Global Drug Approvals/R&D UpdatesGlobal New Drug ApprovalsAccording to the PharmaDJ data analysis, during this statistical period (September 13-19, 2025), there were 15 updates on new drug approval statuses globally (excluding China). Among these, there were 7 NDA approvals, 2 BLA approvals, 5 new indication approvals, and 1 new formulation approval. Compared with the previous statistical period, this cycle saw an increase of 9 globally approved drugs and a decrease of 1 drug that was rejected, voluntarily withdrawn, or removed from the market.
On September 15, Novo Nordisk announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) had approved an update to the label of Rybelsus (oral semaglutide) to reflect the cardiovascular benefits confirmed in the SOUL trial. SOUL is a Phase IIIb clinical study designed to evaluate the impact of Rybelsus on cardiovascular outcomes in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). The study results showed that adding oral semaglutide to standard treatment significantly reduced the risk of major adverse cardiovascular events (MACE) by 14% compared to placebo.On September 19, Shanghai Henlius Biotech, Inc. and Organon jointly announced that the European Commission (EC) had approved the marketing authorization for denosumab injection BILDYOS® (60mg/mL) and BILPREVDA® (120mg/1.7mL). The two products are biosimilars of PROLIA® and XGEVA®, respectively, covering all indications approved in the EU for the originator products. Studies have shown that BILDYOS and BILPREVDA are highly similar to the EU-approved originator products in terms of structure, biological activity, efficacy, safety, and immunogenicity profiles (the ability of proteins and other biologics to induce immune responses or immune-related events).New Drug Approvals Worldwide (Excluding China) (Partial)
Global New Drug Submission ProgressAccording to the PharmaDJ data analysis, during this statistical period (September 13-19, 2025), there were 2 new drug application progress updates globally (excluding China). Among them, there were 2 biologic drug application progress updates. Compared with the previous statistical period, there was a decrease of 4 NDA/BLA application progress updates in this period.
On September 19, MSD announced that the EMA's Committee for Medicinal Products for Human Use recommended the approval of ENFLONSIA™ (Clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. ENFLONSIA can provide direct, rapid, and lasting protection throughout the RSV season (typically five months), with the same dose used regardless of the infant's weight.According to the PharmaDJ data analysis, during this statistical period (September 13-19, 2025), a total of six drugs (excluding China) worldwide received special regulatory designations. Among them, there was one chemical drug, four biologics, and one cell therapy. The number of drugs receiving special regulatory designations during this statistical period remained the same as the previous period.
On September 15, MSD and Daiichi Sankyo jointly announced that their co-developed investigational antibody-drug conjugate (ADC), Raludotatug deruxtecan (R-DXd), had been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of adult patients with platinum-resistant CDH6-positive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have received prior treatment with Bevacizumab. Analysis showed that in heavily pretreated advanced ovarian cancer patients, the drug achieved an overall response rate of 46%, a disease control rate of up to 98%, and a median duration of response of 11.2 months.On September 16, Akeso Biopharma announced that the FDA had granted its next-generation anti-CD47 humanized IgG4 monoclonal antibody, Lifarlimab (AK117), Orphan Drug Designation (ODD) for the treatment of Acute Myeloid Leukemia (AML). Preclinical studies have shown that when used in combination with azacitidine or venetoclax, Lifarlimab can synergistically enhance the expression of "eat-me" signals (such as calreticulin), thereby more effectively activating phagocytic immune responses. Clinical studies have demonstrated that the combination of Lifarlimab and azacitidine is well-tolerated and has shown encouraging efficacy in first-line treatment of AML: it was well-tolerated at doses up to 45mg/kg administered once every two weeks, with no significant safety differences observed between groups. The complete response (CR) rate at the target dose reached 50.0%, and the composite complete response (cCR) rate was as high as 55.0%.Drugs Granted Special Status by Global Regulatory Agencies
