Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has launched its self-developed innovative anti-cancer drug, Dihydro-Enzalutamide soft capsule, marking a significant milestone in its development journey [2][3] Group 1: Product Launch and Clinical Significance - Dihydro-Enzalutamide soft capsule is recognized as a new type of androgen receptor antagonist (ARi) and has shown significant clinical value, particularly in treating metastatic castration-resistant prostate cancer (mCRPC) [2] - Clinical studies indicate that Dihydro-Enzalutamide significantly improves disease progression and survival rates while demonstrating excellent safety profiles, with no adverse events such as falls or seizures reported [2] - Experts suggest that Dihydro-Enzalutamide has the potential to be moved forward in treatment protocols for metastatic hormone-sensitive prostate cancer (mHSPC) [2][3] Group 2: Company Development and Future Plans - The inauguration of Haichuang Pharmaceutical's headquarters and the rapid nationwide supply of Dihydro-Enzalutamide signify a critical leap from research innovation to industrial empowerment [3] - The company focuses on developing innovative drugs for cancer and metabolic diseases and plans to accelerate the global rollout of multiple anti-cancer and metabolic disease drugs [3] - Haichuang Pharmaceutical's chairman emphasized the importance of patient-centered research and the collective effort of employees and partners in achieving this milestone [3]

Group 1 - The announcement indicates that Chengdu Yingchuang Power Venture Capital Co., Ltd. has reduced its shareholding in Haichuang Pharmaceutical Co., Ltd. from 6.28% to 6.00%, a decrease of 0.28% [1][2] - The reduction in shareholding was executed through centralized bidding transactions, with a total of 276,133 shares sold [1] - The reduction has triggered a change in equity that touches the 1% threshold, but the overall reduction plan has not yet been fully implemented [1][2] Group 2 - The announcement confirms that the equity change does not violate any prior commitments or plans made by the shareholder [1] - The company has disclosed that there are no other shareholders acting in concert with Chengdu Yingchuang Power Venture Capital Co., Ltd. [1] - The specific details of the share reduction plan were previously disclosed on May 14, 2025, in a separate announcement [1]

证券代码：688302 证券简称：海创药业 公告编号：2025-031 海创药业股份有限公司 关于持股5%以上股东权益变动触及1%刻度的提示性公告 信息披露义务人成都盈创动力创业投资有限公司保证向本公司提供的信息真实、 准确、完整，没有虚假记载、误导性陈述或重大遗漏。 本公司董事会及全体董事保证公告内容与信息披露义务人提供的信息一致。 重要内容提示： | 权益变动方向 | 比例增加□ | | 比例减少 | | --- | --- | --- | --- | | 权益变动前合计比例 | 6.28% | | | | 权益变动后合计比例 | 6.00% | | | | 本次变动是否违反已作出的承 诺、意向、计划 | 是□ | 否 | | | 是否触发强制要约收购义务 | 是□ | 否 | | 一、 信息披露义务人及其一致行动人的基本信息 1.身份类别 | | □控股股东/实际控制人及其一致行动人 | | --- | --- | | | 其他 5%以上大股东及其一致行动人 | | 投资者的身份 | □合并口径第一大股东及其一致行动人（仅适用于无控股股东、 | | | 实际控制人） | | | □其他_/_ | ...

Core Viewpoint - The successful launch of the self-developed Class 1 anti-cancer drug, Deuteroenzalutamide, by Haichuang Pharmaceutical marks a significant milestone for the company and its mission to create effective medicines for the benefit of society [1][2]. Company Overview - Haichuang Pharmaceutical is a global innovative drug company focused on cancer and metabolic diseases, with four core technology platforms: PROTAC targeted protein degradation, deuterated drug development, targeted drug discovery and validation, and translational medicine [2]. - The company has been recognized in two national "Major New Drug Creation" science and technology projects and several provincial and municipal research projects, with eight products in development and one product already launched [2]. Product Details - Deuteroenzalutamide soft capsules are designed for adult patients with metastatic castration-resistant prostate cancer who have experienced disease progression after treatment with abiraterone acetate and chemotherapy, and who have not previously received new androgen receptor inhibitors [1]. - Prostate cancer is the second most common cancer among men globally, with 1.467 million new cases reported in 2022, and the incidence in China has been rising, with 134,000 new cases in the same year [1]. Market Launch - The product received approval from the National Medical Products Administration at the end of May and began national distribution in late June, with the first prescription issued shortly after [2]. - Patients can purchase the product at major provincial capital DTP pharmacies with a doctor's prescription, indicating its significant clinical value and urgent demand [2].

