Global Drug Approvals/R&D UpdatesGlobal New Drug ApprovalsAccording to the data analysis by PharmaDJ, during this statistical period (July 26, 2025 - August 1, 2025), a total of 10 new drugs were approved for marketing globally (excluding China). Among them, one received NDA approval, and nine were approved for new indications. The number of newly approved drugs globally during this statistical period remained the same as the previous period.
On July 25, Novo Nordisk announced that the FDA had approved Alhemo (Concizumab) injection for the prevention or reduction of bleeding episodes in patients aged 12 years and older with Hemophilia A (HA) and Hemophilia B (HB) who do not have inhibitors. The approval was primarily based on results from a Phase III clinical trial, which demonstrated that Alhemo has a favorable safety and efficacy profile in HA/HB patients aged 12 years and older without inhibitors. The trial showed a 79% reduction in annualized bleeding rate (ABR) in HB patients without inhibitors, while the reduction in ABR was even higher in HA patients, reaching 86%.On July 31, Novartis announced that the FDA had approved the expanded indication application for its twice-yearly small interfering RNA (siRNA) therapy Leqvio (Inclisiran), allowing it to be used as a monotherapy in combination with diet control and exercise to reduce low-density lipoprotein cholesterol (LDL-C) levels in adult patients with hypercholesterolemia. As a monotherapy, Leqvio can significantly reduce LDL-C levels in moderate- and low-risk ASCVD patients. Analysis shows that compared with placebo and active control drugs, Leqvio monotherapy demonstrates superiority in reducing LDL-C levels in ASCVD patients, supporting Leqvio as a primary and secondary prevention drug for ASCVD. The characteristic of twice-yearly dosing of Leqvio may help improve patient treatment adherence.New Drug Approvals Worldwide (Excluding China) (Partial)
Global New Drug Submission ProgressAccording to the PharmaDJ data analysis, during this statistical period (July 26, 2025 - August 1, 2025), there were a total of 6 new drug application progresses globally (excluding China). Among them, there were 3 NDA applications and 3 BLA applications. Compared with the previous statistical period, there was a decrease of 7 NDA/BLA applications in this period.。7Month28Date, BeOne Medicines announcedEMA CHMPRecommend Approval of BeOne Medicines®(Tislelizumab) combined with platinum-based chemotherapy for resectable non-small cell lung cancer with high risk of recurrence (NSCLC) Preoperative neoadjuvant therapy for adult patients, followed by postoperative adjuvant therapy with tislelizumab monotherapy. The clinical study achieved event-free survival (EFS) at the interim analysis.EFS) and major pathological remission (MPR) These two primary endpoints, with good safety.
NDA/BLA Submission (Partial)According to the PharmaDJ data analysis, during this statistical period (July 26, 2025 - August 1, 2025), a total of 13 drugs worldwide (excluding China) received special regulatory designations. Among them, there were 6 chemical drugs, 6 biologics, and 1 cell therapy. Compared with the previous statistical period, the number of drugs receiving special regulatory designations increased by 4 in this period.
