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].

在中位随访时间为61.4个月时，恩扎卢胺联合ADT治疗组的患者五年生存率为66%，而安慰剂联合ADT 组为53% 恩扎卢胺是目前首个且唯一在转移性激素敏感性前列腺癌患者中显示出五年总生存获益的雄激素受体抑 制剂 数据继续显示恩扎卢胺联合ADT治疗在不同患者亚组中具有广泛的治疗效果，特别是对于高肿瘤负 荷、既往未接受过多西他赛治疗以及同时性疾病的患者 长期数据进一步巩固了恩扎卢胺联合ADT作为标准治疗的地位 东京，2025年5月22日 —— 安斯泰来制药集团宣布了3期ARCHES(NCT02677896)研究的开放标签扩展 的长期随访结果，报告了在转移性激素敏感性前列腺癌(mHSPC)患者中，安可坦(恩扎卢胺)联合雄激素 剥夺疗法(ADT)与安慰剂联合ADT相比，总生存(OS)的五年随访数据，死亡风险降低了30%。这些数据 将在美国临床肿瘤学会(ASCO)年会上进行口头报告(摘要号#5005)，会议地点为芝加哥(美国中部时间6 月3日，上午9:45 - 下午12:45)。 "长久以来mHSPC前列腺癌患者的五年生存率一直较低，但随着以安可坦为代表的起始强化治疗方案的 进展，这类疗法正在成为标准治疗方案。"杜克癌 ...

Core Insights - The recent announcement of former US President Biden's prostate cancer diagnosis has brought attention to prostate cancer, the second most common malignancy among men globally [2] - The incidence and mortality rates of prostate cancer in China are rising, with 134,200 new cases and 47,500 deaths reported in 2022 [2] - The treatment landscape for prostate cancer is evolving, with numerous innovative pharmaceutical companies developing new therapies, enhancing treatment options for patients [2][4] Market Dynamics - The global prostate cancer treatment market was valued at $35.3 billion in 2022 and is projected to grow to $56.4 billion by 2028, with a compound annual growth rate (CAGR) of 8.3% [4] - Major pharmaceutical companies are competing in this lucrative market, with Pfizer and Astellas' enzalutamide generating $5.926 billion in global sales in 2023, ranking sixth among oncology drugs [3][4] - Chinese pharmaceutical companies are transitioning from generic to innovative drug development, with Heng Rui Medicine's new drug, Rivelutamide, set to launch in December 2024 [4] Treatment Advances - Treatment options for prostate cancer have expanded significantly, with survival rates improving from 2-3 years to over 5 years due to advancements in therapies such as new anti-androgens and PARP inhibitors [3] - The introduction of targeted therapies, such as Novartis' Pluvicto, which achieved $271 million in its first year, indicates a shift towards precision medicine in prostate cancer treatment [3][4] Screening Challenges - Early detection of prostate cancer remains a challenge, with many patients diagnosed at advanced stages due to the disease's asymptomatic nature in early stages [5][6] - The five-year survival rate for prostate cancer patients in China is approximately 66.4%, significantly lower than over 95% in developed countries, highlighting the need for improved screening practices [5] - PSA testing is the primary screening method, and initiatives are underway to increase screening coverage in China, aiming for 40% coverage in the next five years [7]

声明指出，拜登上周因泌尿系统症状加剧而新发现一个前列腺结节，医生在进一步评估后于16日诊断拜 登患有前列腺癌。 5月19日，央视新闻报道称，当地时间5月18日，根据美国前总统拜登办公室发布的一份声明，拜登被确 诊患有恶性前列腺癌，癌细胞已扩散至骨骼。 "虽然这是一种更具侵袭性的癌症，但这种癌症似乎对激素敏感，因此可以进行有效治疗。"声明称。现 年82岁的拜登及其家人"正在与他的医生共同探讨治疗方案"。 前列腺癌是全球男性第二大常见的肿瘤类型，大约有1/9的男性在一生中会被诊断为前列腺癌。 数据显示，前列腺癌是全球男性第二大常见的肿瘤类型，大约有1/9的男性在一生中会被诊断为前列腺 癌。 "前列腺癌相比其他恶性肿瘤而言，病情发展缓慢，病程较长，这也使得前列腺癌像糖尿病等慢病一 样，有更长的周期。"北京医院泌尿外科主任刘明教授表示。他进一步指出，早期前列腺癌病灶小，没 有特别的症状，等到发生血尿、尿潴留或转移性疼痛，往往就很晚了。 刘明补充道，我国有20%-30%的患者在初诊时已经发生转移，导致我国转移性前列腺癌五年生存率不到 50%。 但专家表示，即使是高危前列腺癌患者也可以过上相当正常的生活，并拥有良好的生活 ...

核心观点 25Q1 公司营业收入4.02 亿元，同比增加19.78%；归母净利润1.19 亿元，同比增加45.30%；扣非归母净 利润1.13 亿元，同比增加37.51%。 公司拟每10 股送现金2.90 元（含税），合计派发现金红利1.18 亿元。 简评 年度业绩符合预期，25Q1 略超预期，关注原料药产能释放 公司2024 年营收14.76 亿，同比+16.89%；归母净利润3.55 亿，同比+22.59%；扣非归母净利润3.51 亿，同比+34.25%。24Q4 单季度营收3.87 亿，同比+13.95%；归母净利润0.71 亿，同比+24.84%；扣非 归母净利润0.69 亿，同比+4.26%。25Q1 单季度营业收入4.02 亿元，同比增加19.78%，环比增加 3.76%；归母净利润1 .1 9亿元，同比增加45.30%，环比增加68.20%；扣非归母净利润1.13 亿元，同比增 加37.51%，环比增加62.8 2% 。 公司24 年营收及利润增长良好，业绩整体符合预期。25Q1 利润水平增长良好，业绩略超此前预期。原 料药保持稳健增长，心血管类、呼吸系统类及抗感染类表现良好。制剂业务放量， 积 ...