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【EXPERT Q&A】If the buyer requests the API to provide stability data, is it sufficient for the supplier only to have the COA?

Drugdu.com expert’s response: When exporting Active Pharmaceutical Ingredients (APIs), overseas buyers often request suppliers to provide Certificates of Analysis (COA), product specifications, and GMP-related documentation. However, after initial communication, some customers will further ask for Stability Data to confirm the product’s quality changes under different storage conditions. This can sometimes pose a dilemma for suppliers. While enterprises can provide COAs for recent batches to prove that products meet quality standards at the time of release, buyers still demand long-term stability data, accelerated stability study results, and even inquire about the product’s re-test period and storage conditions. So why are stability data required even when a COA is already available? If an enterprise does not yet have a complete stability study report, will this affect subsequent procurement? COA and Stability Data Demonstrate Different Quality Attributes A COA (Certificate of Analysis) primarily indicates whether the test results of a specific batch of ...
- Source: drugdu
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- November 6, 2026
Boyi Group completes nearly 100 million RMB Series B financing

Recently, Changzhou Boyi Technology Group Co., Ltd. (“Boyi Group”) announced the completion of its Series B1 and B2 financing rounds. Series B1 was exclusively invested by BGI Songhe, while Series B2 was led by Zero2IPO Investment, with participation from Jiangsu Changzhou High-end Functional Materials Industry Special Fund of Funds (Limited Partnership), Jiangsu Huaian Digital Manufacturing Industry Special Fund of Funds (Limited Partnership) under Huaian Venture Capital Group, existing shareholders Jinyu Maowu and BGI Songhe, and strategic investors. The total financing amount for Series B1 and B2 rounds is nearly RMB 100 million. The funds raised will primarily be used for the research and development of new materials and intelligent protein purification systems, as well as accelerating global commercial promotion and implementation. Founded in January 2022, Boyi Group owns three major brands: Tiandi Renhe, Boyi Bio, and ACE. Its business covers high-performance bio-purification packing materials, high-efficiency life science research reagents, high-standard ...
- Source: drugdu
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- November 6, 2026
Net profit surges by 588%! A century-old traditional Chinese medicine brand successfully shifts gears.

Against the backdrop of overall pressure on the traditional Chinese medicine industry in 2026, Jiuzhitang stood out with a third-quarter report showing a year-on-year increase of over 588% in net profit attributable to the parent company . A rare “double increase” report card In the first three quarters of 2026, Jiuzhitang achieved operating revenue of RMB 2.186 billion, a year-on-year increase of 34.34%; net profit attributable to the parent company reached RMB 304 million, a year-on-year increase of 100.33%; and net profit after deducting non-recurring gains and losses increased by 110.63%, outpacing the growth rate of net profit attributable to the parent company, indicating that the growth was mainly driven by the main business. Even more noteworthy is the performance in the third quarter: net profit attributable to the parent company was 53.3756 million yuan, a year-on-year increase of 588.01%, and the gross profit margin rose by 1.72 percentage points ...
- Source: drugdu
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- November 6, 2026
Singapore approves CMS’s ruxolitinib phosphate cream for nonsegmental vitiligo

China Medical System (00867.HK) announced on November 4 that Singapore’s Health Sciences Authority had approved Lumirix® (ruxolitinib phosphate cream) for nonsegmental vitiligo with facial involvement in adults and adolescents aged 12 and older. According to the company, it was Singapore’s first and, at the time, only topical prescription treatment that directly targets the underlying disease mechanism. Source: http://finance.eastmoney.com/a/202611043922060662.html
- Source: drugdu
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- November 6, 2026
China accepts United Laboratories’ semaglutide injection filing for weight management

The United Laboratories (03933) announced on November 4 that China’s NMPA had accepted a marketing application from its wholly owned Zhuhai biologics subsidiary for semaglutide injection for weight management. The article describes uses of semaglutide injection in glycemic control in type 2 diabetes, long-term weight management in people with obesity or overweight, and reducing the risk of related cardiovascular events. The United Laboratories said the filing broadens its planned indications for the product. Its GLP-1 pipeline includes both innovative drugs and biosimilars. Source: http://finance.eastmoney.com/a/202611053922758066.html
- Source: drugdu
- 75
- November 6, 2026
Daridorexant receives US FDA Breakthrough Therapy designation for pediatric insomnia

