2025 年 08 月 27 日 亚盛医药-B(06855.HK) 奥雷巴替尼持续放量，Lisaftoclax 国 内获批成为新增量 事件：公司发布 2025 年中期业绩，报告期内公司实现营业收入 2.34 亿元，实现归母净利润-5.91 亿元。 奥雷巴替尼持续放量，多个临床快速推进中。销售放量方面， 2025 年上半年奥雷巴替尼在中国的销售收入增长 93%，从 2024 年 上半年的 1.13 亿元人民币增至 2.17 亿元人民币，放量趋势明显。 临床开发方面，治疗既往系统性治疗失败的琥珀酸脱氢酶（SDH） 缺陷型胃肠间质瘤（GIST）患者的注册 III 期临床 POLARIS-3 研 究、治疗伴有或不伴有 T315I 突变的经治 CML-CP 成年患者的注 册 III 期临床 POLARIS-2 研究、联合化疗对比伊马替尼联合化疗 治疗新诊断费城染色体阳性（Ph+）急性淋巴细胞白血病（ALL） 患者的注册 III 期临床 POLARIS-1 研究正顺利推进中，且公司正 计划争取 FDA 许可以开展一项针对新诊断 Ph+ ALL 患者的注册 III 期临床研究。 Bcl-2 抑制剂 Lisaftoclax ...

机构：东吴证券 利沙托克拉上市获批，商业化进展顺利：25 年7 月10 日利沙托克拉获CDE 附条件批准上市，用于既往 经过至少包含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。从24 年11 月申请上市到获批仅用时约7 个月，目前已经开出第一份处方。该管线 还有多项全球临床推进中，包括1L 和2L 的CLL/SLL注册临床、联合AZA 治疗AML。公司8 月18 日公 布其MDS 全球注册临床获得FDA 和EMA 批准，利沙托克拉的主要竞争对手维奈克拉此前在该适应症 上失败，因此如果成功上市有望未来贡献较大增量。 商业化能力不断提升，在手现金足以支撑管线研发：公司在奥雷巴替尼销售中采取了和信达生物合作开 发的模式，借此搭建了自己的国内商业化运营团队，截至25 年7 月31 日超过140 人。而此次利沙托克拉 的商业化工作则全部由公司自行开展，我们预计到25 年底或将超过200 人。 25 年7 月公司宣布任命Veet Misra 博士为首席财务官，并任命黄智先生为全球企业发展&财务高级副总 裁，二人都具备丰富的国际商业化经验，公司全球发展团队领导力大幅提 ...

Investment Rating - The report maintains an "Outperform" rating for Ascentage Pharma with a target price of HKD 90.70, reflecting a potential upside from the current price of HKD 90.20 [2][24]. Core Insights - Ascentage Pharma reported strong product sales growth, with revenue from product sales reaching RMB 213 million, a 70.5% increase year-on-year, driven by a 93% increase in sales of Olverembatinib [3][15][17]. - The company achieved a gross profit of RMB 212 million with a gross margin of 90.7%, indicating improved operational efficiency [3][15]. - R&D expenses increased by 19% year-on-year to RMB 529 million, reflecting ongoing global clinical trials and the company's commitment to advancing its pipeline [3][18]. Financial Performance - For the first half of 2025, total revenue was RMB 234 million, down 71.6% year-on-year, primarily due to a one-off intellectual property income from Takeda in the previous year [3][15]. - The company recorded a net loss of RMB 591 million during the same period, with cash reserves totaling approximately RMB 3.15 billion [3][15][18]. - The report projects revenues for FY25, FY26, and FY27 to be RMB 730 million, RMB 3.16 billion, and RMB 3.02 billion, respectively, with corresponding net profits of RMB -1.09 billion, RMB 1.39 billion, and RMB 990 million [9][21]. R&D Progress - The approval of Lisaftoclax® for treating CLL/SLL patients was a significant milestone, and the initiation of the GLORA-4 Phase III trial for higher-risk MDS patients is expected to accelerate the drug's market entry [4][16][20]. - Efficacy data presented at the 2025 ASCO meeting showed promising results for Lisaftoclax® in MDS and CMML patients, with an overall response rate of 80% in newly diagnosed patients [20][21]. Market Dynamics - The report highlights the significant unmet medical need in the MDS treatment landscape, particularly for higher-risk patients, where current therapies have limited efficacy [19][20]. - The combination of National Reimbursement Drug List coverage and expanded hospital access has driven sales growth for Olverembatinib, with a 114% increase in sales volume [17][18].

