Global Drug Approvals/R&D UpdatesGlobal New Drug ApprovalsAccording to the data analysis by PharmaDJ, during this statistical period (March 29, 2025 - April 4, 2025), a total of 6 new drugs were approved for marketing globally (excluding China). Among them, there was 1 NDA approval, 1 BLA approval, and 4 new indication approvals. Compared with the previous statistical period, there were 5 fewer drug approvals in this cycle.'%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)
On April 3, Amgen announced that the FDA had approved UPLIZNA for the treatment of adult patients with Immunoglobulin G4-Related Disease (IgG4-RD). During the 52-week placebo-controlled trial, the risk of IgG4-RD flares was reduced by 87% compared to placebo. Among participants receiving UPLIZNA, 57.4% achieved flare-free, treatment-free, and complete remission at week 52, and 58.8% achieved flare-free, corticosteroid-free, and complete remission at week 52. Additionally, 89.7% of patients did not require glucocorticoid therapy to control the disease, and the average total glucocorticoid usage for disease control among patients treated with UPLIZNA decreased tenfold.On April 4, Novartis announced that the FDA had granted accelerated approval for Vanrafia (Atrasentan) to reduce proteinuria levels in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. Data showed that patients receiving Vanrafia in combination with RAS inhibitors achieved a clinically meaningful and statistically significant reduction in proteinuria of 36.1% (P<0.0001) compared to the placebo group. This effect was observed as early as week 6 and sustained through week 36. The impact of Vanrafia was consistent across all subgroups.New Drug Approvals Worldwide (Excluding China) (Partial)
Global New Drug Submission ProgressAccording to the statistical analysis by PharmaDJ, during this statistical period (March 29, 2025 - April 4, 2025), there were a total of 9 new drug applications for marketing approval globally (excluding China). Among them, there were 4 NDA submissions, 4 BLA submissions, and 1 vaccine submission. Compared with the previous statistical period, this period saw an increase of 5 NDA/BLA submissions.。On March 31, BeOne Medicines announcedEMARecommend Approval of BeOne Medicines®(Tislelizumab,TEVIMBRA®) Combined with etoposide and platinum-based chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) as first-line treatment. Studies show that the median of Tislelizumab combined with chemotherapyOSFor15.5Months, reduced risk of death25%, generally well tolerated, with no new safety signals detected.NDA/BLA Submission (Partial)According to the PharmaBlock data statistics analysis, during this statistical period (March 29, 2025 - April 4, 2025), a total of 2 drugs (excluding China) worldwide received special regulatory designations. Among them, there were 2 chemical drugs. Compared with the previous statistical period, the number of drugs receiving special regulatory designations decreased by 2.On April 2, Biogen announced that the FDA had granted BIIB080 Fast Track designation for the treatment of Alzheimer's disease. BIIB080 is the first antisense oligonucleotide (ASO) drug targeting Tau protein to enter clinical development for Alzheimer's disease and is currently being evaluated in the global Phase II CELIA study involving patients with early-stage disease. Results from the Phase Ib study showed a dose-dependent reduction in soluble Tau protein levels in cerebrospinal fluid (CSF), a decrease in aggregated Tau pathology in the brain as detected by PET imaging, and favorable trends in exploratory clinical outcomes. In the high-dose group, positive trends were observed across multiple exploratory measures of cognition and function.On April 3, Sanofi announced that the FDA had granted Rilzabrutinib orphan drug designation for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD). Results from the Phase IIb study in wAIHA demonstrated clinically meaningful efficacy with Rilzabrutinib in terms of response rates and disease markers; in IgG4-RD patients, Phase IIa study results showed that 52 weeks of treatment with Rilzabrutinib reduced disease flares, lowered levels of other disease markers, and decreased the use of corticosteroids.Drugs Granted Special Status by Global Regulatory Agencies
