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Phase II Clinical Trial Approved for 9MW3811 Injection in Pathological Scarring

On November 10, Maiwei Biotechnology (688062) issued an announcement stating that the company recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, which approved the application for Phase II clinical trial of 9MW3811 injection for the indication of pathological scars. The clinical trial notification number for this drug is 2025LP02967. The approval conclusion shows that it meets the relevant requirements for drug registration and allows clinical trials to be conducted. 9MW3811 is a humanized monoclonal antibody targeting human IL-11 independently developed by the company. It has high target affinity and signal blocking ability and is expected to demonstrate efficacy in various diseases such as pathological scars and pulmonary fibrosis. The company plans to launch its Phase II clinical trial for pathological scars by the end of 2025 and has entered into an exclusive licensing agreement with CALICO LIFE SCIENCES LLC. CALICO has already paid ...
- Source: drugdu
- 30
- November 11, 2025
Gan & Lee Pharmaceuticals and Hillhouse Capital have reached a strategic cooperation agreement to optimize resource allocation and explore cooperation opportunities.

Shanghai Securities News China Securities(Reporter Zhang Xue) On November 10, Gan & Lee Pharmaceuticals…The company announced the transfer of its controlling stake in its wholly-owned subsidiary, GanGan Medical Technology Jiangsu Co., Ltd. (hereinafter referred to as “GanGan Jiangsu”), to Hillhouse Capital. Founded in 2017, GanGan Jiangsu is an innovation-driven medical technology company specializing in the research and development and production of high-quality drug delivery devices. Leveraging its strong pharmaceutical background and rigorous quality system, the company has established a comprehensive quality management and regulatory compliance system that meets international standards. Its products have obtained certifications from the U.S. Food and Drug Administration (FDA) and the European Union’s CE MDR (European Union Medical Device Registration System).(Regulations) certification. As the transferee, Hillhouse Capital has long focused on investments in the healthcare sector, possessing comprehensive industry chain insights and resource integration capabilities. Leveraging Hillhouse’s extensive experience in healthcare industry operations and value enhancement, ...
- Source: drugdu
- 30
- November 11, 2025
Sinovac Biotech’s GB12 project has been included in Shenzhen’s strategic emerging industries support plan.

Shanghai Securities News China Securities(Reporter Zhao Binbin) On November 10, this reporter learned from Sinovac Biotech…It has been learned that the innovative drug developed by the company’s wholly-owned subsidiary, Shenzhen Sinovac Biotech Co., Ltd.The GB12 project, “Key Technology Breakthrough for AI-Generated IL-4R/IL-31 Bispecific Antibody Innovative Drugs ,” has been included in the list of projects proposed for funding under the first batch of strategic emerging industries support plans of the Shenzhen Development and Reform Commission in 2025. This project aims to develop a bispecific antibody drug for atopic dermatitis (AD). The drug targets both the IL-4R and IL-31 pathways, targeting both inflammation and itching simultaneously. The project plans to submit new drug clinical trial applications in both China and the United States in the future. https://finance.eastmoney.com/a/202511103560094614.html
- Source: drugdu
- 25
- November 11, 2025
CanSino Biologics and Panru Biotech sign licensing agreement to expand the application prospects of the three-component LNP delivery system

Shanghai Securities News China Securities(News from Nian Yue, reporter Zhang Xue) On the 10th, this reporter learned from CanSino Biologics…It has been learned that CanSino Biologics (Shanghai) Co., Ltd., a subsidiary of the company, recently signed a licensing agreement with Panru Biotechnology (Tianjin) Co., Ltd. (“Panru Biotechnology”), licensing its independently developed novel three-component lipid nanoparticle delivery system (ISL-3C-LNP) to Panru Biotechnology to expand its application prospects. CanSino stated that this licensing cooperation marks another important milestone for the company in the field of mRNA delivery technology, and will bring in more than 100 million yuan in revenue in the future, including upfront payments and milestone payments. 　　According to the agreement, Panru Biotech, upon obtaining authorization, can use ISL-3C-LNP as the core LNP lipid for the global research, development, production, and commercialization of its therapeutic prostate cancer mRNA vaccine (PRBT001 injection). It is understood that PRBT001 injection possesses completely independent intellectual ...
- Source: drugdu
- 26
- November 11, 2025
Influenza vaccine components are updated annually to match seasonal epidemic strains

At present, the vaccine compatibility of the H3N2 subtype influenza virus has further improved compared to previous years, and the compatibility of the H1N1 and B influenza viruses is even higher. ”On November 10th, at a press conference held by the National Bureau of Disease Control and Prevention, Wang Dayan, a researcher at the Institute of Viral Disease Control and Prevention of the Chinese Center for Disease Control and Prevention, answered a question from a Science and Technology Daily reporter about the preventive effect of influenza vaccines, stating that the proportion of epidemic strains with antigenicity similar to vaccine strains exceeded 95%. In response to the misconception among a small portion of the public that the flu virus is constantly mutating and cannot be prevented even with vaccination, Wang Dayan made it clear that although the flu virus is prone to mutation, the flu vaccine will be updated annually to ...
- Source: drugdu
- 31
- November 11, 2025
EXPO SALUD 2025

