Jinan Zhuocheng Bio-Tech Co., Ltd.

Industry News

API & Biotechnology Industry Updates: GMP Certifications, International Registrations, AI Fermentation Breakthroughs, and Feed Additive Approvals

2026/05/12

01 | Hendi Pharmaceutical Receives Brazil ANVISA GMP Certification for Dexibuprofen API

On May 7, Hubei Hendi Pharmaceutical (301211) announced that its Dexibuprofen API successfully passed on-site GMP inspection by Brazil’s National Health Surveillance Agency (ANVISA).

The GMP certificate is valid until April 22, 2028. This approval creates favorable conditions for the company’s Dexibuprofen API to enter the Brazilian market and further strengthens its international market expansion and global competitiveness.


02 | Shijiazhuang Guqiao Chemical Sees Strong Growth in Cysteamine Hydrochloride Sales

Shijiazhuang Guqiao Chemical, located in Zhao County, has achieved a market share exceeding 75% in cysteamine hydrochloride products.

The company reported an 80% year-on-year increase in Q1 sales and maintained continuous production during holidays. Its products are exported to multiple countries and are gradually expanding into new energy and advanced material sectors.


03 | Brother Enterprises Receives Indian Registration Certificate for Iodixanol API

On May 7, Brother Enterprises Holding (002562) announced that its wholly owned subsidiary Jiangxi Brother Pharmaceutical received an API registration certificate for Iodixanol from India’s Central Drugs Standard Control Organization (CDSCO).

The certificate is valid until April 28, 2029, allowing the product to be officially marketed in India and supporting the expansion of the company’s contrast media API business in international markets.


04 | Guangdong Liguo Pharmaceutical Selected as Provincial Data Intellectual Property Benchmark Case

Guangdong Liguo Pharmaceutical was recently selected as a 2025 Guangdong Provincial Typical Case for Data Intellectual Property.

Its project involving process index data for Cefuroxime Sodium solutions demonstrates how pharmaceutical manufacturing data can be transformed into valuable intellectual property assets, becoming a model case for data utilization and innovation.


05 | North China Pharmaceutical Accelerates Innovation Through Independent R&D and Strategic Collaboration

In recent years, North China Pharmaceutical Group has continued strengthening its “independent R&D + collaborative innovation” strategy.

The company is actively developing antibody drugs, novel vaccines, pet vaccines, and synthetic biology technologies while promoting green manufacturing upgrades.

Key achievements include:

  • Approval and launch of the Class 1 innovative drug Omutiwei Monoclonal Antibody Injection

  • Reduced emissions through enzymatic Cephalexin production technology

  • Improved product yield and safety via microreaction technologies

Supported by national-level research platforms, the company continues enhancing its innovation and commercialization capabilities.


06 | Chuan Ning Biotechnology Achieves AI Fermentation Breakthrough

CSPC Chuan Ning Biotechnology recently achieved significant progress with an AI-based industrial automatic control system jointly developed with Shanghai Jiao Tong University.

The system improved average fermentation tank output by 3%–5%, further strengthening the company’s competitive advantage in biomanufacturing and fermentation technology.

In 2024, the company achieved revenue of RMB 5.758 billion, up 19.38% year-on-year, while net profit increased 48.88% to RMB 1.4 billion.

Its biosynthetic Bisabolol product has reached 99.9% purity and entered the supply chains of internationally recognized companies.


07 | Runhui Biotechnology Achieves Domestic Breakthrough in Elcatonin API

Runhui Biotechnology Weihai recently obtained marketing approval from China’s National Medical Products Administration (NMPA) for Elcatonin API, becoming the first domestic company approved for the product.

Elcatonin is used in osteoporosis treatment and offers improved stability and bioavailability compared with salmon calcitonin.

After more than three years of research and investment exceeding RMB 50 million, the company successfully overcame major challenges in cyclic peptide synthesis, cyclization, and purification technologies.


08 | EU Approves L-Cysteine Series Products as Feed Additives for All Animal Species

On May 8, 2026, the European Commission issued Regulation (EU) 2026/1012, officially authorizing:

  • L-Cysteine

  • L-Cysteine Hydrochloride Monohydrate

  • L-Cysteine Hydrochloride

Produced by Escherichia coli DSM 34232, these products are approved for use as feed additives for all animal species.

The additives are classified under “sensory additives – flavoring compounds,” with authorization valid until May 28, 2036.


09 | Xinhua Pharmaceutical Expands Pipeline in Neurodegenerative Disease Treatment

Shandong Xinhua Pharmaceutical recently received approval from China’s NMPA for Benserazide Hydrochloride API.

The product is a key component in the Parkinson’s disease therapy Levodopa/Benserazide and helps reduce peripheral side effects while improving therapeutic efficacy.

This approval further strengthens the company’s neurodegenerative disease product portfolio and enhances supply chain security for critical APIs.


10 | Jinhe Biotechnology Reports Strong Chlortetracycline Sales Growth

Jinhe Biotechnology stated during recent investor communications that its Chlortetracycline business performed strongly throughout 2025 and Q1 2026.

Key growth drivers include:

  • Expanded domestic application scenarios

  • Stable growth in the U.S. market

  • Significant breakthroughs in new export markets

  • Increased supply capacity supported by the successful launch of its Phase VI project

The company also raised Chlortetracycline prices in both domestic and overseas markets to maintain healthy profit margins.