Global New Drug Development ProgressAccording to the PharmaDJ data statistics analysis, during this statistical period (September 13-19, 2025), there were a total of 136 updates on the global (excluding China) new drug clinical R&D status, involving oncology, neurological diseases, infectious diseases, and cardiovascular conditions.A total of 17 fields, including diseases.Among them, the clinical progress updates in the field of oncology ranked first among all fields, with 27 updates, including 11 for chemical drugs, 13 for biologics, 1 for cell therapy, and 2 for vaccines.On September 15, Shanghai Henlius Biotech, Inc. announced the latest data results for the Asian population from the final analysis of the study on Hansizhuang® (Seriulimab) combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), which was presented for the first time at the 28th CSCO Conference: With a median follow-up time of 43.6 months, Seriulimab combined with chemotherapy demonstrated consistent clinical benefits in OS, PFS, ORR, and DOR results, showing more significant anti-tumor activity compared to chemotherapy alone — the median OS in the Seriulimab group reached 15.8 months, an improvement of 4.7 months over the chemotherapy group, with a 4-year OS rate of 22.4%, the highest reported among similar drugs.On September 17, Ascletis announced the presentation of results from Cohort 1 and Cohort 2 of its ASC30 Multiple Ascending Dose (MAD) study at the 61st EASD Annual Meeting. In MAD Cohort 2 (2mg, 10mg, 20mg, and 40mg, with weekly dose escalation), once-daily oral ASC30 tablets demonstrated an average weight loss of 6.5% after 28 days of treatment. In MAD Cohort 1 (2mg, 5mg, 10mg, and 20mg, with weekly dose escalation), once-daily oral ASC30 tablets demonstrated an average weight loss of 4.5% after 28 days of treatment. No signs of a weight loss plateau were observed on Day 29, and safety and tolerability were good.Global New Drug Development Progress Details (Partial)
Global Pharmaceutical Transaction EventsThis statistical cycle（2025.09.13-09.19）There were a total of 30 pharmaceutical transaction events globally (including China), involving drug rights transfers, company acquisitions, and other transaction events.
Summary Table of Global Pharmaceutical Transaction Times (Partial)
Drug Approval/Development Updates in ChinaNew Drug Approvals in ChinaAccording to the PharmCube data statistics analysis, the statistical period for this report (2025.09.13-09.19)In China, a total of 4 new drugs were approved for marketing by the NMPA, including 1 vaccine approval and 3 new indication approvals. Compared with the previous statistical cycle, this time there are 2 more new drugs approved by the NMPA.
On September 9, Fosun Pharma announced that the supplemental drug registration application for Citrate Voruciclib Capsules has been approved by the NMPA. The approved indication is for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) locally advanced or metastatic breast cancer: in combination with aromatase inhibitors as initial endocrine therapy. Studies have shown that this new drug can significantly prolong the median progression-free survival of patients, reduce the risk of disease progression, and maintain overall controllable safety.On September 19, Innovent Biologics announced that the second indication of Mazdutide Injection had been approved by the NMPA for glycemic control in adult patients with type 2 diabetes. Studies have shown that Mazdutide is superior to placebo or Dulaglutide 1.5mg in both glycemic control and weight reduction, while also demonstrating improvements in multiple cardiometabolic, liver, and kidney-related indicators. The safety profile of Mazdutide is consistent with previous clinical studies and other GLP-1R agonists, with no new safety risks identified. This is the world's first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, offering potential benefits for a large population of diabetic patients in China by achieving glycemic control, weight loss, and improvements in liver, heart, and kidney indicators.New Drug Approvals in China (Partial)Progress of Clinical Implied Consent for New Drugs in ChinaAccording to the statistical analysis of PharmaDJ data, the statistical cycle for this period is (2025.09.13-09.19).) A total of 48 new drugs received clinical tacit approval in China, involving 79 application numbers.Among them, 20 are chemical drugs and 28 are therapeutic biological products.Compared with the last statistical period, this time there are 21 additional clinical tacit approval acceptance numbers granted.
