近期多款药品获批 华海药业制剂业务快速发展

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval for the registration of Fumaric Acid Quetiapine Sustained-Release Tablets, enhancing its product line in the treatment of mental disorders and increasing market competitiveness [2] Group 1: Product Approvals and Market Potential - The Fumaric Acid Quetiapine Sustained-Release Tablets are developed by AstraZeneca and are primarily used for treating schizophrenia and depressive episodes in bipolar disorder, with a projected domestic market sales of approximately 451 million yuan in 2024 [2] - Huahai Pharmaceutical has recently received multiple drug approvals, indicating strong R&D capabilities and pipeline efficiency, including Dagagliflozin Metformin Sustained-Release Tablets and Tolvaptan Tablets, with projected sales of approximately 195 million yuan and 497 million yuan respectively in 2024 [2] Group 2: Business Growth and Revenue - The formulation business is becoming a growth engine for Huahai Pharmaceutical, with revenue expected to increase from 4.721 billion yuan in 2022 to 5.759 billion yuan in 2024, raising its revenue share from 57.11% to 60.32% [3] - The company has 105 formulation products approved by the US ANDA and 79 products approved by the National Medical Products Administration, covering various therapeutic areas including cardiovascular, mental disorders, and infections [3] Group 3: Strategic Initiatives and Innovations - Huahai Pharmaceutical is committed to advancing its biological innovation drug strategy, with significant investments in R&D for innovative drugs, particularly in oncology and autoimmune diseases [4] - The company’s subsidiary, Shanghai Huatai Biological Pharmaceutical Co., Ltd., is preparing to submit an ANDA for its HB0034 project, aimed at treating generalized pustular psoriasis, with expected approval next year [4]