2025 年中报点评：药品商业化符合预期，临 床推进潜力倍增 证券研究报告·海外公司点评·药品及生物科技(HS) 买入（维持） 亚盛医药-B（06855.HK） | [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 | 585.73 | 3,265.89 | 2,121.05 | | 同比(%) | 6.24 | 335.68 | (40.27) | 457.58 | (35.05) | | 归母净利润（百万元） | (925.64) | (405.43) | (874.02) | 1,058.67 | (893.33) | | 同比(%) | (4.84) | 56.20 | (115.58) | 221.13 | (184.38) | | EPS-最新摊薄（元/股） | (2.49) | (1.09) | (2.35) | 2.85 | (2.40) | | P/E（现价&最新摊薄） | (33. ...

中国银河（601881）证券发布研报称，血液肿瘤分类复杂，多种细分亚型治疗领域仍存在较多投资机 会。近年来在靶向、免疫以及细胞治疗等新兴治疗手段的推广应用下，血液瘤治疗已呈现与高血压、糖 尿病类似的慢病管理趋势。血液瘤的长生存周期带来大量存量患者，且药物治疗费用高，导致重磅产品 频出，潜在市场机会巨大。建议关注百济神州(06160)、诺诚健华(09969)、亚盛医药-B(06855)、迪哲医 药-U(688192.SH)。 AML、ALL等急性白血病目前主要采用化疗或靶向联合化疗模式，并通过靶向治疗和多药联合提升生 存率。在慢性白血病治疗中，CML主要采用BCR-ABLTKI治疗，尝试通过技术迭代及新靶点克服耐 药;CLL治疗包括BTK、BCL-2、CD20等药物，正探索BTK+BCL-2固定疗程给药及开发非共价BTK、双 靶BTK、BTKPROTAC等布局BTK耐药后市场。淋巴瘤亚型较多，大多数采用利妥昔联合化疗，而多发 性骨髓瘤仍以CD38单抗治疗为核心;淋巴瘤中侵袭性较强的DLBCL和多发性骨髓瘤均面临复发概率高且 复发后难治的问题，目前CAR-T疗法缓解率较高，为后线患者提供更多治疗选择。 靶向药竞争 ...

Summary of Ascentage Pharma's Conference Call Company Overview - **Company**: Ascentage Pharma - **Key Products**: Lisatoclax (2,575) and Olverembatinib (Aurebatinib) Industry Insights - **Market Focus**: Hematological malignancies, specifically targeting CLL (Chronic Lymphocytic Leukemia), MDS (Myelodysplastic Syndromes), and MM (Multiple Myeloma) [2][6] - **Competitive Landscape**: The market for BCL-2 inhibitors is competitive, with Lisatoclax being the second BCL-2 inhibitor globally approved, following Venetoclax [19] Core Points and Arguments - **Lisatoclax Development**: - Submitted for CLL indication in China and plans to expand into MDS and MM, which have less competition [2][6] - Expected to leverage safety advantages to capture market share [2] - Clinical trial data presented at ASCO 2025 showed an ORR of 83.3% in AML patients and 43% in difficult-to-treat AML patients [23] - **Olverembatinib Performance**: - Achieved sales of 241 million RMB in 2024, with expectations to double in 2025 [3] - Positioned as a third-generation TKI targeting T315I resistant patients, showing significant safety advantages over competitors [11][15] - **Collaboration with Takeda**: - A $1.3 billion licensing agreement was reached, with Takeda expected to exercise options post-2026 [5] - This partnership indicates recognition of Chinese-developed drugs by international firms [5] - **Research and Development Focus**: - Future R&D investments will prioritize overseas registration and domestic indication expansions for Lisatoclax [4] - Cash flow is projected to support these initiatives [4] Additional Important Insights - **Market Potential**: - Lisatoclax's peak sales potential is estimated between $3 billion to $4 billion globally [19] - Olverembatinib's peak sales in overseas markets could reach $2 billion to $3 billion, with domestic sales expected to approach 2 billion RMB [18] - **Competitive Advantages**: - Lisatoclax offers better safety and faster dose escalation compared to Venetoclax, enhancing patient compliance [19] - The strategic approach of entering the market with a cautious clinical trial design allows for quicker market capture [22] - **Management and Shareholder Structure**: - Led by Dr. Yang Dajun, with a strong management team experienced in drug development [7] - Takeda is a significant shareholder, reflecting confidence in Ascentage's capabilities [8] - **Future Outlook**: - Plans to expand into ALL (Acute Lymphoblastic Leukemia) with Philadelphia chromosome-positive patients, which could significantly boost sales [14] - The company is also exploring new product pipelines targeting solid tumors and hematological malignancies [9] This summary encapsulates the key insights from Ascentage Pharma's conference call, highlighting the company's strategic direction, product performance, and market opportunities.