On July 28, AstraZeneca announced that Imfinzi had received priority review and breakthrough therapy designation in the United States for patients with resectable early-stage gastric cancer and gastroesophageal junction cancer. In the clinical trial, patients received neoadjuvant Imfinzi combined with chemotherapy before surgery, followed by adjuvant Imfinzi combined with chemotherapy, and then Imfinzi monotherapy. Compared with chemotherapy alone, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence, or death. It was estimated that 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free within one year; the estimated 24-month EFS rates were 67.4%, indicating greater benefits of the Imfinzi-based regimen over time.On July 29, Alphamab Oncology announced that JSKN003 has been granted Orphan Drug Designation by the FDA for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ). Compared with similar ADC drugs, JSKN003 demonstrates better serum stability and a stronger bystander killing effect. Clinical studies have shown that JSKN003 exhibits good tolerability and safety, with significant efficacy in various patients with advanced solid tumors who have previously undergone multiple lines of systemic anti-tumor therapy, particularly showing promising anti-tumor activity in gastrointestinal cancer patients with high HER2 expression. Currently, three Phase III clinical trials of JSKN003 for HER2-low breast cancer, platinum-resistant ovarian cancer, and HER2-positive breast cancer, as well as several exploratory Phase II clinical trials, are proceeding smoothly.Global Drugs Granted Special Status by Regulatory Authorities (Partial)
Global New Drug Development ProgressAccording to the PharmSnap data analysis, during this statistical period (July 26, 2025 - August 1, 2025), there were a total of 63 updates on the clinical development status of new drugs globally (excluding China), involving oncology, neurological diseases, infectious diseases, and cardiovascular conditions.A total of 14 fields, including diseases.Among them, the clinical progress updates in the field of neurological diseases ranked first among all fields, with a total of 22 updates, including 12 for chemical drugs, 9 for biologics, and 1 for cell therapy.On July 28, Roche announced the latest positive data on Trontinemab for the treatment of Alzheimer's disease. Trontinemab is a targeted amyloid monoclonal antibody utilizing Roche's brain shuttle technology. Analysis shows that Trontinemab continues to demonstrate rapid and significant amyloid plaque clearance, with 91% of participants turning negative in amyloid positron emission tomography (PET) assessments, while the incidence of amyloid-related imaging abnormalities associated with edema/effusion (ARIA-E) remains below 5%.On July 31, AbbVie announced that Rinvoq (Upadacitinib) had met the primary endpoint in a pivotal study from the Phase III UP-AA clinical program. Analysis showed that 44.6% and 54.3% of patients with severe alopecia areata (AA) receiving 15mg and 30mg doses, respectively, achieved over 80% scalp hair coverage after 24 weeks of treatment. Additionally, 36.0% and 47.1% of patients treated with 15mg and 30mg Upadacitinib, respectively, reached SALT ≤10 (over 90% scalp hair coverage) at week 24, compared to only 1.4% in the placebo group.Global New Drug Development Progress Details (Partial)
Global Pharmaceutical Transaction EventsThis statistical cycle（2025.07.26-08.01）There were a total of 33 pharmaceutical transaction events globally (including China), involving multiple transactions such as drug rights transfers and company acquisitions.
Summary Table of Global Pharmaceutical Transaction Times (Partial)
Drug Approval/Development Updates in ChinaNew Drug Approvals in ChinaAccording to the PharmaBlock data statistics analysis, the statistical cycle for this period (2025.07.26-08.01)A total of 12 new drugs were approved for marketing by the NMPA in China, including 1 NDA approval, 1 BLA approval, 9 new indication approvals, and 1 new formulation approval. Compared with the previous statistical cycle, this time there are 9 more new drugs approved by the NMPA.
On July 28, Antengene announced that the new indication for Xpovio® (selinexor tablets) has been officially approved by the NMPA for use in combination with bortezomib and dexamethasone (XVd regimen), applicable to adult patients with multiple myeloma (MM) who have received at least one prior line of therapy. Studies have confirmed: The XVd regimen compared to the Vd regimen demonstrates better clinical efficacy in Chinese R/R MM patients, with longer observed PFS and DOR, achieving higher ORR, ≥VGPR rates, and MRD negativity rates, and showing a trend toward OS prolongation. Notably, the subgroup of elderly patients aged ≥65 years showed even more significant efficacy, offering this population an improved treatment option with Xpovio®.On July 31, the NMPA announced that Zotec Pharmaceutical (Guangzhou) Co., Ltd., a wholly-owned subsidiary of Lee's Pharmaceutical Holdings, received official approval for a new indication of its innovative drug SocaZoli monoclonal antibody injection (Shankeyu®): in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. Study results showed a median OS of 13.9 months, extending survival by 2.32 months compared to chemotherapy alone, reducing the risk of death by 20%; the 2-year survival rate was 20.7%, more than three times that of the control group; the risk of disease progression was reduced by 43%, with good safety.New Drug Approvals in China (Partial)Progress of Implied Consent for New Drug Clinical Trials in ChinaAccording to the PharmaBlock data statistics analysis, the statistical cycle for this period (2025.07.26-08.01)) A total of 28 new drugs received clinical tacit approval in China, involving 43 application numbers.Among them, there are 12 chemical drugs, 14 therapeutic biological products, and 2 preventive biological products.Compared with the last statistical period, this time there was a reduction of 11 clinical tacit approval acceptance numbers.
