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[China Resources Shuanghe: DC7001A capsules have been approved for clinical trials by the U.S. FDA] On October 11, China Resources Shuanghe (600062.SH) announced that the company’s wholly-owned subsidiary Beijing Shuanghe Runchuang Technology received a notice from the U.S. FDA agreeing to conduct clinical trials of DC7001A capsules. The drug is intended to be used to treat systemic lupus erythematosus and has been approved for drug clinical trials by the State Food and Drug Administration.
#clinical trial#A-share announcement express10-11 15:42
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[Mengke Pharmaceutical: Signed an exclusive license agreement and platform cooperation agreement for MRX-23 with ClearideBio, with a total payment limit of US$750 million] On October 9, Mengke Pharmaceutical (688373.SH) announced that the company plans to sign an exclusive license agreement and platform technology cooperation agreement for the MRX-23 project with ClearideBio of Switzerland. The former involves the global exclusive license of the MRX-23 project; the latter is a multi-project option cooperation based on the company's independently developed new camptothecin-loaded "STOPIN" antibody-conjugated drug platform. ClearideBio can exercise the option for an agreed number of targets or target combination projects as agreed in the agreement. According to the MRX-23 license agreement, an initial payment of US$1 million will be paid as agreed after the agreement comes into effect. This amount is non-refundable after payment; recent development milestone payments are triggered when the licensed product obtains approval of the clinical trial application for the first time. The total nominal maximum payment limit for MRX-23 R&D, registration and sales milestones is US$223 million, and the total maximum payment limit when all platform cooperation projects are exercised and all milestones are achieved is US$750 million.
#clinical trial#EA#A-share announcement express10-09 19:02
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[Zhongsheng Pharmaceutical: Phase III clinical trial of the first-class innovative drug RAY1225 for weight loss reaches the primary endpoint] On October 8, Zhongsheng Pharmaceutical (002317.SZ) announced that the phase III clinical trial (REBUILDING-2) of the first-class innovative peptide drug RAY1225 injection independently developed by its holding subsidiary Zhongsheng Ruichuang in overweight or obese participants has obtained top-line analysis data and reached the primary endpoint. The results showed that the body weight of the RAY1225 injection 9 mg group was reduced by 22.24% compared with the baseline, and by 20.46% after placebo correction. The weight loss target rate and the improvement of cardiovascular and metabolic indicators were significantly better than the placebo, and the safety was good. The company reminds that the complete results are subject to the final clinical summary report, and there is uncertainty in the drug launch.
#clinical trial#A-share announcement express10-08 18:09
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[The concept of innovative drugs fluctuated and fell, and Alex dropped by 20cm.] On October 8, the concept of innovative drugs fluctuated and fell by 20cm, with Ellis falling by the limit of 20cm, Bepsis falling by more than 10%, and Yahong Pharmaceutical, Maiwei Biotech, Technomax, Huiyu Pharmaceutical, Rejing Biotech, etc. followed suit. On the news, Arris announced that the phase III clinical trial of fumetinib did not meet the primary study endpoint. Affected by this news, partner ArriVent's US stock price plummeted 47% in a single day on October 6.
#clinical trial#Live broadcast#Innovative drugs#hot landscape creature10-08 09:41
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[Alice: The phase III clinical trial of fumetinib did not meet the primary study endpoint] On October 7, Ellis (688578.SH) announced that the company's product fumetinib mesylate tablets ("vometinib") monotherapy is FURVENT for the treatment of previously untreated patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) carrying EGFR exon 20 insertion mutations. The Phase III trial did not meet its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR). Clinical benefit was observed on secondary endpoints such as investigator-assessed PFS and BICR-assessed confirmed objective response rate (ORR); although overall survival (OS) data are not yet mature, a clear trend of improvement has been observed. The safety profile observed in the FURVENT trial was consistent with previous clinical studies of fumetinib, and no new safety signals were found. Together with ArriVent, the company is evaluating FURVENT's complete data set to determine next steps. As of September 30, 2026, the company has invested a total of approximately 70.82 million yuan in key clinical trials of fumetinib for first-line treatment of exon 20 insertion mutations. The above-mentioned research and development expenses have been included in the profits and losses of the corresponding accounting period when they are incurred, and will not have a significant impact on the company's current performance.
