Fusen Pharmaceutical’s Piracetam Injection Approved for Marketing in China
Fusen Pharmaceutical Company Limited (Stock Code: 1652) has made a significant announcement that is likely to attract investor attention and potentially impact its share price. The company’s wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Company Limited, has received official marketing approval from the National Medical Products Administration of the PRC (NMPA) for its new product, Piracetam Injection.
Key Highlights of the Announcement
- Product Approval: Piracetam Injection is now approved for marketing in China, expanding the company’s neurological disorder product pipeline.
- Indications: The drug is indicated for the treatment of memory impairment and mild to moderate cerebral dysfunction caused by acute and chronic cerebrovascular diseases, traumatic brain injury, various toxic encephalopathies, and for children with delayed intellectual development.
- Mechanism of Action: Piracetam Injection is a cerebral metabolism-enhancing agent, the first of the “racetam” class based on the neurotransmitter GABA. It activates adenylate kinase, increasing the ATP/ADP ratio in the brain, enhancing absorption and utilization of amino acids, proteins, and glucose, promoting cerebral metabolism, and increasing resistance to hypoxia. It also offers mitochondrial protection against oxidative stress.
- Clinical Recognition: Piracetam is widely used in clinical practice for its efficacy and low side effect profile. It is recommended in several authoritative Chinese clinical guidelines for Alzheimer’s disease, acute ischemic stroke, and post-stroke aphasia management.
- Market Classification: The product is listed as a Class B drug under the National Healthcare Security Administration of the PRC, making it eligible for reimbursement in China and broadening market access.
- Market Opportunity: According to Menet data, Piracetam Injection sales in China’s major terminal channels and key markets surpassed RMB250 million in 2025, underscoring a substantial market opportunity.
- Product Specifications: The Group’s existing 20ml:8mg specification has long-standing market recognition. The new approvals for 5ml:1mg and 15ml:3mg specifications will further address diverse clinical needs, strengthening the product’s competitive positioning.
- Strategic Importance: The launch of Piracetam Injection is expected to enhance Fusen Pharmaceutical’s portfolio in neurological disorders, providing more treatment options for patients with cerebrovascular diseases and cognitive impairment.
- Leadership Statement: The announcement was issued by the Board and signed by Chairman and Executive Director Mr. Cao Zhiming on 16 June 2026.
Potential Impact on Shareholders and Share Value
- Growth Potential: With proven market demand and broad clinical endorsements, the marketing approval for Piracetam Injection positions Fusen Pharmaceutical for revenue growth and market share expansion in China’s neurological treatment sector.
- Pipeline Strengthening: This approval adds a high-profile therapy to Fusen’s pipeline, supporting long-term strategic growth in a large and growing therapeutic area.
- Reimbursement and Market Access: Being a Class B drug enhances accessibility, which can accelerate uptake and drive sales volumes.
- Investor Considerations: The successful regulatory approval of a product with substantial existing market demand and strong clinical recommendations may serve as a positive catalyst for the company’s share price.
Management and Board Composition
The Board comprises: Mr. Cao Zhiming (Chairman), Mr. Hou Taisheng, Mr. Chi Yongsheng, Ms. Meng Qingfen (executive Directors), and Mr. Lee Kwok Tung Louis, Dr. To Kit Wa, and Mr. Yu Ho Ming (independent non-executive Directors).
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or seek professional advice before making investment decisions.
富森製藥吡拉西坦注射液獲國家藥監局批准上市
富森製藥有限公司（股份代號：1652）公布其全資子公司嘉亨（珠海橫琴）醫藥科技有限公司所研發的吡拉西坦注射液獲得國家藥品監督管理局（NMPA）批准於中國上市。此消息具潛在股價推動力，值得股東關注。
公告重點詳情
- 產品批准：吡拉西坦注射液正式獲批上市，進一步擴充公司神經系統疾病產品線。
- 適應症：用於治療因各類急慢性腦血管疾病、腦外傷、各種中毒性腦病引致的記憶障礙及輕中度腦功能障礙，亦可用於智力發育遲緩的兒童。
- 作用機制：吡拉西坦為首個基於GABA結構開發的「拉西坦」類藥物，能激活腺苷酸激酶，提升腦部ATP/ADP比例，加強氨基酸、蛋白質及葡萄糖的吸收利用，促進腦細胞代謝，提升大腦對缺氧的抗性，並具抗氧化保護線粒體的作用。
- 臨床認可：吡拉西坦因療效顯著及副作用少，廣泛應用於臨床，並被多項權威中國診治指引推薦用於阿茲海默症、急性缺血性腦卒中及卒中後失語症管理。
- 市場分類：該產品在國家醫保目錄中屬於乙類藥物，有助於提高市場可及性及報銷覆蓋。
- 市場機遇：根據Menet數據，2025年吡拉西坦注射液於中國三大終端及六大重點市場銷售額超過人民幣2.5億元，市場潛力巨大。
- 產品規格：集團現有20ml:8mg規格市場認可度高，新獲批的5ml:1mg及15ml:3mg規格將進一步滿足不同臨床需求，提升競爭力。
- 戰略意義：本產品上市將進一步豐富公司在神經系統疾病領域的產品組合，為腦血管疾病及認知障礙患者提供更多治療選擇。
- 管理聲明：公告由董事會主席及執行董事曹志明先生於2026年6月16日發佈。
對股東及股價的潛在影響
- 增長動力：隨著市場需求明確及臨床指引推薦，吡拉西坦注射液獲批上市有望推動公司收入增長，擴大市場份額。
- 管線增強：該產品的獲批進一步鞏固富森製藥於大型神經疾病治療領域的長遠發展。
- 醫保覆蓋：乙類醫保藥物身份有助於加快市場滲透，帶動銷售增長。
- 投資者關注：一款市場需求大、臨床認可度高的新產品獲批，預計將成為公司股價的正面催化劑。
管理層及董事會組成
董事會成員包括：曹志明先生（主席）、侯太生先生、池永生先生、孟清芬女士（執行董事），以及李國東先生、杜傑華博士、余浩明先生（獨立非執行董事）。
免責聲明：本文章僅供參考，不構成任何投資建議。投資者應自行評估或尋求專業意見後方作投資決定。