Global New Drug Development ProgressAccording to the PharmaData statistical analysis, during this statistical period (March 29, 2025 - April 4, 2025), there were a total of 37 updates on the clinical development status of new drugs globally (excluding China), covering 11 fields including oncology, neurological diseases, endocrine system diseases, nutritional and metabolic disorders, and cardiovascular diseases.Among them, the clinical progress updates in the field of neurological diseases ranked first among all fields, with a total of 12 updates, including 6 for chemical drugs, 5 for biologics, and 1 for vaccines.On April 1, Merck evaluated the Phase III clinical trial results of Winrevair (Sotatercept) for the treatment of adult patients with high mortality risk pulmonary arterial hypertension (PAH). The data showed that at a median follow-up time of 10.6 months, Winrevair reduced the relative risk of major morbidity and mortality events by 76% compared to placebo. Among patients treated with Winrevair, 17.4% experienced one or more major morbidity and mortality events, compared to 54.7% in the placebo group. The safety profile of Winrevair in the trial was generally consistent with what was observed in previous studies.On April 1, AstraZeneca announced positive results from the Phase IIb clinical trial of its investigational therapy AZD0780. Compared with placebo, the use of AZD0780 on top of standard statin therapy significantly reduced patients' low-density lipoprotein cholesterol (LDL-C). At 12 weeks, adding AZD0780 to statin therapy reduced LDL-C by 50.7%, and AZD0780 helped 84% of participants achieve the LDL-C target (<70 mg/dL) recommended by the American Heart Association/American College of Cardiology guidelines.Global New Drug Development Progress Details (Partial)
Global Pharmaceutical Transaction EventsThis statistical cycle（2025.03.29-04.04）There were a total of 31 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 statistical analysis by PharmaDJ, the statistical period this time (2025.03.29-04.04)In China, a total of 6 new drugs were approved for marketing by the NMPA, including 1 NDA approval, 2 BLA approvals, 1 new compound approval, and 2 new indication approvals. Compared with the previous statistical cycle, this time there are 5 more new drugs approved by the NMPA.On March 31, Santen announced that its fixed-dose combination eye drop, Tafuprost and Timolol Maleate (brand name: TAPCOM®), used for glaucoma treatment, has been approved by the NMPA for marketing in China. This product is a preservative-free fixed-dose combination of 0.0015% tafuprost and 0.5% timolol maleate. It is intended to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension who respond inadequately to topical monotherapy with either β-blockers or prostaglandin analogs and may benefit from combination therapy or preservative-free eye drops. Once-daily administration provides equivalent efficacy and safety to combination therapies, improving patient convenience, compliance, and quality of life.Recently, Hengrui Medicine received the "Drug Registration Certificate" issued by NMPA, approving a new indication for Imecitinib Sulfate Tablets (Elsudar®) for adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF inhibitors. Imecitinib exhibits significantly lower inhibitory activity against JAK2 and JAK3, minimizing adverse reactions in the hematopoietic system such as anemia and thrombocytopenia. Study results show that Imecitinib Sulfate Tablets demonstrate good efficacy and safety, with once-daily dosing, convenient usage, which helps improve patient treatment adherence.New Drug Approvals in China
Progress of Implied Consent for New Drug Clinical Trials in ChinaAccording to the PharmaDJ data statistical analysis, the current statistical period (2025.03.29-04.04)) A total of 37 new drugs received clinical tacit approval in China, involving 51 application numbers.Among them, there are 15 chemical drugs, 20 therapeutic biological products, and 2 preventive biological products.Compared with the last statistical period, this time there was a reduction of 24 clinical tacit approval acceptance numbers.
Clinical Trial Approvals for New Drugs in China This Week (Partial)
Progress of New Drug Applications in ChinaAccording to the PharmaBlock data analysis, during this statistical period (March 29, 2025 - April 4, 2025), there were a total of 5 new drug marketing applications in China, involving 9 acceptance numbers. Among them, there were 5 therapeutic biological products. Compared with the previous statistical period, this time there was a reduction of 8 acceptance numbers for new drug marketing applications.。
New Drug Clinical Launch Status in ChinaAccording to the data analysis by PharmaDJ, during this statistical period (March 29, 2025 - April 4, 2025), there were 21 new drug clinical trial applications in China, involving 31 acceptance numbers. Among them, there were 6 chemical drugs, 14 therapeutic biologics, and 1 preventive biologic. Compared with the previous statistical period, the number of accepted clinical trial applications decreased by 37.
