R&D and Approval Updates of Generic Drugs in China
First Approval and Market Launch of Newly Registered Classification VarietiesAccording to the PharmaBlock data research, during this statistical period (June 28, 2025 - July 4, 2025), there were 16 newly registered first-category acceptance numbers that passed evaluation, involving 13 varieties, including 4 tablets, 4 injections, 4 eye drops, and 1 granule. Compared with the previous statistical period, this time there was an increase of 13 newly registered first-category varieties that passed evaluation.
First Evaluation Status of Newly Registered Classification Varieties'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Lifitegrast Ophthalmic Solution (Xiidra®) was originally developed by SARcode Bioscience (acquired by Shire Dev LLC in 2013, which was subsequently acquired by Takeda in 2019; in the same year, Novartis acquired Xiidra®) as the first-generation lymphocyte function-associated antigen-1 (LFA-1) antagonist. This small-molecule integrin inhibitor targets the core mechanism of dry eye disease—T-cell-mediated inflammatory response. By binding to lymphocyte function-associated antigen-1 (LFA-1), it blocks the interaction between LFA-1 and intercellular adhesion molecule-1 (ICAM-1), cutting off the inflammatory chain at its source, thereby simultaneously improving both symptoms of dry eye (such as dryness and foreign body sensation) and signs (such as corneal fluorescein staining).According to Pharma Intelligence data, Lifitegrast Ophthalmic Solution was approved by the FDA in July 2016 for formal launch in the United States, becoming the world's first and only prescription LFA-1 antagonist approved for treating both signs and symptoms of dry eye disease (DED). Global sales in 2022 exceeded $480 million.In December 2023, Lifitegrast Eye Drops were included in the National Health Commission's "Third Batch of Encouraged Generic Drug List," and the patent for the compound Lifitegrast is set to expire in China by the end of 2024. Against the backdrop of policy incentives and patent expiration, multiple companies in China are accelerating their efforts to develop Lifitegrast Eye Drops.According to the Generics Database research from PharmaDJ, only Kanghong Pharmaceutical in China holds the production approval for Lifitegrast Eye Drops. Sapaias, Hangzhou Baicheng Pharmaceuticals, Chenxin Buddha Pharmaceuticals, and Lunan Better Pharmaceuticals are all conducting BE trials.Due to space limitations, only the progress of the first five companies' applications is shown. For more information, please check PharmaBlock data.-Generic Drug LibraryAccording to the PharmaDATA-China Registration Database, as of now, besides Kanghong Pharmaceutical, Qilu Pharmaceutical has also submitted a generic application for Leflunomide Eye Drops (Category 3), which is currently in the review and approval process.Acceptance Status of Leflunomide Eye Drops New Registration Classification Application
The core mechanism of Lifitegrast lies in its globally exclusive small-molecule integrin inhibitor technology — by blockingLFA-1/ICAM-1Interaction, Full-chain InhibitionTCell-mediated inflammatory pathways. Clinical data show that patients using5%Concentration of Leflunomide Eye Drops2Symptoms can be significantly alleviated in weeks, while the traditional drug cyclosporine eye drops need to be combined with artificial tears for treatment.12Weeks or more.
However, the difficulty of imitating this technology is extremely high. Although the patent for the original drug2024It will expire in China at the end of the year, but due to the complex synthesis process and strict quality control, Kanghong Pharmaceutical is the only domestic company to successfully break through the technical barriers. This week, Kanghong Pharmaceutical received the drug approval, becoming the "first company" for lifitegrast ophthalmic solution.+"Exclusive" Enterprise.
The blue light from electronic screens is shining on the eyes of modern people, also igniting a huge market. With the popularity of electronic devices, the acceleration of population aging, and the spread of poor eye habits, the number of dry eye patients in China has broken3Hundred Million Mark. However, the treatment drugs for dry eye syndrome in China are mainly imported products, which are expensive. After Kanghong Pharmaceutical's first generic drug enters the market, it is expected to quickly penetrate the market through centralized procurement and medical insurance negotiations, providing Chinese dry eye patients with more efficient and affordable treatment options.
Status of the First Approved Market Launch for Consistency Evaluation VarietiesAccording to the PharmaData research, there were no newly accepted applications for the first batch of consistency evaluation in this statistical cycle (June 28, 2025 - July 4, 2025). The number of products passing the first batch of consistency evaluation remained the same as in the previous statistical cycle.Approval Status of Newly Registered Classification Products for Market LaunchAccording to the data research from PharmaDJ, during this statistical period (June 28, 2025 - July 4, 2025), there were 206 newly registered approvals added under the new classification, involving 124 varieties. These include 35 tablets, 38 injections, 1 liniment, 1 drops, 9 eye drops, 1 dry suspension, 1 suspension, 12 capsules, 5 granules, 8 oral solutions, 1 gel, 2 gel patches, 2 creams, 1 ointment, 3 powders, 1 inhalation powder, and 3 inhalation solutions. Compared with the previous statistical period, this time saw an increase of 122 newly registered varieties under the new classification.
