R&D and Approval Updates for Generic Drugs in China
First Approval and Market Launch of Newly Registered Classification VarietiesAccording to the PharmCube data research, there were no newly registered first-class acceptance numbers in this statistical cycle (2024.07.06-07.12). Compared with the previous statistical cycle, thisReduce 10 newly registered classified first-to-market varieties.
Status of the First Approved Market Launch for Consistency Evaluation VarietiesAccording to the PharmaBlock data research, there were no new first-to-pass consistency evaluation cases in this statistical cycle (July 6, 2024 - July 12, 2024). Compared with the previous statistical cycle, there was a reduction of one first-to-pass consistency evaluation product in this cycle.
Approval Status of Newly Registered Classification Varieties for MarketingAccording to the PharmCube data research, the statistical cycle this time ((2024.07.06-07.12) No new acceptance numbers for newly registered categories were added during this period. Compared with the previous statistical cycle, there was a decrease of 70 newly registered category varieties.
Approval Status of Consistency Evaluation Varieties for MarketingAccording to the PharmaBlock data research, during this statistical period (2024.07.06-07.12), there were 6 newly accepted applications for consistency evaluation, involving 6 varieties, including 1 tablet and 5 injections. Compared with the previous statistical period, the number of varieties passing the consistency evaluation decreased by 2.
Status of Consistency Evaluation Varieties Passing the Evaluation
Sodium Cefuroxime for Injection
HeadCefuroxime Sodium was developed by GSK Plc and first launched in the UK, Ireland, Germany, and Italy in 1978. It was approved by the FDA in 1988 and received NMPA approval for a generic version produced by Guangzhou Baiyunshan Pharmaceutical Factory in China in 1994. It is now sold in many countries and regions worldwide. Cefuroxime Sodium has the advantages of a broad antibacterial spectrum, low renal toxicity, and strong permeability. Its main therapeutic areas include the gastrointestinal system, genitourinary system, respiratory system, nervous system, musculoskeletal system, inflammation, infections, and other miscellaneous conditions.
According to the data research by PharmaBlock, cefuroxime sodium available in the Chinese market is mainly divided into five major dosage forms: injections, tablets, oral liquid preparations, capsules, and granules. Among these, injections account for over 80% of the overall market share, indicating fierce market competition.According to the Generics Database survey by PharmaDJ, there are 303 drug approval numbers for Cefuroxime Sodium for Injection produced in China, with nearly 80 manufacturers, including Kelun Pharmaceuticals, Luoxin Pharmaceuticals, Qilu Pharmaceuticals, CSPC, and Furen Pharmaceuticals.
Due to space limitations, only the progress of the first five companies' applications is shown. For more information, please check Pharma Data.-Generic Drug Library
PharmCube Data - Information from the China Registration Database shows that the application landscape for cefuroxime sodium for injection in China is "41+3," and the evaluation landscape is "33+0." The companies that have passed the evaluation mainly include: “the first company to pass the evaluation” - Zhejiang Huidisen Pharmaceutical, Shandong Runze Pharmaceutical, Salubris Pharmaceuticals, Guangzhou Baiyunshan Tianxin Pharmaceutical, Sinopharm Zhijun, Qilu Pharmaceutical, etc., totaling 33 companies. The specific evaluation information is as follows:Summary of Sodium Cefuroxime for Injection Approval Information (Partial)
The production applications of other companies are still in the approval process.
Acceptance Status of the Consistency Evaluation Application for Cefuroxime Sodium for Injection (Partial)
Acceptance Status of the New Registration and Classification Declaration for Cefuroxime Sodium for Injection(Partial)
Pharmacodia Data - China Sales Database statistics show that the annual sales of Cefuroxime Sodium for Injection exceeded 2.3 billion yuan in 2023, with Guangzhou Baiyunshan Tianxin Pharmaceutical, Zhejiang Huidisen Pharmaceutical, and Salubris Pharmaceuticals ranking as the top three market leaders.
Cephalosporins are currently the largest class of antibiotics in terms of industrial scale, with five generations of products. From the current market share perspective, second and third-generation cephalosporins are the mainstream products. Cefuroxime, as a second-generation cephalosporin, is a therapeutic drug recommended by numerous guidelines and is also used for prophylaxis during the perioperative period. The "National Guidelines for Clinical Use of Antibacterial Drugs" primarily recommends second-generation cephalosporins for preventive use, indicating broad clinical prospects.