#clinical trial#cell#A-share announcement express10-07 16:28
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[Betta Pharmaceuticals: BPI-572270 capsules have been approved by the U.S. FDA for clinical trials of new drugs] On October 7, Betta Pharmaceuticals (300558.SZ) announced that the clinical trial application for BPI-572270 capsules submitted by the company's wholly-owned subsidiary Jingyao Biotech was approved by the U.S. FDA and is intended to be used for advanced solid tumors. The drug is a self-developed pan-RAS "non-degradable molecular glue" inhibitor. Preclinical studies have shown that it has a strong inhibitory effect on a variety of RAS mutated tumor cells. The company reminds that the research and development cycle of new drugs is long, the investment is large, and the results of clinical trials and approvals are uncertain, which will not have a significant impact on recent performance.
#clinical trial#molecular#cell#A-share announcement express10-07 16:16
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[Zhongsheng Pharmaceutical: ZSP1601 tablets are included in the breakthrough therapy drug program] On October 7, Zhongsheng Pharmaceutical (002317.SZ) announced that ZSP1601 tablets, a class of innovative drug independently developed by the company’s holding subsidiary Zhongsheng Ruichuang, was included in the breakthrough therapy drug program by the Drug Evaluation Center of the State Food and Drug Administration, and the proposed indication is metabolism-associated steatohepatitis (MASH). ZSP1601 tablets are a first-in-class innovative drug (First-in-Class) for the treatment of MASH with global independent intellectual property rights and a new mechanism of action. It is a major national new drug creation project. The phase IIb clinical trial of ZSP1601 tablets for the treatment of MASH has obtained positive data results, and the primary efficacy endpoint of pathological improvement was achieved after 48 weeks of treatment. At the same time, it achieves the triple benefits of anti-fibrosis, reducing liver fat content, and improving liver enzymes, with fast onset, robust effect, and excellent safety.
#clinical trial#A-share announcement express10-07 15:49
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On October 6th, U.S. stock Vaxcyte is now up 27%, having risen nearly 60% earlier. It was reported that the company’s pneumococcal vaccine has reached late-stage clinical trial targets.
#clinical trial#vaccine#Global market intelligence#U.S. stock trends10-06 02:59
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[The three major U.S. stock indexes opened mixed, Vaxcyte rose more than 54%] On October 5, the three major U.S. stock indexes opened mixed, with the Dow Jones falling 0.14%, the S&P 500 rising 0.08%, and the Nasdaq Composite rising 0.15%. Vaxcyte rose more than 54% after the company's pneumococcal vaccine met late-stage clinical trial goals. Critical Metals rose more than 8% after the company received Greenland's approval for its Tanbreez project mining and closure plan. Vistra Energy rose more than 3% as the United States will provide it with a $4 billion loan to increase nuclear power generation. Cryptocurrency concept stocks generally rose, with Circle, Coinbase, and Strategy rising by more than 2%.
#Coinbase#Meta#clinical trial#vaccine#Global market intelligence#U.S. stock trends10-05 21:30
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[Vaxcyte U.S. stocks surged over 85% before the market opened] On October 5, the U.S. stock price of Vaxcyte surged over 85% before the market opened, after the company’s pneumococcal vaccine reached late-stage clinical trial targets.
#clinical trial#vaccine#Global market intelligence#U.S. stock trends10-05 18:35
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[Vaxcyte U.S. stocks surged over 61% before the market opened] On October 5, the U.S. stock price of Vaxcyte surged over 61% before the market opened, after the company’s pneumococcal vaccine reached late-stage clinical trial targets.
#clinical trial#vaccine#Global market intelligence#U.S. stock trends10-05 18:26
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[Vaxcyte U.S. stocks surged more than 25% before the market opened] On October 5, the U.S. stock price of Vaxcyte surged more than 25% before the market opened, after the company’s pneumococcal vaccine reached late-stage clinical trial targets.