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has received conditional approval from the National Medical Products Administration (NMPA) for its self-developed Bcl-2 selective inhibitor APG-2575, marking it as the first domestically produced Bcl-2 inhibitor to be launched in China [7] - APG-2575 is positioned as a new treatment option for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, including BTK inhibitors [7] - The company expects rapid revenue growth driven by the sales of its drug Aolebatin and potential payments from Takeda, with projected revenues of 5.19 billion, 32.15 billion, and 20.95 billion yuan for 2025, 2026, and 2027 respectively [1][7] Financial Projections - Total revenue is projected to reach 980.65 million yuan in 2024, followed by 519 million yuan in 2025, and then a significant increase to 3,215 million yuan in 2026, before declining to 2,095 million yuan in 2027 [1][8] - The net profit attributable to the parent company is expected to be (405.43) million yuan in 2024, (726.53) million yuan in 2025, 1,097.79 million yuan in 2026, and (841.66) million yuan in 2027 [1][8] - The earnings per share (EPS) are forecasted to be (1.16) yuan in 2024, (2.08) yuan in 2025, 3.15 yuan in 2026, and (2.42) yuan in 2027 [1][8]

Company Overview - InnoCare aims to become a global biopharmaceutical leader, focusing on oncology and autoimmune diseases[6, 7, 8] - The company has raised a total of $134 billion USD since its founding in 2015[11] - InnoCare has a fully-integrated drug innovation platform with 13 clinical products in the pipeline and 2 marketed products[13] Orelabrutinib (BTKi) - Orelabrutinib demonstrates ~100% BTK occupation at 50 mg QD and above, with an improved safety profile[23] - Orelabrutinib has shown an 83% overall response rate (ORR) in r/r MCL patients and a 589% ORR in r/r MZL patients[34] - A Phase III registrational trial for Orelabrutinib is ongoing in China for SLE[52] ICP-332 (TYK2 Inhibitor) - ICP-332, at 80mg QD, achieved a 782% reduction from baseline in EASI score in Atopic Dermatitis (AD) patients[75] - 88% of patients achieved EASI 50 and 72% achieved EASI 75 at Week 4 with ICP-332 treatment[75] - Global AD market is expected to reach $222 billion USD by 2028[71] Portfolio Expansion - Tafasitamab BLA submission in China is planned for 2024Q2, targeting 160,000 new DLBCL patients globally per annum[46] - ICP-248 (BCL-2 inhibitor) showed 100% efficacy (6 out of 6 patients) in early clinical results[41] - InnoCare plans to submit an NDA for 1L CLL/SLL in China and r/r MCL in the USA for Orelabrutinib in the second half of 2024[102]

Macro Strategy - The Federal Reserve did not lower interest rates in June and removed the judgment of higher unemployment and inflation from its statement, indicating a more stagflationary economic outlook [1][11] - The Fed revised down the US GDP growth forecast for Q4 2025 from 1.7% to 1.4% and raised the unemployment rate forecast from 4.4% to 4.5% [11] - The PCE inflation forecast for Q4 2025 was increased from 2.7% to 3.0%, with core PCE rising from 2.8% to 3.1% [11] Industry Analysis - In April 2025, the domestic installed capacity of new energy increased by 214.7%, with 45.22 GW added, marking the highest monthly increase for solar power in the first half of the year [5][17] - The global solar market is expected to grow, with a forecasted 10% increase in new installations in 2025 under neutral conditions, and up to 30% under optimistic scenarios [17] - The wind power sector is experiencing growth, with a 20% increase in land wind turbine bidding in the first five months of 2025 [17] Company Recommendations - BaiRun Co., Ltd. is expected to achieve revenues of 3.5 billion, 4 billion, and 4.7 billion yuan from 2025 to 2027, with net profits of 810 million, 970 million, and 1.18 billion yuan respectively, maintaining a "buy" rating [6][19] - YaSheng Pharmaceutical is projected to see rapid revenue growth, with forecasts of 519 million yuan and 3.215 billion yuan for 2025 and 2026, respectively, also maintaining a "buy" rating [7] - Top Cloud Agriculture is expected to benefit from the development of smart agriculture, with projected revenues of 659 million, 875 million, and 1.136 billion yuan from 2025 to 2027, receiving a "buy" rating [8]

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]