7 月10 日，公司公告自主研发的新型Bcl-2 选择性抑制剂利生妥（利沙托克拉，APG-2575）获中国国家 药品监督管理局附条件批准上市，用于既往经过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一种 系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者。 机构：中金公司 研究员：张琎/刘雅馨/朱言音 公司近况 盈利预测与估值 我们维持2025 年/2026 年归母净利润预测亏损10.9 亿元/亏损3.2 亿元不变。考虑到利生妥获批上市及全 球适应症拓展前景，我们维持跑赢行业评级，根据DCF模型，上调目标价27.5%至88 港币，较当前股价 有15.3%的上行空间。 风险 研发失败，审评进展不及预期，竞争格局恶化，对外合作不及预期。 评论 利生妥成为中国首个上市用于治疗CLL/SLL的Bcl-2 抑制剂，也是全球第二个上市的Bcl-2 抑制剂。Bcl- 2 靶点成药性难度较大，难以设计小分子去抑制其蛋白-蛋白相互作用机制。根据公司公告，此前，中 国尚未有Bcl-2 抑制剂获批用于治疗CLL/SLL，全球也仅艾伯维的维奈克拉获批上市。我们认为利生妥 的获批上市有望为国内CLL/SLL后线 ...

证券研究报告·海外公司点评·药品及生物科技(HS) 亚盛医药-B（06855.HK） APG-2575 国内获批，首款国产 Bcl-2 上市 2025 年 07 月 11 日 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 225.09 | 980.65 | 519.00 | 3,215.00 | 2,095.00 | | 同比(%) | 6.24 | 335.68 | (47.08) | 519.46 | (34.84) | | 归母净利润（百万元） | (925.64) | (405.43) | (726.53) | 1,097.79 | (841.66) | | 同比(%) | (4.84) | 56.20 | (79.20) | 251.10 | (176.67) | | EPS-最新摊薄（元/股） | (2.66) | (1.16) | (2.08) | 3.15 | (2.42) | | P/E（现价 ...

Core Insights - The clinical data for Aosheng Pharmaceutical's core product, Orebatinib, presented at the EHA annual meeting indicates its potential to improve long-term outcomes for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) through various combination therapies [1] - Aosheng Pharmaceutical's APG-2575 showed promising results in treating myeloid malignancies, enhancing its commercial prospects against competitors like Venetoclax [2] - The company is expected to experience rapid revenue growth due to the sales ramp-up of Orebatinib and potential payments from Takeda, with revenue forecasts for 2025-2027 indicating significant increases [3] Group 1: Orebatinib Clinical Data - Orebatinib combined with Belinostat in a single-arm clinical trial for Ph+ or Ph-like ALL showed a median follow-up of 17 months, with a complete response (CR) rate of 100% after one treatment cycle and an overall survival (OS) rate of 100% at 18 months [1] - In the Orebatinib combined with VP regimen for adult Ph+ ALL, the overall response rate (ORR) was 100%, with a CR rate of 97.3% and a 2-year OS rate of 96.3% [1] Group 2: APG-2575 Clinical Data - The ASCO annual meeting revealed that APG-2575 combined with Azacitidine in a clinical study for previously treated or untreated myeloid malignancies had an ORR of 31.8%, with 4.6% of patients achieving a partial response (PR) [2] - The data suggests that APG-2575 may have a competitive edge over Venetoclax, particularly in differentiated indications, and the company is also exploring potential markets in MDS and MM [2] Group 3: Revenue Forecast and Investment Outlook - The company anticipates rapid revenue growth, maintaining revenue forecasts of 519 million yuan and 3.215 billion yuan for 2025 and 2026, respectively, with an additional forecast of 2.095 billion yuan for 2027 [3] - The strong growth outlook is supported by the overseas market potential and the expected sales increase of Orebatinib, leading to a "buy" rating for the stock [3]

Summary of the Conference Call for Ascentage Pharma Company Overview - **Company**: Ascentage Pharma - **Focus**: Development of innovative anti-cancer therapies, particularly BCL-2 selective inhibitors and MDM2-P53 pathway inhibitors Key Points Industry and Product Highlights - **APG2,575**: A selective BCL-2 inhibitor showing significant efficacy in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) - Overall Response Rate (ORR) in treatment-naive patients is 83% and 43% in relapsed/refractory patients - ORR of 31% in patients previously treated with Venetoclax, indicating potential for hard-to-treat cases [2][4] - Faster onset of action (Tmax of 3-8 hours vs. 25-30 hours for Venetoclax) and shorter half-life (3-5 hours vs. 25-30 hours) [2][6] - Lower incidence of tumor lysis syndrome compared to Venetoclax [6] - **APG115**: An MDM2-P53 pathway inhibitor with potential applications across various cancer types - Clinical data presented at ASCO showed promising results, particularly in neuroendocrine tumors (ACC) [2][7][11] - In a Phase II trial, 2 complete responses and significant disease stabilization were observed [11] Clinical Development Plans - Ascentage Pharma plans to continue advancing APG2,575 and APG115 through global clinical trials, including registration studies for high-risk MDS and treatment-naive AML patients [4][12] - Ongoing discussions with regulatory bodies regarding the next steps for APG115 registration studies [12] Competitive Landscape - Venetoclax has shown lower infection rates and better tolerability in nearly 100 AML and MDS patients, establishing it as a standard treatment [10] - Ascentage Pharma is positioned as the second company globally to enter BCL-2 inhibitor clinical trials, with IND approval obtained [16] Future Directions - The company aims to strengthen collaborations with leading research institutions and companies to accelerate the development of new anti-cancer therapies [9][25] - Focus on expanding clinical trials and exploring combination therapies to address unmet medical needs in oncology [25] Market Potential - The market for multiple myeloma is substantial, with sales exceeding $30 billion in 2024, and Ascentage's BCL-2 inhibitors are expected to play a significant role [23][24] - The company is exploring registration clinical plans for multiple myeloma based on promising safety and efficacy data [24] Additional Insights - The company is actively pursuing global registration studies and expanding patient enrollment in ongoing trials [15][21] - Emphasis on the importance of safety and tolerability in the development of BCL-2 inhibitors, especially in comparison to existing therapies [18][24] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting Ascentage Pharma's commitment to advancing innovative cancer therapies and addressing significant market opportunities.

证券研究报告 | 行业周报 2025 年 05 月 06 日 医药 本周医药板块上涨 0.49%，百济神州 BCL-2 抑制剂申报上市 | 股票 | 股票 | 投资 | EPS（元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 93.95 | 67.11 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 13.13 | 11.22 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | -43.54 | -723.88 | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.53 | 22.68 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 3 ...