#clinical trial#vaccine#Global market intelligence#U.S. stock trends10-05 18:13
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On September 30th, AbbVie announced that its drug under development, ABBV-295, showed a weight loss effect of up to 9.8% in a phase 1 clinical trial, showing "meaningful weight loss."
#clinical trial#weight loss pills09-30 17:52
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[Balitianheng: The first subject has been enrolled in the T-Bren phase III clinical trial] On September 29, Baileytianheng (688506.SH) announced that the company's independently developed injectable T-Bren (HER2ADC) has completed the first subject enrollment in the phase III randomized controlled clinical trial comparing BL-M07D1 with physician-selected chemotherapy in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. As of now, T-Bren is conducting 20 clinical trials at home and abroad, and two of its indications have been included in the list of breakthrough therapies by the Drug Evaluation Center of the State Food and Drug Administration.
#clinical trial#A-share announcement express09-29 18:54
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[Lepu Medical: Subsidiary MWN110 injection has been approved for clinical trials by the U.S. FDA] On September 28, Lepu Medical (300003.SZ) announced that the company’s controlled subsidiary Shanghai Minwei Biotech has received a notice from the U.S. FDA agreeing to conduct clinical trials of MWN110 injection. The drug is a monoclonal antibody targeting ActRIIA/B. The applied indication is overweight or obesity. It has global intellectual property rights and has been approved by CDE for clinical trials in July 2026. Non-clinical studies have shown that the drug alone can significantly reduce body fat percentage, weight and increase muscle mass, while combined use with semaglutide can inhibit muscle loss. At present, no similar drugs have been approved for marketing at home or abroad.
#clinical trial#clone#A-share announcement express09-28 18:39
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[Hisco: Innovative drug HSK42360-Na tablets are included in the Breakthrough Therapy Drug Program] On September 27, Hisco (002653.SZ) announced that the company's innovative drug HSK42360-Na tablets were officially included in the "Breakthrough Therapy List" by the Drug Evaluation Center of the State Food and Drug Administration for the treatment of recurrent or progressive high-grade gliomas with BRAFV600 mutations. The drug is a BRAF paradoxicalbreaker inhibitor independently developed by the company. It has excellent central nervous system penetration. Clinical trials that have been carried out have shown outstanding efficacy and controllable safety. After being included as a breakthrough therapy, it is expected to obtain priority review qualifications during the marketing application stage and accelerate the marketing process.
#clinical trial#Cisco#EA#A-share announcement express09-27 15:51
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[Chengda Biotech: Signed Recombinant Tetravalent Enterovirus Vaccine Technology Transfer Contract] On September 24, Chengda Biotech (688739.SH) announced that the company signed a "Recombinant Quadrivalent Enterovirus Vaccine Technology Transfer Contract" with Wiltek, and transferred all rights and interests of the recombinant quadrivalent enterovirus vaccine (Hansenula yeast) project. The technology transfer fee is 46 million yuan (tax included), which will be paid in installments based on milestones; sales commissions and sales milestone rewards will be paid based on the sales of the product after it is launched. The subject product is still in the early stages of research and development, and there are uncertainties in subsequent clinical trials, registration approval and commercialization.
#clinical trial#Virus#vaccine#A-share announcement express09-24 17:20
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[Four-connected Nanhua Bio: Cell therapy-related technologies and products are still in the research and development stage, and no innovative drugs have been launched or entered the clinical trial stage] On September 22, Nanhua Bio (000504.SZ) issued a stock trading risk warning announcement stating that the company's current main business is biomedicine and energy conservation and environmental protection. Among them, the biomedicine segment mainly provides customers with testing and storage services for biological resources such as stem cells and immune cells. It also cooperates with a number of clinical research institutions to provide them with cell preparation, testing and other services that meet clinical research requirements. The company's cell therapy-related technologies and products are still in the research and development stage, and no innovative drugs have been launched or entered the clinical trial stage. The energy-saving and environmental protection segment is mainly engaged in lithium carbonate business, scrap steel renewable resources and supporting processing and sales.