Status of Approval for Generic Drug Clinical Trials
Status of Rejection/Active Withdrawal of Generic Drug Varieties Development and Application Trends of Generic Drugs in China
Status of New Registration Classification Product Applications for Market LaunchAccording to the PharmaBlock data research, the current statistical period ((2024.07.06-07.12) Newly added 155 new application acceptance numbers under the new registration classification, involving 101 varieties, including 37 tablets, 39 injections, 3 oral solutions, 1 spray, 1 liniment, 4 eye drops, 2 inhalation solutions, 7 capsules, 1 oral emulsion, 1 cream, 1 inhalation powder, 1 ointment, and 1 granule.1One fine granule, one gel. Compared with the last statistical period, 21 new registered classification application varieties have been added this time.
Status of Application Acceptance for New Registration Categories (Partial)
Status of Consistency Evaluation Product Submissions for Market ApprovalAccording to the PharmCube data research, in this statistical cycle (2024.07.06-07.12), there were 15 newly accepted application numbers for consistency evaluation, involving 9 varieties, including 4 injections, 4 tablets, and 1 capsule. Compared with the previous statistical cycle, there is 1 less variety declared for consistency evaluation in this cycle.
Acceptance Status of Consistency Evaluation Applications (Partial)
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 on Protected Traditional Chinese Medicine Varieties(No. 18) (No. 80, 2024)
According to the Regulations on the Protection of Traditional Chinese Medicine Varieties, the National Medical Products Administration has approved Compound Furong Effervescent Suppositories produced by Shaanxi Maomaitde QiXueHe Pharmaceutical Co., Ltd. as the first TCM second-level protected variety. The protection variety number is: ZYB2072024007, with a protection period of seven years from the date of this announcement.
Hot News in China's Generic Drug R&D FieldHengrui Medicine: Hengrui Medicine's Announcement on Obtaining FDA Approval in the United States
On July 2, Jiangsu Hengrui Medicine Co., Ltd. announced that it had recently received a notification from the U.S. Food and Drug Administration (FDA) stating that the Abbreviated New Drug Application (ANDA) for the company's Bupivacaine Liposome Injectable Suspension has been approved. The company is the first manufacturer to receive approval for this generic drug in the United States. The relevant details are announced as follows:
1. Main Contents of the "Drug Registration Certificate"1. Basic Information of the DrugDrug Name: Bupivacaine Liposome Injectable SuspensionSpecification: 133mg/10mL, 266mg/20mLApplicant: Jiangsu Hengrui Medicine Co., Ltd.II. Other Information about the DrugBupivacaine is an amide-type local anesthetic widely used in clinical settings for local anesthesia and postoperative pain relief. Compared to the 5 to 6 hours of action provided by regular injections, bupivacaine liposome injectable can extend the analgesic effect to several days. It utilizes an advanced multi-vesicular liposome drug delivery system, offering excellent sustained-release properties, which are more beneficial for pain management in surgical patients, thereby improving their quality of life. Bupivacaine liposome injectable was first developed by the American company Pacira and was approved for marketing in the United States in 2011 under the trade name Exparel. Currently, it is only sold in the United States and Europe and has not yet been imported into China. Due to its high technical barriers, no generic products have successfully entered the market in over a decade after its launch. The company’s bupivacaine liposome injectable has undergone comprehensive in vitro evaluations and necessary in vivo evaluations, ensuring consistency in quality and efficacy with the original product. It was approved for marketing in China in December 2022 under Registration Category 3 and is considered to have passed the generic drug consistency evaluation.According to the inquiry, the global sales of bupivacaine liposome-related formulations in 2023 were approximately US$538 million. As of now, the cumulative R&D expenses for bupivacaine liposome injection-related projects have reached about 66.14 million yuan.3. Impact on the Company and Risk AlertsThe approval of bupivacaine liposome injectable suspension by the U.S. FDA will positively impact the company's market expansion. The company will actively promote the preparations for the drug's launch in the U.S. market.
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