Organiser：FISA S.A. Exhibition Company, Santiago, Chile Time：December 1st – December 3rd, 2025 Address：111 West Harbor Drive, San Diego, CA 92101 Exhibition hall：SAN DIEGO CONVENTION CENTER Product range: Medical Devices and Instrumentation: Medical electronic instruments, Medical ultrasonic instruments, Medical X-ray equipment, Medical optical instruments, Clinical laboratory analysis instruments, Dental equipment and materials, Operating room, emergency room, and consultation room equipment and apparatus, Disposable medical supplies, Medical dressings and hygiene materials, Various surgical instruments, Medical health care equipment and supplies, Traditional Chinese medical instruments and rehabilitation equipment, Hemodialysis equipment, Anesthesia and respiratory equipment. Medical Consumables: Operating room, emergency room, and consultation room apparatus, Operating room clothing, shoes, and gloves, Various medical surgical knives, forceps, scissors, Dental and bone grinding and drilling tools, Microscopes, instrumentation, small electronic instruments, Disposable items and consumables, Cotton textiles, Disposable syringes, blood transfusion sets, Band-aids, masks, bandages, stethoscopes, Toolkits, work uniforms, medical carry cases, gloves, syringes, blood ...
- Source: drugdu
- 29
- November 11, 2025
Preclinical evidence supports sotagliflozin’s superior efficacy in attenuating salt-induced kidney damage

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, initially developed to treat type 2 diabetes, have significant heart- and kidney- protective effects. In the kidney, SGLT2 reabsorbs approximately 97% offiltered glucose in the S1 and S2 segments of the proximal tubule, while SGLT1reabsorbs the remainder in the S3 segment. In research conducted in rats, investigators found that dual inhibition of SGLT1 and SGLT2 more effectively reduces salt-sensitive hypertension and kidney injury than SGLT2 inhibition alone. The findings will be presented at ASN Kidney Week 2025 November 5–9. Salt-sensitive hypertension-elevated blood pressure due to excess salt consumption- affects nearly half of individuals with high blood pressure and substantially contributes to kidney disease, cardiovascular complications, and progression to kidney failure. When researchers compared selective SGLT2 inhibition (through treatment with dapagliflozin) with dual SGLT1/2 inhibition(through treatment with sotagliflozin) in a well-established rat model of salt-induced hypertension and chronic kidney disease, they found that both drugs had ...
- Source: drugdu
- 38
- November 10, 2025
Infant Botulism in 10 US States Linked to Formula Being Recalled

Federal and state health officials are investigating 13 cases in 10 U.S. states of infant botulism linked to baby formula that is being recalled Federal and state health officials are investigating 13 cases in 10 states of infant botulism linked to baby formula that was being recalled, authorities said Saturday. ByHeart Inc. agreed to begin recalling two lots of the company’s Whole Nutrition Infant Formula, the Food and Drug Administration said in a statement. All 13 infants were hospitalized after consuming formula from two lots: 206VABP/251261P2 and 206VABP/251131P2. The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. No deaths were reported. The FDA said it was investigating how the contamination happened and whether it affected any other products. Available online and through major retailers, the product accounted for an estimated 1% of national formula sales, according to the Centers for Disease Control ...
- Source: drugdu
- 34
- November 10, 2025
【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: To apply for a Medical Device Manufacturing License, enterprises need to follow a systematic process that covers material preparation, review stages, and key compliance points, as outlined below: Pre-Application Core Condition Self-Check Qualification Foundations Medical Device Registration: Possession of a valid Medical Device Registration Certificate and product technical requirement documents for the intended medical device production. Business License Scope: The business license must explicitly include medical device manufacturing within its scope of operations. Production Conditions Facilities: Adequate production facilities matching the scale of operations, including cleanrooms (compliant with ISO 14644 standards for sterile medical devices) and storage areas. Provide property ownership certificates or lease agreements. Equipment: Equipped with primary production equipment (e.g., injection molding machines, sterilization equipment) and inspection instruments (e.g., microbiological testers, mechanical testers). A detailed equipment list should be provided. Personnel: Production, quality, and technical leaders must possess relevant professional qualifications (e.g., degrees in biomedical ...
- Source: drugdu
- 32
- November 10, 2025
Innovative Autoimmune Drug to Make its International Academic Debut at CS2015

　China Securities Intelligent Finance News: CStone Pharmaceuticals-B (02616) announced on the morning of November 7th that it will present its pipeline drug CS2015 (OX40L/TSLP bispecific antibody) in the field of autoimmune and inflammation for the first time at the 2025 American Academy of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting through electronic posters and oral presentations. This will be the drug’s first appearance at an international academic conference. 　　According to the announcement, CS2015 employs an asymmetric molecular structure, simultaneously targeting two key inflammatory regulators, OX40L and TSLP, and utilizes a mutant Fc to prolong its circulating half-life, supporting long-term dosing intervals. Preclinical studies have shown that this molecule can potently inhibit inflammatory signaling pathways, exhibiting rapid reduction in skin lesions, decreased immune cell infiltration, and relief of itching in animal models of atopic dermatitis. 　　The announcement indicates that, in terms of drug metabolism, CS2015 exhibits excellent pharmacokinetic characteristics in ...
- Source: drugdu
- 74
- November 8, 2025

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