This Week's Progress on Clinical Trial Approvals for New Drugs in China (Partial)
Progress of New Drug Applications in ChinaAccording to the PharmaBlock data analysis, during this statistical period (September 13-19, 2025), a total of 8 new drug applications were submitted for marketing in China, involving 13 acceptance numbers. Among them, there were 4 chemical drugs and 4 therapeutic biological products. Compared with the previous statistical period, this period saw an increase of 4 acceptance numbers for new drug applications.。
New Drug Marketing Applications in China (Partial)According to the data analysis by PharmaDJ, during this statistical period (September 13-19, 2025), a total of 35 new drugs applied for clinical trials in China, involving 53 application numbers. Among them, there were 16 chemical drugs, 17 therapeutic biological products, and 2 preventive biological products. Compared with the previous statistical period, the number of accepted clinical applications decreased by 36.
Clinical Trial Applications for New Drugs in China (Partial)According to the PharmaBlock data statistics analysis, the statistical cycle for this period (2025.09.13-09.19)China Adds 7 NewNMPADrugs granted special qualification designation. Among them, 2 are chemical drugs and 5 are biologics. Compared to the last statistical cycle, this round adds 5 drugs granted special qualification designation by the NMPA.
On September 17, according to the announcement on the CDE’s official website, Hengrui Medicine's Class 1 new drug, SHR-1501 Injection, is proposed to be included in the breakthrough therapy designation. The proposed indication is: SHR-1501 in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle-invasive carcinoma in situ (CIS). Research results show that, as of September 7, 2024, a total of 84 patients were enrolled (Phase Ia: 8 patients; Phase Ib: 6 patients; Phase 2 Cohort A/B/C: 29, 17, and 24 patients, respectively). The Phase 2 study adopted a regimen of 600μg SHR-1501 combined with 120mg BCG. Among them, the evaluable patients in Cohort B showed a complete response (CR) rate of 90.9% at 3 or 6 months, which is precisely the indication for SHR-1501's proposed inclusion in the breakthrough therapy designation this time.On September 19, according to the announcement on the CDE official website, MRG003 (Vebecotamab for Injection) developed by LePu BioPharma is proposed to be included in the breakthrough therapy designation. It will be used in combination with HX008 (Prolilimab Injection) to treat recurrent or metastatic nasopharyngeal carcinoma that has failed at least platinum-based and PD-1/L1 treatments. Data shows that the clinical trial reached the primary endpoint of ORR. The ORR of the MRG003 treatment group and the chemotherapy control group were 30.2% and 11.5%, respectively, increasing nearly threefold. The DCR was 77.9% and 56.3%, respectively, meaning the proportion of patients with disease progression was reduced by half. For the primary endpoint PFS, the mPFS of the MRG003 treatment group and the chemotherapy control group were 5.82 months and 2.83 months, respectively, doubling the result, with a 37% reduction in the risk of disease progression or death.
NMPAProgress in Special Drug DesignationProgress in New Drug Development in ChinaAccording to the PharmaBlock data analysis, during this statistical period (September 13-19, 2025), there were a total of 13 updates on the clinical development status of new drugs in China, covering nine fields including oncology, hematology and lymphatic diseases, neurological disorders, and nutritional and metabolic diseases. Among them, six are chemical drugs, four are biologics, and three are cell therapies. Compared with the previous statistical period, there are two fewer updates on the clinical development status of new drugs in China.