Group 1 - The core point of the news is that Haichuang Pharmaceutical has launched its self-developed Class I anti-cancer drug, Deuteroenzalutamide soft capsules, which are now available nationwide for patients with metastatic castration-resistant prostate cancer [1][2] - The drug is specifically designed for adult patients who have progressed after treatment with Abiraterone acetate and chemotherapy, and who have not previously received new androgen receptor inhibitors [1] - Prostate cancer is the second most common cancer among men globally, with 1.467 million new cases reported in 2022, and China saw 134,000 new cases in the same year, indicating a rising trend in incidence [1] Group 2 - Deuteroenzalutamide soft capsules are the first innovative drug approved in China for patients with metastatic castration-resistant prostate cancer, highlighting its clinical significance and urgent demand [1][2] - The company emphasizes its commitment to ensuring the quality and stable supply of the drug while accelerating the development of its rich pipeline of innovative therapies for global patients [2] - The drug reportedly shows superior safety compared to other endocrine therapies, significantly reducing the incidence of central nervous system adverse events and common complications in elderly patients [1]

Group 1 - The A-share market's innovative drug concept stocks have shown strong performance, with the innovative drug sector index reaching a historical high [1] - Notable individual stock performances include Xinghao Pharmaceutical rising over 25%, RuiZhi Pharmaceutical hitting a 20% limit up, and Changshan Pharmaceutical reaching a historical high [1][2] - The overall pharmaceutical sector has experienced a prolonged adjustment period, resulting in low valuations and underweight public holdings, indicating potential for recovery and structural opportunities [2] Group 2 - Specific stock performances include: - Xinghao Pharmaceutical: 25.82% increase, market cap of 3.045 billion [2] - RuiZhi Pharmaceutical: 19.98% increase, market cap of 5.801 billion [2] - Changshan Pharmaceutical: 19.97% increase, market cap of 47.9 billion [2] - Shutaishen: 12.12% increase, market cap of 15.6 billion [2] - The report from China Galaxy Securities suggests that the pharmaceutical market is expected to see continuous recovery and that innovative drug companies will benefit from policy support and improved payment conditions by 2025 [2]

Core Viewpoint - Haichuang Pharmaceutical (688302) is focusing on the sales strategy of its drug, Dihenzalutamide, which is expected to fill a clinical gap in treating specific mCRPC patients and has significant market potential in China [1][2]. Group 1: Sales Strategy and Market Position - The sales strategy for Dihenzalutamide revolves around a "medical-market-access-sales" four-wheel drive model, emphasizing the establishment of new standards and accumulation of real-world data [1]. - The drug has a differentiated competitive advantage compared to competitors, significantly improving the primary endpoint by extending rPFS by 5.5 months and reducing the risk of imaging progression or death by 42% [1][2]. - The prostate cancer market in China is projected to reach 50 billion by 2030, indicating substantial market potential for Dihenzalutamide [1]. Group 2: Clinical Research and Development - Dihenzalutamide has been included in the CSCO guidelines in 2023 and is expected to be included again after product approval in 2025 [2]. - The company has been exploring protein degradation technology since 2016 and has developed a mature PROTC and molecular glue technology platform [2]. - HP518 is the first oral R PROTC drug in clinical trials in China, with the first subject enrolled in a Phase II trial expected to complete by December 2024 [2]. Group 3: Financial and Operational Outlook - The company plans to maintain annual R&D expenditures at around 200 million over the next 2-3 years, with cash reserves of 880 million as of March 2025 [2]. - The company is considering refinancing needs based on product commercialization and progress of ongoing projects [2]. - An experienced business development team has been established overseas to advance various business development activities [2].

