results of adverse drug reactions, and in order to further ensure public medication safety, the National Medical Products Administration has decided to uniformly revise the instruction manual for Gemifloxacin Mesylate Tablets. The relevant matters are hereby announced as follows:1. The marketing authorization holders of all the above-mentioned drugs should revise the package inserts according to the requirements in the annex, in compliance with the Regulations for Drug Registration and other relevant provisions, and submit them for filing to the Center for Drug Evaluation or provincial drug regulatory authorities before May 4, 2025.
If the revision involves drug labels, it should be revised accordingly; other contents of the instructions and labels must be consistent with the originally approved content. For drugs produced after the filing date, the original drug instruction cannot be used. The marketing authorization holder of the drug must replace the instructions and labels of the drugs already on the market or inform patients of the updated information in other forms within 9 months after the filing.
II. The marketing authorization holder of pharmaceuticals shall conduct in-depth research on the mechanisms of newly added adverse reactions, take effective measures to promote the publicity and training regarding drug use and safety issues, and guide physicians and pharmacists in the rational use of drugs.
3. Clinical physicians and pharmacists should carefully read the revised content of the aforementioned drug instructions, and when selecting medications, they should conduct a thorough benefit/risk analysis based on the newly revised instructions.
4. Patients should carefully read the drug instructions before taking the medication, and strictly follow the doctor's advice when using prescription drugs.
V. Provincial drug regulatory authorities should ensure that the marketing authorization holders of the aforementioned drugs within their administrative regions revise the package inserts, replace labels and package inserts, and notify updates as required. Illegal activities must be severely punished according to law. This is to announce.
Hot News in China's Generic Drug R&D FieldTianyu Co., Ltd.: Announcement on the Approval of the Company's Active Pharmaceutical Ingredients by CDE
On January 27, Zhejiang Tianyu Pharmaceutical Co., Ltd. announced that the active pharmaceutical ingredient (API) of Avatrombopag Maleate produced by the company has recently passed the review of the Center for Drug Evaluation under the National Medical Products Administration. The relevant information is hereby announced as follows:I. Basic Information of the DrugDrug Name: Avatrombopag MaleateDosage Form: Active Pharmaceutical IngredientRegistration Category: Chemical Drug Class 4API Registration Number: Y20230000333Co-review and co-approval result of the formulation: A2. Other Relevant Information about the DrugAvatrombopag Maleate can be used for adult patients with chronic liver disease-related thrombocytopenia who are scheduled for diagnostic procedures or surgery. Patients with chronic liver disease should not use this product to restore normal platelet counts.The company submitted a drug registration application for the active pharmaceutical ingredient (API) of Avatrombopag Maleate to the CDE in June 2023, which was accepted. The API of Avatrombopag Maleate has now passed the CDE review. Before it can be marketed and sold in China, it must receive a "meets requirements" announcement following a GMP compliance inspection by the Zhejiang Provincial Drug Administration.III. Impact on the Company and Risk WarningsAccording to the disclosure on the CDE website, as of the announcement date, there are 14 manufacturers in China (excluding the company) that have passed the CDE technical review for this active pharmaceutical ingredient. The company’s Avatrombopag Maleate active pharmaceutical ingredient has not yet completed the GMP compliance inspection and is currently preparing to apply to the Zhejiang Provincial Drug Administration for a GMP compliance inspection of this variety.Little D Has Something to Say
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