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Hualan Biological’s application for clinical trial of pembrolizumab injection has been accepted

Hualan BiologicalOn December 16, the company announced at noon that its investee company, Hualan Gene Engineering Co., Ltd., received the “Acceptance Notice” from the National Medical Products Administration for its application for clinical trial registration of pembrolizumab injection for domestic production. Hualan Biological stated that its pembrolizumab injection is a biosimilar. The original pembrolizumab product (trade name: Keytruda®) is manufactured by Merck.The company developed one of the world’s first approved PD-1 inhibitors, which has been approved globally for dozens of important oncology indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer. Its clinical value has been widely recognized. https://finance.eastmoney.com/a/202512163592877572.html
- Source: drugdu
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- December 16, 2025
Another Phase 3 clinical trial failed.

Recently, biotechnology company Arcus Biosciences and its partner Gilead announced the formal termination of the Phase III clinical trial STAR-221 , which combines PD-1, TIGIT, and chemotherapy as first-line treatment for gastric cancer , because the study showed no efficacy in the interim analysis . STAR-221 is a global, randomized, open-label phase III clinical trial that enrolled approximately 1040 patients with locally advanced, unresectable, or metastatic HER-2-negative gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The study aimed to evaluate the efficacy and safety of Arcus’ anti-TIGIT monoclonal antibody domvanalimab in combination with its PD-1 inhibitor zimberelimab and chemotherapy regimens (FOLFOX or CAPOX) as first-line treatment, compared to the standard therapy nivolumab (Opdivo) in combination with chemotherapy. The primary endpoint of the study was to assess overall survival (OS) in tumors with high PD-L1 expression (TAP ≥ 5%), PD-L1-positive tumors (TAP ≥ 1%), and the intention-to-treat population (all PD-L1 levels) ...
- Source: drugdu
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- December 16, 2025
Ascletis Investors surges fourfold! A quiet turnaround for Ascletis!

Recently, Ascletis Pharma released Phase II study data for its oral small molecule GLP-1 drug ASC30. In 125 obese or overweight subjects, the 60 mg dose group experienced a weight loss of up to 7.7%, and no weight loss plateau was observed. Following the announcement, Ascletis Pharma’s stock price surged by more than 20% intraday on December 9. In fact, Ascletis Pharma’s stock price has increased approximately fourfold this year, ranking among the top performers in the pharmaceutical industry. 01 The data is amazing. small molecule GLP-1R completely biased agonist developed by Ascletis Pharma . According to publicly available information from Ascletis Pharma, this drug possesses unique and differentiated properties, and can be taken orally once daily or subcutaneously once monthly to quarterly as a treatment or maintenance therapy for long-term weight management. Furthermore, it is not subject to dietary restrictions and can be taken at any time of day. ...
- Source: drugdu
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- December 16, 2025
Fosun Pharma Receives Regulatory Inquiry Letter from SSE Over Planned Controlling Stake Acquisition of Green Valley Pharmaceutical

On December 16, the Shanghai Stock Exchange (SSE) issued a regulatory inquiry letter to Fosun Pharma regarding its external investment in Green Valley Pharmaceutical, addressing matters related to the listed company. On December 15, Fosun Pharma announced that its controlling subsidiary, Fosun Pharma Industrial, had entered into a relevant investment agreement with Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd. (“Green Valley Pharmaceutical”) and its existing shareholders. The agreement involves an investment of approximately RMB 1.412 billion to acquire a controlling stake in Green Valley Pharmaceutical. Upon completion of the acquisition, Green Valley Pharmaceutical will become a controlling subsidiary of Fosun Pharma, and its core drug, Sodium Oligomannate Capsules, will be integrated into Fosun Pharma’s innovative drug pipeline. The drug is primarily indicated for the treatment of mild to moderate Alzheimer’s disease. Reference: https://finance.eastmoney.com/a/202512163592385827.html
- Source: drugdu
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- December 16, 2025
Innovation-Driven Vaccine Upgrades, Focusing on Core Products and Pipeline Development

After fifteen years of deep cultivation in the vaccine field, AB&B Bio Tech has accelerated on the path of differentiated innovation. Listed on the Hong Kong Stock Exchange in August, AB&B Bio Tech has fortified its competitive edge with core products such as its first quadrivalent subunit influenza vaccine covering all age groups from 6 months and above. Its Hong Kong IPO was oversubscribed by over 4,000 times. In a recent exclusive interview with China Securities Journal, An Youcai, Chairman and General Manager of AB&B Bio Tech, comprehensively detailed the company’s product strategy, performance delivery logic, use of raised funds, and future development blueprint. He clarified that with “innovation-driven” as the core, the company aims to achieve a revenue target of RMB 2 billion by 2030 through capacity expansion and international布局, striving to join the top tier of domestic vaccine enterprises. Differentiated Strategy Enhances Product Competitiveness AB&B Bio Tech listed ...
- Source: drugdu
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- December 16, 2025
Huadong Medicine has made a significant leap in international research and development. Its new product has been granted orphan drug status by the FDA