On September 15, Antorna Bio announced that its ART104 drug had completed the first patient dosing in an investigator-initiated clinical trial (IIT) on September 1, 2025, with the patient experiencing no discomfort throughout the process. The first follow-up visit after administration has been completed, and no drug-related side effects were found during the evaluation, indicating good safety. ART104 is a potential "first-in-class" antisense oligonucleotide (ASO) drug designed to treat Alagille syndrome (ALGS) by addressing its genetic root cause. ART104 is the first ASO therapeutic drug aimed at upregulating Jag1 protein expression. By directly addressing the issue of insufficient Jag1 protein levels, ART104 has the potential to fundamentally change disease outcomes for ALGS patients and their families.On September 19, Icarus Bio announced the official release of the 36-month long-term follow-up data from the FUMANBA-1 study on Fokosu® (Eque-cel, Idecabtagene Vicleucel) for the treatment of relapsed/refractory multiple myeloma (R/R MM) during the annual meeting of the International Myeloma Society (IMS). Among 107 evaluable patients, the ORR was 96.3%, with a CR or sCR rate of 83.2%. In CAR-T-naïve patients, the ORR and CR/sCR rates were 98.9% and 88.4%, respectively. The median PFS in 109 patients treated with Eque-cel was 30.5 months, extending to 35.9 months in CAR-T-naïve patients. The median OS has not yet been reached. Of the evaluable patients, 95.3% achieved minimal residual disease (MRD) negativity, including all patients who achieved CR or sCR, with a median duration of MRD negativity of 36.5 months. Long-term safety was manageable.Progress in New Drug Development in China (Partial)
Policy and Regulatory Updates in China's New Drug Development FieldNotice on Publicly Soliciting Opinions for the "Technical Guidelines for Pharmaceutical Research of Vaccine Adjuvants for Preventive Use (Draft for Comments)"To better guide the research and evaluation of vaccines containing novel adjuvants and promote the development of innovative adjuvants and vaccines, our center has organized the drafting of the "Technical Guidelines for Pharmaceutical Research on Preventive Vaccine Adjuvants (Draft for Comments)" after extensive investigation and discussion.We sincerely welcome valuable opinions and suggestions from all sectors of society on the draft for comments, and please feedback to us in a timely manner for subsequent improvement. The comment solicitation period is 1 month from the date of publication.Hot News in China's New Drug Development FieldMabwell Biotech, Unconventional PathMabwell Writes the Most Vivid Footnote for Its "Differentiation Strategy" with the Latest Pipeline Progress.On September 1, the Phase II study of IL-11 monoclonal antibody 9MW3811 for pathological scars was accepted by the NMPA, becoming the world’s first and only IL-11 targeted drug to enter the clinical stage in this indication; On September 12, the new Alzheimer's disease drug MWTX-4611 was approved for clinical trials in China for the first time. Both pipelines are aimed at unmet clinical needs.However, this is merely the tip of the iceberg of its differentiation strategy… The share price of Mabwell Biotech has surged over 140% year-to-date, already reflecting the expectations of the capital market.Pharmaceuticals + Medical Aesthetics: The Diversification Ambitions of Huadong MedicineIn the Wave of Change in the Pharmaceutical Industry, Huadong Medicine's Transformation Path is Quite Representative. In the first half of 2025, Huadong Medicine achieved a 3.39% increase in revenue and a 7.01% growth in net profit attributable to shareholders. However, beneath the seemingly stable growth curve, the income from its innovative product business surged 59% year-on-year, with R&D investment increasing by 33.75%, showcasing the firm determination of traditional pharmaceutical companies to transform towards innovation-driven growth. This enterprise, known as "China's Big White Horse in the Pharmaceutical Industry," is exploring new growth logic amid industry changes through the dual drivers of innovative drugs and medical aesthetics businesses.Self-developed and Introduced Go Hand in HandHuadong Medicine's innovative drug transformation achieved numerous breakthroughs by 2025.From the perspective of the R&D pipeline, Huadong Medicine's innovative research and development focuses on three core therapeutic areas: oncology, endocrinology, and autoimmune diseases. The number of pipeline projects has now exceeded 80, placing it in the top tier of China's pharmaceutical industry.More information, read the original textLittle D Has Something to Say
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