Hinova Pharmaceuticals (SH:688302) Xin Jing Bao·2025-05-30 13:00Core Viewpoint - Haichuang Pharmaceutical has received approval from the National Medical Products Administration for its self-developed new drug, Dihydroenzalutamide soft capsule (Haina An), marking its first product approval after a challenging application process [2][3]. Group 1: Product Approval and Market Position - Dihydroenzalutamide soft capsule is approved for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after receiving abiraterone acetate and chemotherapy, and have not previously received new androgen receptor inhibitors [3]. - This drug is the first innovative drug in China targeting this patient population and represents Haichuang's first approved product [3][4]. - The company plans to adopt a combined approach of building its own team and external collaborations for market promotion, aiming to establish a commercial team and network quickly [3]. Group 2: Financial Performance and Challenges - Since its listing in April 2022, Haichuang Pharmaceutical has accumulated losses exceeding 800 million yuan, with no profits reported to date [2][8]. - The company reported revenues of 1.651 million yuan in 2022, 0 yuan in 2023, and 366,800 yuan in the first quarter of 2025, with net losses of 302 million yuan, 294 million yuan, 200 million yuan, and 32.1 million yuan respectively [8]. - The second-largest shareholder, Chengdu Yingchuang Power Venture Capital Co., Ltd., has frequently reduced its holdings, cashing out approximately 160 million yuan since June 2023 [8]. Group 3: Research and Development Status - Haichuang Pharmaceutical is facing delays in the development of multiple products, with several projects paused [5][7]. - The company had planned to use the 999.5 million yuan raised during its IPO for R&D and production base construction, but has since encountered various challenges, including the suspension of overseas clinical trials for some projects [6][7]. - The timelines for three in-development drugs (HP501, HP518, HP537) have been extended from January 2025 to December 2026 due to various reasons [7]. Group 4: Competitive Landscape - The domestic AR inhibitor market is primarily dominated by second-generation inhibitors like Apalutamide and Enzalutamide, which are gradually replacing first-generation drugs [4]. - Dihydroenzalutamide soft capsule is the second domestically developed second-generation AR inhibitor and is expected to face intense competition from Enzalutamide and its generics [4][8].