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][37]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 2.21% in the week from May 26 to May 30, ranking second among 31 industries in the Shenwan index and outperforming the CSI 300 index by 3.29 percentage points. Year-to-date, the sector has risen by 6.61%, ranking sixth among the 31 industries and outperforming the CSI 300 index by 9.02 percentage points [4][13][15]. - The current PE valuation for the pharmaceutical and biotechnology sector is 27.98 times, which is at the historical median level, with a valuation premium of 137% compared to the CSI 300 index. The top three sub-sectors in terms of growth are chemical pharmaceuticals, biological products, and medical services, with increases of 3.83%, 3.14%, and 2.46% respectively [4][22][15]. Summary by Sections Market Performance - The pharmaceutical and biotechnology sector's performance for the week of May 26 to May 30 was a 2.21% increase, ranking second among 31 industries, and outperforming the CSI 300 index by 3.29 percentage points. Year-to-date, the sector has increased by 6.61%, ranking sixth and outperforming the CSI 300 by 9.02 percentage points. The top three sub-sectors were chemical pharmaceuticals (3.83%), biological products (3.14%), and medical services (2.46%) [4][13][15]. Industry News - On May 29, the National Medical Products Administration (NMPA) approved 11 innovative drugs, with 9 being domestically developed, showcasing the increasing innovation capability of China's pharmaceutical industry. Additionally, during the 2025 American Society of Clinical Oncology (ASCO) annual meeting, significant clinical data was presented for various treatments, indicating the growing recognition of domestic innovative drug companies [5][29][32]. Investment Recommendations - The report suggests focusing on the innovative drug sector, which is seen as the most certain and leading sub-sector within the pharmaceutical and biotechnology industry. It also recommends exploring investment opportunities in medical devices, traditional Chinese medicine, chain pharmacies, and medical services. Specific stock recommendations include Beida Pharmaceutical, Teva Biopharma, Qianhong Pharmaceutical, Lingrui Pharmaceutical, and Lao Baixing, with additional stocks to watch including Kelun Pharmaceutical, Rongchang Biopharma, Kaili Medical, Huaxia Eye Hospital, and Baipusais [6][35].

Group 1 - Mingyuan Investment recently conducted research on a listed company, Haichuang Pharmaceutical, which has received approval for its core product, Deutetrabenazine soft capsules, a first-class new drug for treating mCRPC, significantly extending patients' progression-free survival [1] - The clinical trial for HP515, aimed at treating MSH, is currently ongoing in China, with preliminary data indicating good safety of the drug [1] - The company is also conducting a Phase II clinical trial for HP518, which has received fast track designation in the United States [1] - Haichuang Pharmaceutical has established a four-wheel drive commercialization strategy, combining self-built teams with external collaborations to comprehensively advance product commercialization preparations [1] Group 2 - Mingyuan Investment Management Co., Ltd. was established in 2014 in Shanghai, with a registered capital of 10 million yuan, founded by Dr. Qiu Huiming, who has extensive experience in hedge funds on Wall Street [2] - The company has obtained the private securities investment fund manager qualification and observation member qualification approved by the Asset Management Association of China [2] - Mingyuan Investment focuses on quantitative investment, leveraging strong data mining, statistical analysis, and software development capabilities to build a systematic trading and asset management platform [2] - The investment scope includes stocks, futures (index and commodity futures), and options, with a diverse strategy development team and a robust strategy library [2] - The company aims to explore and research quantitative investment strategies suitable for the characteristics of the Chinese capital market, integrating global leading financial institutions' experiences and technologies [2]

Core 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].