According to Simcere Pharmaceutical on November 5, the US FDA granted daridorexant Breakthrough Therapy designation for insomnia disorder in children and adolescents aged 10 to 18. The article cites study findings that the 50 mg dose showed a safety profile similar to placebo, with no drug abuse-related adverse events reported during treatment. Daridorexant is a dual orexin receptor antagonist that suppresses wake-promoting signaling by blocking orexin A and B from binding to their receptors. In November 2022, Simcere obtained exclusive development and commercialization rights in Greater China from Switzerland’s Idorsia. China approved the drug in June 2025 for adults with insomnia characterized by difficulty falling or staying asleep. Source: http://finance.eastmoney.com/a/202611053923706422.html
- Source: drugdu
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- November 6, 2026
Menovo subsidiary passes first US FDA on-site inspection for tildipirosin API

Menovo (603538) disclosed on November 6 that its controlled subsidiary, Xuancheng Menovo, received a US FDA inspection report on November 4 confirming that it had passed its first FDA on-site inspection for tildipirosin API. The preapproval cGMP inspection ran from June 22 to 26, 2026, and covered quality, materials, manufacturing, facilities and equipment, packaging and labeling, and laboratory controls. The company said the inspection outcome would support its international expansion. Menovo develops, manufactures and sells specialty APIs and finished dosage forms. In the first nine months of 2026, revenue rose 29.00% year on year to RMB 1.441 billion, and net profit attributable to shareholders rose 8.54% to RMB 104 million. Source: http://finance.eastmoney.com/a/202611063924413520.html
- Source: drugdu
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- November 6, 2026
Grand Pharma’s investigational eye drop meets primary endpoint in global Phase III trial

Grand Pharma (00512.HK) announced on November 5 that CBT-001 (GPN00153), an investigational eye drop, met the primary endpoint in a multinational, multicenter Phase III trial for pterygium. The company reported efficacy at both doses and statistically significant improvements in redness and lesion size. The findings could support a future marketing application. CBT-001 is a multikinase inhibitor designed to target fibrovascular growth by blocking pathways involved in angiogenesis and fibrosis. Earlier studies reported sustained reductions in vascular growth and redness, with a favorable safety profile. The article also discusses potential use across disease severities and in preventing postoperative recurrence. Pterygium can grow from the conjunctiva onto the cornea and impair vision. The article reports that no drug had been approved specifically for the condition and cites a postoperative recurrence range of 31% to 83% and a global prevalence estimate of 10.2%. Frost & Sullivan estimated that the global patient population would ...
- Source: drugdu
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- November 6, 2026
Hunan Warrant Pharmaceutical subsidiary wins approval for esomeprazole magnesium API

Hunan Warrant Pharmaceutical (688799) disclosed on the evening of November 5 that China’s National Medical Products Administration (NMPA) had approved the marketing application for esomeprazole magnesium active pharmaceutical ingredient (API) from its wholly owned chiral pharmaceuticals subsidiary. The API is used in formulations including gastro-resistant esomeprazole magnesium capsules. The filing lists gastroesophageal reflux disease, eradication of Helicobacter pylori in combination with appropriate antibacterial therapy, and use in patients who require ongoing nonsteroidal anti-inflammatory drug therapy. Source: http://finance.eastmoney.com/a/202611053923758717.html
- Source: drugdu
- 39
- November 6, 2026
BioPlus-Interphex Korea

Organiser：Reed Exhibitions Group Time：October 28th – October 30th, 2026 Address：513 Yeongdong-daero, Gangnam District, Seoul, South Korea Exhibition hall：COEX Convention & Exhibition Center Product range: Pharmaceutical Raw Materials and Ingredients: APIs, intermediates, additives, functional raw materials, natural extracts, fine chemicals, business outsourcing, contract processing, OEM formulations Biopharmaceuticals: Laboratory equipment and reagents, biological preparations, drug R&D, biotechnology, genomics About BioPlus-Interphex Korea： BioPlus-Interphex Korea in Seoul, South Korea is a biopharmaceutical exhibition that showcases the “value chain of biopharmaceuticals” and proposes overseas expansion through the establishment of a global business network. It is a collaborative event between ‌KoreaBIO‌, the leading enterprise in South Korea’s bioindustry, and INTERPHEX, an international pharmaceutical exhibition brand. Aiming to enhance the brand value of South Korea’s bioindustry and actively engage in exchanges with the global market, BioPlus-Interphex Korea has been hosted by the Korea Bio Industry Association since 2015. It covers R&D technologies, manufacturing technologies and ...
- Source: drugdu
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- November 5, 2026

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