This Week's Progress on Clinical Tacit Permits for New Drugs in China (Partial)
Progress of New Drug Applications in ChinaAccording to the PharmaBlock data analysis, during this statistical period (July 26, 2025 - August 1, 2025), there were a total of 6 new drug applications for marketing in China, involving 12 acceptance numbers. Among them, there were 4 chemical drugs and 2 therapeutic biological products. Compared with the previous statistical period, this period saw an increase of 8 new drug application acceptance numbers.。
New Drug Marketing Applications in ChinaAccording to the data analysis by PharmaDJ, during this statistical period (July 26, 2025 - August 1, 2025), there were 44 new drug clinical trial applications in China, involving 62 application numbers. Among them, 26 were chemical drugs, 17 were therapeutic biologics, and 1 was a preventive biologic. Compared with the previous statistical period, there was a decrease of 17 clinical trial application numbers in this cycle.
Clinical Trial Applications for New Drugs in China (Partial)According to the statistical analysis by PharmaDJ, the current statistical period (2025.07.26-08.01)China Adds 3 New ApprovalsNMPADrugs with special qualification designation. Among them, 3 are chemical drugs. Compared to the last statistical cycle, this round sees an increase of 2 drugs granted special qualification designation by the NMPA.
On July 29, the CDE website announced that the inhalation suspension TQC3721, a Class 1 new drug developed by Zhengda Tianqing, is proposed to be included in the breakthrough therapy category for the maintenance treatment of chronic obstructive pulmonary disease (COPD). TQC3721 is an inhaled PDE3/4 inhibitor with a novel mechanism, possessing both bronchodilatory and anti-inflammatory effects, which alleviate patient symptoms, suppress inflammation, and control disease progression. Clinical research results show that TQC3721 significantly improves lung function and symptom scores in COPD patients under the background treatment of single and dual bronchodilators.On July 30, the CDE website announced that the self-developed Class 1 new drug Rovacitinib tablets (TQ05105) by Zhengda Tianqing is proposed to be included in the breakthrough therapy designation for the treatment of chronic graft-versus-host disease. Allogeneic hematopoietic stem cell transplantation is a key method for treating high-risk hematological malignancies, but subsequent graft-versus-host disease (GVHD) is a major complication and cause of death. Rovacitinib has shown significant potential in clinical research. The latest study results for chronic GVHD indicate that the best overall response rate for all affected organs reached 90.9%, with nearly 90% of patients able to reduce their corticosteroid dosage. In the more challenging treatment of glucocorticoid-resistant acute GVHD, Phase Ib clinical data showed an overall response rate of 84% at 28 days, with a one-year survival rate as high as 92.3%, and it significantly reduced patients' reliance on corticosteroids.NMPAProgress on Special Drug Designation
Progress in New Drug Development in ChinaAccording to the statistical analysis by PharmaDJ, during this statistical period (July 26, 2025 - August 1, 2025), there were a total of 5 updates on the clinical R&D status of new drugs in China, covering four therapeutic areas: oncology, respiratory diseases, endocrine system diseases, and neurological disorders. Among them, there was 1 chemical drug, 3 biologics, and 1 cell therapy. Compared with the previous statistical period, there is one less update on the clinical R&D status of new drugs in China.
