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Received Clinical Trial Approval for a New Indication of Innovative Drug HSK44459 Tablets

Haisco announced on December 30 that the company has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA). The notice approves the commencement of clinical trials for HSK44459 tablets for the treatment of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease). This drug was independently developed by the company with independent intellectual property rights. Pre-clinical studies indicate that it has a clear target, definite efficacy, and good safety, making it a promising effective treatment for inflammatory bowel disease. However, it should be noted that the research and development of innovative drugs involves long cycles, numerous stages, and high risks, and is subject to uncertainties. https://finance.eastmoney.com/a/202512303605708953.html
- Source: drugdu
- 74
- December 31, 2025
【EXPERT Q&A】What Do Class I, II, and III Medical Devices Specifically Refer to in the Classification of Medical Devices? What Are the Classification Bases?

Drugdu.com expert’s response: I. Specific Definitions of Class I, II, and III Medical Devices Class I Medical Devices Definition: Medical devices with a low degree of risk, whose safety and effectiveness can be guaranteed through routine management. Typical Products: Surgical knives, medical fever-reducing patches, stethoscopes, tongue depressors, medical magnifying glasses, surgical gowns, examination gloves, etc. Management Requirements: Subject to filing management. Production filing is the responsibility of municipal drug regulatory authorities, and no permit is required for operation. Class II Medical Devices Definition: Medical devices with a moderate degree of risk, requiring strict control and management to ensure their safety and effectiveness. Typical Products: Thermometers, blood pressure monitors, blood glucose meters, medical masks, electrocardiographs, B-ultrasound machines, condoms, etc. Management Requirements: Subject to provincial registration. Production requires a “Medical Device Production License,” and operation requires a “Medical Device Business License.” Class III Medical Devices Definition: Medical devices with a relatively high ...
- Source: drugdu
- 85
- December 31, 2025
Huihe Medical Completes Hundreds of Millions-yuan Series D Financing Round with China Taiping Healthcare Fund as Lead Investor, Fueling Chinese Indigenous Medical Devices for Global Expansion

Recently, Shanghai Huihe Medical Technology Co., Ltd. (hereinafter referred to as Huihe Medical) announced the completion of its Series D financing round. This round was strategically led by China Taiping Healthcare Fund, with follow-on investment from its existing shareholder Sherpa Healthcare Fund II (Suzhou) Equity Investment Partnership (Limited Partnership) (hereinafter referred to as Sherpa). This marks another important milestone for Huihe Medical following the closing of its Series C+ financing in 2022, and attests to the capital market’s high recognition of the company’s innovative strength in the field of interventional therapy for structural heart disease. Picture：From VB100 In recent years, insurance capital has emerged as a vital driving force for the development of the healthcare industry. As a quintessential representative of patient capital, insurance capital boasts distinctive strengths in long-term sustainability, stability and cross-cycle asset allocation, which are highly aligned with the healthcare industry’s inherent traits of long investment cycles ...
- Source: drugdu
- 88
- December 30, 2025
FDA Approved! Novel Anti-Cancer Bispecific Antibody to Initiate Phase I Clinical Trial

On December 29, Celltrion announced that its bispecific antibody drug CT-P72/ABP-102, co-developed with US-based Abpro Corporation for the treatment of HER2-positive solid tumors, has obtained approval from the U.S. Food and Drug Administration (FDA) and is set to initiate a Phase I clinical trial. ABP-102 is a bispecific T-cell engager (BiTE) targeting HER2 and CD3, engineered with a tetravalent IgG1-[L]-single-chain variable fragment (scFv) format. This molecule is designed to selectively eliminate tumor cells with high HER2 expression, and by reducing the affinity of its HER2-binding arm, it effectively mitigates off-target toxicities to normal tissues with low HER2 expression. In a corporate statement, Celltrion noted that it plans to start administering the drug to patients in the next year upon completion of relevant preparatory work. Preclinical research data presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November demonstrated that the drug inhibited tumor growth in ...
- Source: drugdu
- 90
- December 30, 2025
Transcenta Group-B and EirGenix Reach Biopharmaceutical Manufacturing Collaboration Agreement

On December 29, Transcenta Holdings Group-B (06628) announced a strategic collaboration and non-exclusive technology licensing agreement with EirGenix. The agreement aims to advance integrated continuous flow manufacturing of biopharmaceuticals and improve global accessibility to affordable biopharmaceuticals. Under the agreement, the company will grant EirGenix a non-exclusive license to its highly integrated continuous flow bioprocess manufacturing (HiCB) platform and provide complete process documentation, core process technologies and experience, and regulatory support services. The company will receive a substantial upfront payment and milestone payments, and will be able to collect future royalties related to the commercialization of the licensed technology. This collaboration is expected to significantly reduce production costs, enabling patients worldwide to access high-quality, affordable biologics. EirGenix plans to use the HiCB platform for its biologics development programs and manufacturing operations, supporting CDMO customers seeking highly integrated continuous flow manufacturing solutions. https://finance.eastmoney.com/a/202512293604195792.html
- Source: drugdu
- 81
- December 30, 2025
China’s first imported PD-L1 subcutaneous formulation approved! Atezolizumab subcutaneous formulation receives NMPA approval for market launch