Clinical Trial Applications for New Drugs in China (Partial)According to the PharmaData statistical analysis, during this statistical period (March 29, 2025 - April 4, 2025), no drugs in China received special qualification designation from the NMPA. Compared with the previous statistical period, there was a decrease of four drugs receiving special qualification designation from the NMPA.。Progress in New Drug Development in ChinaAccording to the statistical analysis by PharmaDJ, during this statistical period (March 29, 2025 - April 4, 2025), there were a total of 3 updates on the clinical development status of new drugs in China, involving the fields of oncology, infectious diseases, and ophthalmic diseases. Among them, there were 2 biologics and 1 vaccine. Compared with the previous statistical period, this period saw an increase of 1 update on the clinical development status of new drugs in China.
On April 2, Henlius announced that the Phase III clinical study conducted in Chinese patients with wet age-related macular degeneration (wAMD) for HLX04-O, a recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody injection developed in collaboration with Ebio Biotech, has successfully achieved the pre-specified primary endpoint. The study results showed that the mean change in BCVA from baseline at week 48 in the HLX04-O group was non-inferior to the ranibizumab group, achieving the primary endpoint. The overall safety profile of HLX04-O and ranibizumab, including systemic, ocular, and non-ocular aspects, was similar and demonstrated good safety in wAMD patients.On April 3, BeOne Medicines announced the termination of the clinical development program for its anti-TIGIT antibody, Ociperlimab (BGB-A1217), as a potential treatment for lung cancer. Based on the results of a pre-planned futility analysis, the Independent Data Monitoring Committee recommended halting the ongoing Phase III AdvanTIG-302 trial. The overall efficacy and safety data evaluation indicated that the study might struggle to achieve the primary endpoint of overall survival. However, no new safety signals were identified.Progress in New Drug Development in China
Policy and Regulatory Updates in China's New Drug Development FieldNotice on Public Solicitation of Comments for the ICH "M11: Electronic Structured Harmonized Clinical Protocol" Technical Specification Draft
ICH《M11:Technical Specification Document for Electronically Structured Coordinated Clinical Protocols Enters Phase3Stage of regional public solicitation of opinions. According toICHRelevant Articles of Association require,ICHMembers of the regulatory authority need to collect opinions on the draft document from their region and provide feedback.ICH。
M11The English original and Chinese translation of the draft technical specification document are attached. The public is now invited to provide comments on the content of the guideline and its Chinese translation.
Hot News in China's New Drug Development Field
Lepu Biotech, Ambition Backed by StrengthAlthough Lepu Biotech is a young Biotech company, its product pipeline is not thin. After its establishment in 2018, through "mergers and acquisitions + introduction," it acquired Taizhou Hanzhong, Taizhou Aoke, and Shanghai Meiyake, bringing core pipelines such as PD-1 and ADC under its command, and introduced oncolytic viruses from CG Oncology to form the third business pillar.Over the past seven years, Leap Biologics has completed the commercialization of its first product, successfully listed on the Hong Kong Stock Exchange, and built an integrated industrial platform encompassing R&D, production, and commercialization. In 2024, losses remained flat, with cash equivalents at 426 million yuan, unchanged from the beginning of the year.For the future of Biotech, one must look far ahead. Fortunately, the realization of Lepu Biotechnology's potential won’t keep us waiting for long — its second blockbuster product, MRG003, is just one step away from hitting the market. At the upcoming ASCO Annual Meeting, MRG003’s Phase III data for advanced nasopharyngeal carcinoma has been successfully selected for BLA and will be presented in an oral report, building high anticipation.More information, read the original textBaili Tianheng Hones Its "Money-Making Techniques"The growth of Baili Tianheng has been astonishing. From 2023 to the present, in less than three years since its listing, its stock price has surged more than eightfold. When it first entered the capital market, Baili Tianheng was even shunned by some due to its overly "aggressive" R&D strategy. However, as early as 2010, being "daring" had already become one of Baili Tianheng's labels. The exorbitantly priced BD's BL-B01D1 is not particularly outstanding in Baili Tianheng's R&D pipeline; what truly stands out are those dazzling tetra-specific antibodies.Little D Has Something to Say
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