Breakthrough Surge: 31 New Drugs Filed for Marketing Approval in China, Including Innovations from Hengrui, Kelun Biotech, and CSPC

In September this year, the submission of new drug applications for marketing in China witnessed a major surge.

According to the Insight database, as of September 29, a total of 31 new drugs submitted marketing applications to the NMPA this month.(Including new indications, excluding original research and localized varieties), the second-highest number in a single month this year. Among them, there are 14 domestically produced drugs and 17 imported drugs. In terms of drug types, there are 14 chemical drugs and 17 biologics.

According to the registration information in China, among the 31 drugs,Seventeen new drugs were submitted for marketing approval for the first time, including 11 Class 1 new drugs.This article will introduce information on several new drugs that have been reported for production for the first time.

Hengrui Pharma: HRS9531

The First China-Produced GLP-1R/GIPR Dual Agonist

On September 2, Hengrui Pharma's HRS9531 Injection received marketing application approval, indicated for use in conjunction with diet control and increased exercise.For Long-term Weight Management in Adults, the patient's initial Body Mass Index（BMI）≥28 kg/m²²(Obesity) or ≥24 kg/m²(Overweight) and have at least one weight-related comorbidity.

Screenshot source: CDE official website

HRS9531 is a dual agonist that simultaneously targets GLP-1R and GIPR. In July 2025, the Phase III clinical trial of HRS9531 injection will commence.（HRS9531-301）Achieved success. The study results showed that the HRS9531 group was significantly superior to the placebo group in the primary efficacy endpoint and all key secondary efficacy endpoints.HRS9531 High-Dose Group Average Weight Loss Reached 19.2%, with 44.4% of Subjects Losing ≥20% of Their Body Weight, and it has good safety and tolerability.

Insight database shows that, in the GLP-1R/GIPR dual-target new drug track, currently only Eli Lilly's tirzepatide has been approved for marketing globally. Hengrui Pharma's HRS9531 is the first domestically produced GLP-1R/GIPR dual agonist to be submitted for marketing. In addition, several other drugs with the same target have entered Phase III clinical trials in China, from Hansoh Pharma, BrightGene Bio-Medical, Amgen, Zhenong Pharmaceutical, and Huadong Medicine.

CORXEL/LENZ: Aceclidine Hydrochloride Eye Drops

First Presbyopia Eye Drops

On September 9, the marketing application for CORXEL and LENZ Therapeutics' Aceclidine Hydrochloride Eye Drops was accepted, with the indication for...Presbyopia(commonly known as presbyopia)。

Screenshot source: CDE official website

LNZ100 (Aceclidine Hydrochloride) is a LENZ Therapeutics-developed eye drop based on aceclidine, primarily used to improve near vision in patients with presbyopia.CORXEL has the exclusive rights to develop and commercialize LNZ100 in Greater China.

On July 31 this year, LNZ100 was approved for marketing in the United States.Became the first approved eye drop for presbyopia. In China, LNZ100(1.75% Aceclidine)Phase III Clinical Study JX07001 for the Treatment of Presbyopia Patients in China Has Been Successful.

China Phase III study data show that LNZ100 met the primary endpoint and key secondary endpoints, including near vision with best distance correction. (BCDVA) Three lines or more of significant improvement, maintaining best-corrected visual acuity(i.e., visual acuity decline must not exceed 5 letters). And most of the subjectsLNZ100 takes effect within 30 minutes after administration and its efficacy lasts for 10 hours.。

Alphamab Oncology/Shijiazhuang Pharmaceutical Group: Anitumab

The First China-Produced HER2 Bispecific Antibody

On September 12, the marketing application for Anitumab Injection submitted by Alphamab Oncology and Jinmantuo Biologics (a subsidiary of CSPC) was accepted, indicated for use inSecond-line Treatment for HER2-positive Locally Advanced, Recurrent, or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma. The application has been included in the priority review.