Atezolizumab is a monoclonal antibody targeting PD-L1. This approval of the subcutaneous (SC) formulation of atezolizumab is based on positive results from the IMscin001 study. IMscin001 was a two-part dose-exploration (Phase Ib) and confirmatory (Phase III) study designed to evaluate the pharmacokinetics of subcutaneous (SC) administration of atezolizumab compared to intravenous (IV) administration in patients with locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). Clinical endpoints included objective response rate (ORR), progression-free survival (PFS) or overall survival (OS), serious adverse events, adverse events of particular concern, grade 3–5 adverse events, infusion-related reactions, and injection site reactions related to safety. The results showed [1] that the C trough and AUC 0-21 d of atezolizumab SC were consistent with those of atezolizumab IV. The PFS [hazard ratio (HR) 1.08 (95% CI [0.82-1.41]], ORR (SC: 12% vs. IV: 10%), and incidence of adverse events (SC: 19.5% vs. IV: 13.9%) were similar ...
- Source: drugdu
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- December 30, 2025
Another biotech company is aiming for a Hong Kong IPO.

Fangtuo Bio, a company specializing in adeno-associated virus (AAV) vector gene therapy, officially submitted its A1 listing application to the main board of the Hong Kong Stock Exchange, becoming the first AAV gene therapy company to apply for listing in the Hong Kong stock market. UBS and Cathay Securities are acting as joint sponsors. 01 Differentiated pipeline layout Founded in 2019, Fangtuo Bio is a clinical-stage gene therapy company with an international footprint. It has built a product portfolio of eight self-developed drug candidates, primarily focusing on ophthalmic and cardiovascular disease areas with significant unmet clinical needs. Among them, two core products (FT-002 and FT-003) and one key product (FT-001) have entered the clinical stage , while the remaining five are in the preclinical and early-stage development stages. FT-002 , used to treat X-linked retinitis pigmentosa (XLRP), is the only therapy of its kind in China to have entered the ...
- Source: drugdu
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- December 30, 2025
CMEF（tHIS ASEAN）

Organiser：Reed Sinopharm, APHM Time：July 28 – 30, 2026 Address：Kuala Lumpur City Centre, Kuala Lumpur, 50088, Malaysia Exhibition hall：Kuala Lumpur Convention Centre Product range: Medical Device Exhibition Area: Medical imaging, in-vitro diagnostics, operating rooms, medical electronic equipment, medical optics, medical robots, medical consumables, orthopedics, medical service disinfection and infection control, international smart health Pharmaceutical and Great Health Exhibition Area: Pharmaceuticals, Chinese herbal medicines, Chinese herbal decoction pieces/medicine-food homology products, traditional Chinese medicine health preservation, traditional Chinese medicine diagnosis and treatment and related equipment, pharmaceutical CRO/CMO/CDMO, personal care products, disinfection and protection products, adult products, medical beauty products, pharmaceutical logistics Rehabilitation and Elderly Care Exhibition Area: Brain science and brain-like research, robots, rehabilitation engineering and treatment equipment, rehabilitation physiotherapy equipment, spinal rehabilitation and health products, cardiopulmonary rehabilitation products, welfare aid products, home medical products and health management products, hearing assistance products, plantar pressure analysis and gait correction products, sleep aid products, ...
- Source: drugdu
- 79
- December 30, 2025
Brazil to launch single-dose dengue vaccination program; Chinese companies help boost vaccine production capacity

“The public is very concerned and eagerly anticipating the fact that dengue fever, an epidemic that has plagued impoverished communities for decades, can finally be ‘solved with a single injection’,” Valesca Mión, health inspector of the Guarulhostra Quelidad community vaccination site in São Paulo state, told reporters on the 26th. She added that she had been notified that, with increased production capacity, the vaccination program would be expanded to cover the entire population. Brazil’s Ministry of Health recently announced that Brazil will begin single-dose dengue fever vaccination by the end of January 2026, with the first batch of 300,000 doses of dengue vaccine developed by the Butantan Institute already delivered. The Brazilian government has initially allocated 368 million reais, planning to provide a total of 3.9 million doses to the public healthcare system. The Butantan Institute is expected to deliver another 1 million doses by the end of January 2026. ...
- Source: drugdu
- 97
- December 29, 2025
Sinovac Biotech’s adsorbent tetanus vaccine officially launched

On December 26, 2025, the first batch of adsorbed tetanus vaccine developed and produced by Beijing Sinovac Biotech Co., Ltd., a subsidiary of Sinovac Biotech, was shipped, officially entering the market. The vaccine, which received registration approval from the National Medical Products Administration in August 2025, represents the culmination of more than four years of research and development efforts, marking a new domestically produced option for tetanus active immunization in my country. Tetanus is an acute toxic disease caused by Clostridium tetani, which enters through breaks in the skin or mucous membranes. Globally, there are approximately one million cases annually, with 300,000 to 500,000 deaths. Without medical intervention, the mortality rate is nearly 100%, and even with standardized treatment, the global mortality rate remains between 30% and 50%. In my country, the overall level of tetanus protection among the adult population is insufficient. Traditional passive immunization agents have limitations such ...
- Source: drugdu
- 79
- December 29, 2025

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