On July 28, Shize Bio announced the successful completion of the "world's first" patient dosing in a Phase I registrational clinical study for its iPSC-derived regenerative spinal cord neural cell therapy (XS228 Cell Injection) targeting severe neurological disorders, specifically spinal cord injury. Following transplantation with clinical-grade iPS-derived regenerative spinal cord neural cells, the first subject in the registrational clinical trial experienced no surgical or perioperative complications or other adverse safety events, with all test indicators remaining normal. The subject successfully passed the observation period and has now entered the formal follow-up phase. This China-U.S. dual-filed and dual-approved registrational clinical trial marks an important milestone in the field of global central nervous system injury repair. It serves as a significant benchmark for exploring the safety of regenerative spinal cord neural cell transplantation in treating spinal cord injuries and analyzing its potential impact on patient outcomes.On July 31, Imming Angke announced preliminary safety and efficacy data from the clinical trial in China of IMM2510/AXN-2510, a PD-L1xVEGF bispecific antibody, combined with chemotherapy for first-line treatment of NSCLC. As of July 1, 2025, 33 patients received a dose of 10mg/kg, among which 21 patients had at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy-evaluable patients, including 80% of squamous NSCLC patients and 46% of non-squamous NSCLC patients. No dose-limiting toxicity was observed among the 33 safety-evaluable patients.Progress in New Drug Development in China
Policy and Regulatory Updates in China's New Drug Development FieldNotice of the Center for Drug Evaluation of the National Medical Products Administration on Issuing the "Technical Guideline for Model-Informed Drug Development for Rare Diseases" (No. 25, 2025)To guide sponsors in effectively applying quantitative pharmacology methods during the research and development process of rare disease drugs, as well as scientifically and reasonably designing quantitative pharmacology studies, the Drug Evaluation Center has organized the formulation of the "Technical Guiding Principles for Model-Informed Rare Disease Drug Development" (see attachment).According to the requirements of the "Notice of the General Office of the National Medical Products Administration on Issuing the Procedures for the Release of Drug Technical Guidelines" (Yaojian Zongyao Guan [2020] No. 9), it has been reviewed and approved by the National Medical Products Administration, and is hereby announced, to be implemented from the date of issuance. This is to notify.Hot News in China's New Drug Development FieldZai Lab Reaches Turning PointUnder the explosive market trend, the innovative drug industry has once again entered a phase of jubilation, with Biotech companies frequently seeing several-fold increases in value. In such an atmosphere, Zai Lab appears unusually low-key; its market value of over 30 billion Hong Kong dollars pales in comparison to its previous peak of over a trillion Hong Kong dollars during the last boom. This might be related to the current pharmaceutical bull market being driven by License-out deals. Behind this low profile, however, lies a critical transformative period for Zai Lab. The report card for the first half of the year is about to be released, and while it may still fall slightly short of official profitability, the answer to the debate over business models will soon be revealed amidst the high growth trend.Refinement and TranscendenceIn 2014, Zai Lab was born, with its founder Dr. Samantha Du infusing it with the ambitious spirit of "reaching the pinnacle once again." At that time, China's innovative drug industry was still in its infancy, yet Zai Lab resolutely chose a challenging path—quickly building a late-stage product pipeline through the License-in (authorized introduction) model.More information, read the original textA New Star in Autoimmunity is RisingThe bull market for innovative drugs continues.Since the beginning of this year, as of the closing on July 28, among the 155 companies in the Hong Kong Stock Exchange's Hang Seng Pharmaceuticals and Biotechnology Industry, 54 have achieved a doubling of their stock prices. Among them, Connaught stood out particularly: its stock price climbed from a low of HK$27.05 to HK$63.9, with an increase of over 130%. On July 17 alone, the stock price surged by 26.2%, becoming a focal point for investor attention.The performance of the capital market is often a reflection of corporate value. This Chinese biopharmaceutical company, established in less than a decade, is emerging on the global pharmaceutical stage with a unique commercialization path and innovative overseas expansion model.More information, read the original textLittle D Has Something to Say
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