media – Page 17 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

Breakthrough! Changshan Pharmaceutical’s enoxaparin sodium injection receives FDA approval in the United States, marking a new chapter in its overseas market journey!

Recently, Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (stock abbreviation: Changshan Pharmaceutical, stock code: 300255 ) reached a significant milestone – the ANDA application for the generic version of its core drug, enoxaparin sodium injection , was officially approved by the U.S. Food and Drug Administration ( FDA ), with ANDA number 218775. This marks the first time Changshan Pharmaceutical’s heparin preparations have passed FDA certification in the United States, signifying that the company’s product quality has aligned with international standards and successfully obtained its “ticket” to enter the U.S. market. As a commonly used antithrombotic drug in clinical practice, enoxaparin sodium injection has indications covering multiple key scenarios: prevention of venous thromboembolic diseases associated with orthopedic and general surgery, reducing the risk of postoperative thrombosis; treatment of existing deep vein thrombosis (including cases with non-severe pulmonary embolism, excluding pulmonary embolism requiring surgery or thrombolytic therapy); treatment of unstable angina and ...
- Source: drugdu
- 103
- January 15, 2026
Kelun and Grand Pharmaceuticals compete for the first generic version of a blockbuster heart failure drug!

On October 16, 2025, Hubei Yuanda Tianming Pharmaceutical, a wholly-owned subsidiary of Grand Pharmaceutical Group, had its marketing application for ivabradine hydrochloride oral solution, submitted as a Class 3 chemical drug, accepted. Less than three months later, on January 9, 2026, Hunan Kelun Pharmaceutical also submitted a marketing application for the same product, becoming the second company to enter the market. This signifies the official start of the battle for the first generic version of ivabradine hydrochloride oral solution . Currently, only regular tablets of ivabradine hydrochloride are available on the Chinese market ; the oral solution formulation has not yet been approved. 01 Peak revenue within the hospital exceeded 300 million yuan, and the original drug led the market with a 57.43% market share. Ivabradine hydrochloride was originally developed by Servier in France . Its tablets were first approved for marketing in France in October 2005, in the United ...
- Source: drugdu
- 109
- January 15, 2026
Xuesaitong soft capsules are the company’s exclusive core dosage form

January 14th – Kunming Pharmaceutical GroupIn response to investor inquiries on the interactive platform, the company stated that Xuesaitong soft capsules are its exclusive core dosage form. As a liquid dosage form, soft capsules offer faster absorption rates, and the simplified formulation and single excipient composition help optimize product safety from the source, creating a differentiated advantage. The company continues to explore the application of Xuesaitong soft capsules in precise indications and in combination with other drugs. Among these, the core product “Lixuwang” Xuesaitong soft capsules combined with aspirin in the integrated traditional Chinese and Western medicine treatment plan “Ali Therapy” has achieved good academic results. Simultaneously, leveraging its comprehensive R&D pipeline and technological reserves, the company continuously iterates and upgrades existing products to meet the medication needs of different patient groups and consolidate and enhance its long-term competitiveness. Furthermore, the company highly values the medication experience and needs of ...
- Source: drugdu
- 86
- January 15, 2026
Hualan Biological’s investee company’s application for marketing authorization of adalimumab injection has been accepted

On January 13, Hualan Biological Engineering Co., Ltd.The company issued an announcement regarding its investee company, Hualan Ankang Biotechnology Co., Ltd.The company (formerly known as Hualan Gene Engineering Co., Ltd.) has received the Acceptance Notice (Acceptance No.: CXSS2600006) from the National Medical Products Administration for its application for registration and marketing authorization of adalimumab injection for domestic production. This drug is a biosimilar used to treat various autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, and Crohn’s disease. The announcement stated that, as of now, Shenzhou Cell　　has [a certain number of] [products/services] in China.Adalimumab injection from eight companies, including an engineering company, has been approved for marketing. If Hualan Ankang’s product is ultimately approved for marketing, it will enrich its product portfolio and is expected to add a new profit growth point. https://finance.eastmoney.com/a/202601133616721398.html
- Source: drugdu
- 89
- January 15, 2026
Gan & Lee Pharmaceuticals’ glargine insulin injection receives marketing authorization from the European Commission

January 14th that Gan & Lee Pharmaceuticals…(603087) announced that the company and its wholly-owned European subsidiary, Gan & Lee Pharmaceuticals Europe Ltd., recently received a notification from the European Commission that the company’s product, insulin glargine injection (trade name: Ondibta), has obtained marketing authorization in the European Union, Iceland, Liechtenstein and Norway for the treatment of diabetes in adults, adolescents and children aged 2 years and older. https://finance.eastmoney.com/a/202601143619110685.html
- Source: drugdu
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- January 15, 2026
Application for registration of erythromycin lactobionate for injection accepted