#clinical trial#stem cells#cell#A-share announcement express#A-share risk warning announcement09-22 18:20
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[Yahong Pharmaceutical: APL-2501 has completed the enrollment of the first subject in the Phase I clinical trial] On September 22, Yahong Pharmaceutical (688176.SH) announced that the company's independently developed APL-2501 has completed the enrollment of the first subject in the Phase I/II clinical trial in patients with advanced solid tumors. The drug is an anti-CLDN6/9 antibody-drug conjugate independently developed by the company based on a topoisomerase inhibitor. It can be used to treat a variety of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, endometrial cancer, and gastric cancer. The research has been approved by the US FDA and the State Food and Drug Administration, and this matter will not have a significant impact on the company's recent performance.
#clinical trial#cell#A-share announcement express09-22 17:43
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On September 22, Roche’s ENICEPATIDE met the two primary endpoints of its Phase II clinical trial.
#clinical trial09-22 13:07
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[AI pharmaceutical company Iambic backed by NVIDIA submits U.S. IPO application] "Science and Technology Innovation Board Daily" reported on the 22nd that Iambic Therapeutics, an AI pharmaceutical company backed by NVIDIA and Qatar's sovereign wealth fund, submitted a U.S. initial public offering (IPO) application on Monday local time. Founded in 2019 (formerly known as Entos), Iambic is currently advancing a pipeline of drug candidates developed using its AI platform to treat solid tumors. Its most advanced drug candidate, IAM1363, is in early-stage clinical trials for the treatment of solid tumors such as breast cancer.
#clinical trial#NVIDIA#AI09-22 08:39
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[Shenlian Bio: The Phase II clinical trial of UB-221 for the treatment of chronic spontaneous urticaria has reached the primary endpoint] On September 20, Shenlian Biotech (688098.SH) announced that the Phase II clinical study of UB-221 injection, a Class 1 biologic drug independently developed by Shizhiyuan, a subsidiary of the company controlled by the company, for the treatment of chronic spontaneous urticaria has reached the primary endpoint and achieved positive top-line results. A total of 145 subjects were included in the study. The HSS7=0 response rates at week 12 in each dose group of UB-221 were 54%, 53% and 43% respectively, which were significantly higher than the 11% in the placebo group. In terms of safety, UB-221 was generally well tolerated, and no serious adverse events related to treatment occurred. The above-mentioned matters are not expected to have a significant impact on the company's performance in the short term, and subsequent procedures such as phase III clinical research and new drug marketing applications need to be completed.
#clinical trial#A-share announcement express09-20 15:32
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[State Food and Drug Administration: Establishing a market exclusivity period system for children’s drugs, rare disease drugs and other fields to make corporate R&D investments more secure] On September 20, Yang Sheng, deputy director of the State Food and Drug Administration, said at a press conference of the State Council Information Office that the implementation of the drug experimental data protection system will be promoted and a market exclusivity period system for children’s drugs, rare disease drugs and other fields will be established to make corporate R&D investments more secure. Improve the communication and exchange mechanism for early R&D, and strengthen pre-guidance for innovative drugs with new targets and new mechanisms, so that enterprises can avoid detours in R&D. Expand medical devices, transform clinical innovation results into Spring Rain Action, and formulate clinical trial and review guiding principles in cutting-edge fields such as brain-computer interfaces to pave the way for future industries.
#clinical trial#brain computer interface#Rare disease#interface09-20 10:54
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[Lifang Pharmaceuticals: Celecoxib Tramadol Hydrochloride Tablets Clinical Trial Application Accepted] On September 18, Cubic Pharmaceuticals (003020.SZ) announced that the company received the "Acceptance Notice" for the drug registration clinical trial application of Celecoxib Tramadol Hydrochloride Tablets issued by the State Food and Drug Administration. The proposed indication is the treatment of short-term moderate to severe acute somatic pain in adults. The original research drug of this product will be approved for marketing in the United States in 2021, but has not yet been launched in China. The company is the first domestic enterprise to apply for clinical trials.