On December 15th, Huadong Medicinel (000963) announced that its independently developed ADC innovative drug, Injection HDM2012, has obtained orphan drug qualification recognition (Orphan Drug Designation, ODD) from the US Food and Drug Administration (referred to as “US FDA”) for two indications: gastric cancer and gastroesophageal junction cancer, as well as pancreatic cancer. This proves that the innovative nature of its ADC research has been internationally recognized. Meanwhile, the innovative multi-peptide-based long-acting agonist HDM1005 injection for dual-targeting human GLP-1 (glucagon-like peptide-1) receptor and GIP receptor (glucose-dependent insulinotropic polypeptide), developed by the wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmei Huadong”), achieved positive results in the Phase II clinical trial for weight management indications in China. These two milestones signify a significant leap forward for Huadong Pharmaceutical in the internationalization and cutting-edge exploration of new drug research. They not only demonstrate the company’s successful implementation of its ...
- Source: drugdu
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- December 16, 2025
Rona Therapeutics Completes First Cohort Dosing in First-in-Human Phase 1 Clinical Trial of Obesity Treatment RN3161

Rona Therapeutics announced on December 15, 2025, that Cohort 1 dosing for their RN3161 drug, a GalNAc-conjugated siRNA targeting INHBE for obesity, had been completed in its Phase 1 clinical trial. Initial data from this cohort indicated good safety and tolerability, reaching a clinical milestone for the company’s INHBE program. Completion of dosing for the remaining cohorts is expected in 2026. https://finance.eastmoney.com/a/202512153592095373.html
- Source: drugdu
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- December 16, 2025
The World Health Expo Miami

Organiser：Informa Group Time： June 17 – 19, 2026 Address：1901 Convention Center Drive, Miami Beach, USA Exhibition hall：Miami Beach Convention Center Product range: Medical Equipment: Laboratory supplies, operating room equipment, medical consumables, orthopedic products, medical imaging equipment, ophthalmic equipment, therapeutic instruments and accessories, biochemical and laboratory testing equipment, testing, analysis, and diagnostic instruments and accessories, electronic medical instruments, medical furniture Rehabilitation and Nursing: Assistive devices for the disabled, rehabilitation and nursing instruments, monitoring instruments, orthopedic equipment, dental equipment, cleaning, disinfection, and sterilization products, medical packaging, home care products, knitted and cotton fabrics, pharmaceuticals and nutritional health products, disposable products, etc. About The World Health Expo Miami： The World Health Expo Miami is the largest medical professional exhibition in the southeastern region of the United States. In addition to attracting exhibitors and professional buyers primarily from Florida, it also draws a significant number of exhibitors and professional buyers from Latin ...
- Source: drugdu
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- December 16, 2025
Juncell Bio plans to list in Hong Kong.

On December 10, Shanghai Junsai Biotechnology Co., Ltd. (hereinafter referred to as “Junsai Biotechnology”) submitted a listing application to the Hong Kong Stock Exchange. According to its prospectus, Junsai Bio is a biotechnology company dedicated to the development of innovative cell therapies and drugs for solid tumors. Its core product, GC101, is expected to become the first approved tumor-infiltrating lymphocyte (TIL) therapy. In 2023, 2024, and the first half of 2025, the company projected net losses of RMB 94 million, RMB 164 million, and RMB 98 million, respectively. The core product GC101 undergoes important testing. According to its prospectus, Junsai Bio focuses on the huge unmet clinical needs in the treatment of solid tumors and is developing the next generation of pan-solid tumor immunotherapy. According to the company, its core product GC101 is currently undergoing a pivotal Phase II clinical trial for the treatment of melanoma, with a Biologics License ...
- Source: drugdu
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- December 15, 2025
Plans to acquire the “Multiple Trace Element Injection Assets” of Tibet Future and its two wholly-owned subsidiaries

On December 14, Zhejiang Zouli Pharmaceutical Co., Ltd. issued an announcement stating that its board of directors had approved the “Proposal on Purchasing an Asset Group and Signing an Acquisition Agreement.” The company plans to acquire a group of trace element injections held by Tibet Future Biomedical Co., Ltd. and its two wholly-owned subsidiaries for a total price (including tax) of RMB 356 million. This asset group covers core assets such as R&D and production technology data, marketing authorizations, trademarks, and patents related to the marketed “Multiple Trace Element Injection (I)” and “Multiple Trace Element Injection (II),” as well as the research and development “Multiple Trace Element Injection (III)” under development. The announcement indicates that multi-trace element injections are a major source of trace elements in parenteral nutrition, especially suitable for nutritional supplementation in special populations such as children and critically ill patients. Among them, multi-trace element injection (I) and ...
- Source: drugdu
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- December 15, 2025

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