Fosun Pharma (600196) announced on January 14 that its subsidiary, Suzhou Erye Pharmaceutical Co., Ltd., has recently had its drug registration application for injectable erythromycin lactobionate accepted by the National Medical Products Administration. This drug is a chemical drug intended for use in treating infections caused by specific susceptible strains of microorganisms when oral administration is not feasible or the severity of the infection requires rapid attainment of high erythromycin serum concentrations; for the prevention of initial rheumatic fever; for the prevention of recurrence of rheumatic fever; and for the prevention of bacterial endocarditis. https://finance.eastmoney.com/a/202601143619173587.html
- Source: drugdu
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- January 15, 2026
High-potency rabies vaccine completes Phase III clinical trials

On January 15, Aim Vaccine (06660) issued an announcement stating that its iterative process high-titer human diploid rabies vaccine has successfully completed Phase III clinical field work. This product demonstrated high levels of protective antibodies in animal trials, with a significantly higher potency than existing human diploid rabies vaccines. Compared to traditional first-generation human diploid rabies vaccines, the company’s vaccine has overcome technical bottlenecks such as low viral titer and low yield, optimized purification processes, and significantly improved product quality and safety. According to Frost & Sullivan, China’s rabies vaccine market is projected to reach RMB 14.8 billion by 2030. This vaccine offers flexible administration methods and has the capacity for large-scale production, making it expected to become the preferred choice for vaccination institutions, further solidifying the company’s market position and promoting sustainable development. https://finance.eastmoney.com/a/202601153619836997.html
- Source: drugdu
- 100
- January 15, 2026
SEACare 2026

Organiser：Malaysia ABC Exhibition Company Time：April 28 – 30, 2026 Address：8, Jalan Dutamas 2, Kompleks Kerajaan, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Exhibition hall：Malaysia International Trade and Exhibition Centre Product range: Medical and Hospital Institution Equipment: institutional equipment, dental products, disposable items, medical staff attire, nursing supplies, etc. Electronic Medical Equipment: anesthesia instruments, audiometers, blood pressure monitors, laser equipment, surgical instruments, scanning devices Medical Laboratories: analytical instruments, microbiology, blood analysis, biochemical equipment, etc. Rehabilitation and Home Care: assistive and physical therapy equipment, rehabilitation devices, orthotic devices, sports facilities, wheelchairs, etc. Pharmaceutical Products: consumer products and herbal preparations, etc. About SEACare 2026 ： The Malaysia Kuala Lumpur Medical Equipment and Rehabilitation Exhibition (SEACare) is one of the most renowned exhibitions in the region and serves as a crucial avenue for Chinese enterprises to explore the Malaysian market. It undoubtedly presents an excellent opportunity for our medical institutions to gain access to ...
- Source: drugdu
- 78
- January 15, 2026
First Dry Powder Inhaler from a Chinese Pharmaceutical Company Approved by FDA for U.S. Marketing

On January 12, 2026 (U.S. time), Runsheng Pharmaceutical Co., Ltd. (hereinafter referred to as “Runsheng Pharmaceutical”) announced exciting news: its submitted product Fluticasone Propionate and Salmeterol Inhalation Powder (USAN: Fluticasone Propionate and Salmeterol Inhalation Powder USP, ANDA No.: 214464) has officially obtained marketing approval from the U.S. Food and Drug Administration (FDA). This marks the first-ever FDA approval of a dry powder inhaler (DPI) independently developed by a Chinese pharmaceutical company, representing a pivotal breakthrough for China’s high-end complex drug formulations to penetrate the international mainstream market. Formulated as a fixed-dose combination therapy integrating a bronchodilator and an inhaled corticosteroid, this product is specifically indicated for the maintenance treatment of reversible airway obstructive diseases such as asthma in adults and pediatric patients. Picture source: Boteng Pharmaceuticals 01 Originator Background: The Market Foundation of a Multi-Hundred-Billion-Dollar Product The originator of this product is Advair® Diskus®, developed by the UK-based GlaxoSmithKline (GSK). ...
- Source: drugdu
- 98
- January 14, 2026
Sino Biopharmaceutical Acquires Hangzhou Hygieia Biomedical

On January 13, Hong Kong-listed pharmaceutical leader Sino Biopharmaceutical (1177.HK) issued an announcement, declaring the full acquisition of domestic siRNA innovative drug company Hangzhou Hygieia Biomedical for a total price of RMB 1.2 billion. According to available data, Hygieia Biomedical was established in 2018 and is committed to providing innovative siRNA products with ultra-long action and low dosage advantages. The core R&D team, led by founder and chief scientist Dr. Cui Kunyuan, possesses over 20 years of professional experience in the development of small nucleic acid drugs, securing more than 50 core patents covering multiple delivery systems. Leveraging this profound technical accumulation, Hygieia has established six major intrahepatic and extrahepatic delivery platforms. Currently, four innovative drug candidates have advanced into the clinical stage, with over 20 projects in the preclinical phase, and the company has achieved two external licensing agreements. These pipelines hold significant potential as global First-in-Class (FIC) and ...
- Source: drugdu
- 84
- January 14, 2026

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