Screenshot source: CDE official website

KN026 is a HER2 bispecific antibody independently developed by Alphamab Oncology. In August 2021, Jinmate Biologics, a subsidiary of CSPC Group, reached a RMB 1 billion licensing collaboration with Alphamab Oncology, obtaining exclusive development and commercialization rights for KN026 in breast cancer and gastric cancer indications in mainland China.

Results from the Phase II clinical study presented at the 2024 ESMO Congress showed:KN026 Combined with Chemotherapy Shows an Objective Response Rate of 40.0%`, as reviewed by the Independent Review Committee` (IRC) AssessmentThe median progression-free survival was 8.6 months, and the median overall survival was 13.2 months.。

This marketing application is primarily based on a pivotal Phase II/III clinical trial.（KC-WISE）The first interim analysis results of the Phase III study showed that: compared with the current standard treatment, KN026 combined with chemotherapy significantly improved clinical efficacy, extended PFS and OS, with no new safety risks, low incidence of cardiac toxicity, and low immunogenicity.

According to the Insight database, currently in China, only BeiGene's Zenidatamab, a HER2 bispecific antibody introduced from Zymeworks, has been approved for marketing, for the treatment ofBiliary Tract CancerAlphamab Oncology and CSPC's KN026 is the first domestically produced HER2 bispecific antibody to be submitted for marketing in China, with the initial indication beingGastric Cancer。

Kelun Botai: Lunbotinib

First China-produced RET Inhibitor

On September 22, the marketing application for Kolonbotai's Fumarate Lunbotinib Capsules was accepted, indicated for the treatment ofRET Fusion-PositiveLocally Advanced or MetastaticNon-Small Cell Lung Cancer (NSCLC) Adult patients.Previously, only two imported RET inhibitors had been approved in China.Lunbotinib Is the First Chinese-Produced RET Inhibitor Submitted for Market Approval。

Screenshot source: CDE official website

Lenperitini（A400）It is a novel next-generation selective RET inhibitor being developed for the treatment of NSCLC, medullary thyroid carcinoma, and other solid tumors with high prevalence of RET alterations, with the potential to overcome resistance to first-generation selective RET inhibitors.

This marketing application is based on the positive results from two pivotal Phase II cohorts in the KL400-I/II-01 study, treating first-line and second-line or higher RET fusion-positive NSCLC. The data show that both pivotal clinical study cohorts have met the primary efficacy endpoint.The ORR for first-line treatment of RET+ NSCLC is 80.8%, and the ORR for second-line and above late-stage RET+ NSCLC is 69.7%.At the same time, Lenzolotinib also demonstrated manageable tolerability and safety.

In March 2021, Kelun-Biotech granted Ellipses Pharma in the UK exclusive rights for the development, manufacturing, and commercialization of Lenbotinib outside Greater China and certain Asian countries.(Development code: EP0031)Overseas, Lumibotinib has been granted Fast Track designation by the U.S. FDA for the treatment of RET fusion-positive NSCLC and is currently undergoing clinical trials in the United States, the United Kingdom, the European Union, and the United Arab Emirates.

SALUBRIS: Tacticumab

The 5th China-produced PCSK9 monoclonal antibody

On September 19, the marketing application for Taikasiranib Injection by Salubris was accepted, with the indication beingFor HypercholesterolemiaAndMixed DyslipidemiaThis is the 5th domestically produced PCSK9 monoclonal antibody to be reported for production in China.

Screenshot source: CDE official website

Currently, seven PCSK9-targeted therapies have been approved in China. Among them, only Novartis' Inclisiran is an siRNA, while the other six are PCSK9 monoclonal antibodies from Amgen, Sanofi, Innovent, Akeso, Junshi, and Hengrui Pharma, respectively. Notably, due to a global shortage of raw material supplies, as well as strategic optimizations for the cardiovascular market pipeline, Sanofi will discontinue Praluent.(Alirocumab)Promotion in the Chinese market, and will gradually exit the Chinese market.