#clinical trial#A-share announcement express09-18 15:51
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[Laser targeting technology is used to eliminate localized pancreatic tumors for the first time] On September 17, UCI Health, the academic medical system of the University of California, Irvine, launched a Phase I human clinical trial, using laser targeting technology to treat localized pancreatic tumors for the first time to help patients get rid of pancreatic cancer. The relevant paper was published in the latest issue of the Journal of Vascular and Interventional Radiology.
#clinical trial#EA#Global market intelligence09-17 07:01
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[Shanghai RAAS: SR604 Injection Enters Phase III Clinical Trial] On September 16, Shanghai RAAS (002252.SZ) announced that the company’s product under development, “SR604 Injection,” recently announced the registration information for the Phase III clinical trial of “Preventive Treatment of Bleeding Episodes in Hemophilia A/B Patients” on the Drug Clinical Trial Registration and Information Disclosure Platform of the State Food and Drug Administration. SR604 injection is a humanized monoclonal antibody preparation that binds to human activated protein C with high affinity and specifically inhibits the anticoagulant function of human activated protein C. The company is conducting a phase III confirmatory clinical study on the indications for the prevention and treatment of bleeding episodes in patients with hemophilia A/B. It plans to conduct a multiple-dose trial of 0.4 mg/kg once every 4 weeks. If this variety is successfully developed, it is expected to significantly improve the medication experience of hemophilia A/B patients. As of the disclosure date of this announcement, there is no product with the same target as this drug on the market globally.
#clinical trial#clone#A-share announcement express09-16 19:54
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[Hengrui Pharmaceuticals: Subsidiary's raciximab for injection has been approved for clinical trials] On September 15th, Hengrui Pharmaceuticals (600276.SH) announced that the company's subsidiary Guangdong Hengrui Pharmaceutical has received the approval from the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" for raciximab for injection, and agreed to conduct a Phase III clinical trial for adult patients with intracranial atherosclerotic stenosis to reduce the risk of recurrence of stroke. The drug is an anti-PCSK9 monoclonal antibody independently developed by the company. It has been approved for marketing in China in 2025. The cumulative investment in research and development of related projects is approximately 422 million yuan.
#clinical trial#clone#A-share announcement express09-15 16:35
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[CSPC Innovation: SYS6010 included in the list of breakthrough therapies] On September 15th, CSPC Innovation (300765.SZ) announced that SYS6010, developed by the company's holding subsidiary Jushi Biologics, was included in the list of breakthrough therapies by the Drug Evaluation Center of the State Food and Drug Administration. The proposed indication is recurrent or metastatic driver gene-negative non-squamous non-small cell lung cancer that has failed immune and platinum-containing chemotherapy. SYS6010 is an antibody conjugate drug targeting EGFR, and its Phase III clinical trials are currently underway. The drug has previously received three breakthrough therapy designations.
#clinical trial#Gene#cell#A-share announcement express09-15 16:32
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[Xingqi Eye Medicine: SQ-25012 injection received clinical trial approval notice] On September 15th, Xingqi Eye Medicine (300573.SZ) announced that the company received the "Drug Clinical Trial Approval Notice" for SQ-25012 injection issued by the State Food and Drug Administration and agreed to conduct clinical trials for the treatment of thyroid eye disease. This drug is a recombinant humanized IgG1 type trispecific antibody and is a Category 1 innovative drug for therapeutic biological products. The company has completed pharmaceutical and non-clinical pharmacology and toxicology studies, and the results show that it has good safety and clinical development value. As of the date of the announcement, no drugs of the same type have been approved for marketing.
#clinical trial#A-share announcement express09-15 15:50
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[GSK once again acquires a drug from EnmuBio for up to US$750 million] On September 15, GlaxoSmithKline agreed to purchase an experimental blood cancer drug from a Chinese biotechnology company for up to US$750 million to continue to enrich its expanding oncology pipeline. The British drugmaker said in a statement on Tuesday that it will test the drug it bought from privately held Enmu Biologics as a treatment for multiple myeloma and launch early-stage clinical trials next year.
#clinical trial#Biotechnology#medicine#Pharmaceutical business09-15 15:26