Approval Status of Newly Registered Classification Varieties (Partial)
Approval Status of Consistency Evaluation Varieties for MarketingAccording to the PharmaData research, during this statistical period (June 28, 2025 - July 4, 2025), there were 18 newly accepted applications for consistency evaluation, involving 10 varieties, including 1 tablet, 8 injections, and 1 capsule. Compared with the previous statistical period, one more variety has been approved for consistency evaluation in this period.
Status of Consistency Evaluation Varieties
Status of Clinical Approvals for Generic DrugsStatus of Rejection/Active Withdrawal of Generic Drug VarietiesR&D and Application Trends of Generic Drugs in China
Status of New Registration Classification Product Applications for Market LaunchAccording to the PharmCube data research, in this statistical cycle (2025.06.28-07.04), 90 new registration classifications were added.A new application number covers 59 varieties, including 22 tablets, 21 injections, 2 eye drops, 2 suspensions, 2 capsules, 2 granules, 4 oral solutions, 1 film, 1 cream, and 2 inhalation solutions. Compared with the previous statistical cycle, this round sees a decrease of 5 newly registered classified application varieties.
Status of Acceptance for New Registration Categories (Partial)
Status of Consistency Evaluation Product Submissions for Market ApprovalAccording to the PharmaData research, during this statistical period (June 28, 2025 - July 4, 2025), there were six newly accepted application numbers for consistency evaluation, involving three varieties, including two tablets and one injection. Compared with the previous statistical period, the number of consistency evaluation application varieties decreased by two in this period.
Acceptance Status of Consistency Evaluation Applications (Partial)
Status of Generic Drug Supplemental ApplicationsSummary of Patent Statements for Generic Drug ApplicationsGeneric Drugs in ChinaR&D Field Hotspots Focus
Policy and Regulatory Updates in China's Generic Drug Development FieldAnnouncement of the National Medical Products Administration on the Cancellation of Registration Certificates for 56 Drugs Including Pediatric Electrolyte Supplementation Injection (No. 62, 2025)
According to the relevant provisions of the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China" and the "Measures for Drug Registration," the National Medical Products Administration has decided to cancel the registration certificates of 56 drugs, including Pediatric Electrolyte Supplementation Injection. This is hereby announced.Hot News in China's Generic Drug R&D Field
Sinopharm Modern: Announcement on the Approval Notice for the Market Application of Chemical Raw Materials by a Wholly-Owned Subsidiary
On June 28, Shanghai Modern Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, China National Pharmaceutical Group Industrial Co., Ltd., had received the "Approval Notice for Chemical Raw Material Drug Marketing Application" issued by the National Medical Products Administration, approving the marketing application for the raw material drug Penehyclidine Hydrochloride. The relevant details are announced as follows:I. Basic Information of Chemical Raw Materials for PharmaceuticalsName of Chemical API: Penehyclidine HydrochlorideRegistration No.: Y20230001255Notice Number: 2025YS00511Chemical API Registration Standard No.: YBY65962025Packaging Specifications: 0.1kg/bag, 0.2kg/bag, 0.5kg/bag, 1kg/bagManufacturer: Langfang Branch of China National Pharmaceutical Group Industrial Co., Ltd.Enterprise Address: Chuangye Road, Langfang Economic and Technological Development ZoneApplication Matter: Marketing Application for Chemical Active Pharmaceutical Ingredients Produced in ChinaApproval Conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after examination, this product meets the relevant requirements for drug registration and is approved for registration.2. Drug Research and Development and Market SituationPenehyclidine Hydrochloride is a selective anticholinergic drug, widely used for pre-anesthetic medication to inhibit salivary and airway gland secretion, as well as for emergency treatment of organophosphate poisoning (pesticides) and maintenance of atropinization in the late stage of poisoning or after cholinesterase (ChE) aging.According to the CDE website, the current registration status of penehyclidine hydrochloride API marked as "A" includes domestic companies such as Jiangsu Enhua Pharmaceutical Co., Ltd., Chongqing Huasen Pharmaceutical Co., Ltd., and Grand Life Sciences (Wuhan) Co., Ltd. The company is temporarily unable to obtain market sales data for the above products through public channels.To date, China National Pharmaceutical Industry has invested approximately RMB 480.50 million in cumulative R&D expenses for this project (unaudited).3. Impact on the Company and Risk AlertsThe approval of the marketing application for Sinopharm Industry's Penehyclidine Hydrochloride API will help the company to promote the integration of the industrial chain of related products, enhance the market competitiveness of the company’s products, and bring positive impact to the company’s future development.
For consultation and cooperation, please contact the author.
Little D Has Something to Say
For the convenience of readers to read and save, we have organized the original weekly report into a PDF version. If you need to obtain the full text, you can click the blue text at the top."Pharmadupe" Official AccountReply "0709 Weekly Report" in the background to get the full text.