SALUBRIS ANNOUNCES THAT FOR PCSK9 MONOCLONAL ANTIBODIES CURRENTLY MARKETED IN CHINA, IF ADMINISTERED ONCE EVERY 4 WEEKS VIA SUBCUTANEOUS INJECTION, 2-3 INJECTIONS OR ASEPTIC PREPARATION ARE REQUIRED. HOWEVER, TACASELIMAB ALSO REQUIRES SUBCUTANEOUS INJECTION ONCE EVERY 4 WEEKS.But only one injection at a time`, which is expected to significantly improve patient medication convenience and treatment adherence.`

ZhiXiang JinTai: Talizumab

The 3rd IL-4Rα Monoclonal Antibody Produced in China

On September 11, Zhi Xiang Jin Tai Telecizumab（GR1802）Marketing application for the injection accepted, with indications forModerate to Severe Atopic Dermatitis. This is the third domestically produced IL-4Rα monoclonal antibody to be reported.

Screenshot source: CDE official website

GR1802 for the Indication of Moderate to Severe Atopic Dermatitis Has Reached the Primary Efficacy Endpoint in Phase III Clinical Trials. In addition to atopic dermatitis,GR1802 Phase III clinical trials are currently underway for indications including chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, adult seasonal allergic rhinitis, and adolescent seasonal allergic rhinitis.

According to the Insight database, there are currently two IL-4Rα monoclonal antibodies approved globally: Dupilumab from Sanofi/Regeneron and Spesolimab from Conxima/Jinmante Biologics. Among them, Dupilumab was the world's first approved IL-4Rα monoclonal antibody, with global sales reaching $14.089 billion in 2024 and €7.312 billion in the first half of 2025.(Approximately 8 billion USD)。

In China, apart from the already approved Dupilumab and Spesolimab, Ledebebant (by Connect Biopharma/Simcere) and Talibebant (by Zhi Xiang Jin Tai) have been submitted for marketing approval. Additionally, seven other products are currently undergoing Phase III clinical trials, developed by companies such as CT Tianqing/BioShin, Hengrui Pharma, Akeso, QuanXin Bio, 3SBio, MagiBio, and Qilu, making the competition extremely intense.

Fosun Pharma: Brexucabtagene Autoleucel

The Second CAR-T Product Submitted for Marketing Approval

On September 24, Fosun Karry (Fosun Caribou)(Formerly known as Fosun Kite)The marketing application of Brexucabtagene Autoleucel Injection has been accepted, with the indication for relapsed or refractory precursor B-cell acute lymphoblastic leukemia.（ALL）Adult patients.

Source: CDE Official Website

Brexucabtagene Autoleucel（Brexucabtagene autoleucel、KTE-X19）Developed by Kite Pharma, a subsidiary of Gilead SciencesA CAR-T Cell Therapy Targeting CD19Previously, the drug has been approved for marketing in countries and regions such as the United States, the European Union, and Canada, for the treatment of mantle cell lymphoma and B-cell acute lymphoblastic leukemia.（B-ALL）。

Fosun Karry owns the rights to Brexucabtagene Autoleucel in mainland China, Hong Kong, and Macao, and is currently conducting a single-arm Phase II clinical trial in mainland China for the treatment of mantle cell lymphoma and B-ALL.In June this year, Fosun Kite announced the latest results of the bridging registration clinical study of KTE-X19 in Chinese R/R B-ALL patients., the primary endpoint of the trial was centrally assessedCR/CR with incomplete hematologic recovery（CRi）Rate。

As of October 28, 2024, a total of 28 patients had received KTE-X19 reinfusion.（1×10^⁶CAR-T cells/kg)。Efficacy data show:At a median follow-up of 8.1 months, the CR/CRi rate was 78.6%.; Median DOR, median RFS, and median OS were not reached,All respondents' MRD test results were negative.（100%）。Safety data show that no new safety signals were observed in the Chinese population.

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