Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative performance increase of over 15% compared to the benchmark index within the next 6 to 12 months [23]. Core Insights - The company is transitioning from a biotech to a biopharma entity, with a focus on its first commercialized product, Aorebatinib, and the promising APG-2575, which is expected to partially replace and surpass Venetoclax in the large MDS and MM markets [4][21]. - APG-2575 is positioned as a potential "Best-in-Class" BCL-2 inhibitor, with unique clinical data supporting its convenient dosing regimen and improved safety profile compared to existing treatments [14][18]. - The company has a robust pipeline with multiple promising candidates, including APG-2449 and various apoptosis pathway inhibitors, which are expected to enhance its market position and growth potential [15][18]. Summary by Sections Financial Forecasts and Valuation - The company is projected to achieve revenues of 589 million, 1.509 billion, and 1.449 billion yuan for the years 2025 to 2027, with growth rates of -40%, 156%, and -4% respectively [4][21]. - The net profit attributable to the parent company is expected to be -681 million, 196 million, and 156 million yuan for the same period, indicating a significant turnaround [4][21]. - Earnings per share (EPS) are forecasted to improve from -1.83 yuan in 2025 to 0.42 yuan in 2027 [4][21]. Product and Market Insights - Aorebatinib's sales are expected to continue growing, with a 93% year-on-year increase to 217 million yuan in the first half of 2025, driven by effective hospital access and chronic disease management strategies [7][11]. - APG-2575 is anticipated to receive regulatory approval in mid-2025, further solidifying the company's leadership in the domestic hematological oncology market [11][12]. - The report highlights the potential of APG-2575 to achieve rapid relief and improved safety in treating high-risk myelodysplastic syndromes (HR MDS) compared to existing therapies [14][18]. Pipeline and Future Developments - The company has several promising candidates in its pipeline, including APG-2449, which is undergoing Phase III trials for ALK-positive NSCLC, and various apoptosis inhibitors that are expected to provide competitive advantages in the oncology market [15][18]. - Upcoming milestones include the completion of several Phase III clinical trials for key products, which are expected to enhance the company's market presence and revenue potential [20].

Core Insights - The Suzhou biopharmaceutical industry is experiencing a surge in innovation, with significant regulatory approvals and investments, positioning itself as a leader in the sector [1][2][4] Industry Developments - The approval of the world's first dual-target weight loss drug by Innovent Biologics and the simultaneous regulatory green light for Ascentage Pharma's innovative drug in the US and Europe highlight the rapid advancements in Suzhou's biopharmaceutical sector [1] - The establishment of the China (Jiangsu) Free Trade Zone Biopharmaceutical Industry Chain Open Innovation Development Plan is expected to further enhance the growth of the biopharmaceutical industry in Suzhou [1] Investment and Growth - As of July 2023, there are 261 foreign-funded biopharmaceutical enterprises in Suzhou, with a total output value exceeding 880 billion yuan, reflecting a year-on-year growth of 3.4% [2] - Roche Diagnostics has made a significant investment of approximately 480 million USD in Suzhou, marking its largest single investment in China, which underscores the importance of the Suzhou base for its global operations [2] Local Innovation - Suzhou has seen the addition of four new biopharmaceutical companies listed this year, bringing the total to 38, which is expected to exceed 40 by year-end [3] - A total of 64 companies are participating in the application for the seventh batch of national "specialized, refined, distinctive, and innovative" small giant enterprises, with expectations to surpass 100 by year-end [3] Product Innovation - From January to July 2023, Suzhou introduced six new Class I innovative drugs, accounting for 14% of the national total, and five new innovative medical devices, representing 10.6% of the national total [4] - The launch of Innovent Biologics' injection, a dual receptor agonist for weight loss, breaks the long-standing monopoly of multinational pharmaceutical companies in the GLP-1 weight loss market [5] Global Collaboration - Suzhou's biopharmaceutical companies are increasingly engaging in high-value overseas licensing agreements, with notable collaborations exceeding 10 billion USD [6] - The global registration of a Bcl-2 selective inhibitor by Ascentage Pharma, approved by both the FDA and EMA, signifies the international recognition of Suzhou's clinical trial standards [6] Technological Advancements - The successful use of a medical device developed by Suzhou's Peijia Medical in a complex surgery in Ethiopia exemplifies the global impact of Suzhou's innovative medical solutions [7] - The Suzhou government is actively drafting development plans for the biomanufacturing industry, aiming to enhance project attraction and support [8]

第 1 頁 共 10 頁 v 1.1.1 FF301 | 證券代號 (如上市) | 06855 | 說明 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | | 增加 / 減少 (-) | | | | 0 | | USD | | 0 | | 本月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年8月31日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 亞 ...

Investment Rating - The report assigns a "Buy-A" investment rating to the company, with a 6-month target price of 93.12 HKD [4][6]. Core Insights - The company reported a revenue of 234 million RMB and a net profit loss of 591 million RMB for the first half of 2025. The sales of Aorebatin continued to grow, with a 93% increase in revenue from 113 million RMB in the first half of 2024 to 217 million RMB in the first half of 2025 [2]. - The approval of Lisaftoclax in China is expected to provide a new revenue source, with multiple clinical trials progressing rapidly [3]. - The company anticipates revenues of 520 million RMB, 2.78 billion RMB, and 1.57 billion RMB for 2025, 2026, and 2027, respectively, with net profits projected at -1.04 billion RMB, 700 million RMB, and -520 million RMB for the same years [4]. Financial Performance Summary - Revenue for 2023 was 221.98 million RMB, projected to increase to 980.65 million RMB in 2024, and then to 519.81 million RMB in 2025, followed by 2.78 billion RMB in 2026 and 1.57 billion RMB in 2027 [9]. - The net profit for 2023 was -926.79 million RMB, expected to improve to -405.40 million RMB in 2024, and then to -1.04 billion RMB in 2025, with a forecasted profit of 696.27 million RMB in 2026 and a loss of 520.65 million RMB in 2027 [13]. - The company’s gross margin is expected to remain around 90% from 2025 to 2034, indicating strong profitability potential [10]. Clinical Development Pipeline - Aorebatin is undergoing multiple clinical trials, including the POLARIS-3, POLARIS-2, and POLARIS-1 studies, which are progressing smoothly [2]. - Lisaftoclax has received NMPA approval for treating adult CLL/SLL patients who have undergone prior treatment, with several global clinical trials also in progress [3].

Core Viewpoint - Yasheng Pharmaceutical has transformed from an undervalued entity to a highly sought-after player in the pharmaceutical sector within six months, with its stock price doubling and a significant increase in sales of its core product, Nairike, by over 90% [1] Financial Performance - In the first half of 2025, Yasheng Pharmaceutical reported total revenue of RMB 234 million, a year-on-year decline of 71.6%, primarily due to a high base from significant overseas licensing milestone payments in H1 2024 [2] - Excluding one-time revenues, Nairike's sales reached RMB 217 million, reflecting a 93% year-on-year growth, driven by the inclusion of all approved indications in the national medical insurance catalog [2] - As of June 30, 2025, the company's cash and bank deposits amounted to RMB 1.661 billion, a 31.7% increase, largely due to approximately RMB 970 million raised from its IPO in the U.S. [2] Core Product Driving Growth - Nairike, Yasheng's first commercialized product, is the first third-generation BCR-ABL inhibitor approved in China, targeting patients with TKI resistance and T315I mutations [3] - Since January 2025, all approved indications for Nairike have been included in the national medical insurance drug list, with an annual reimbursement standard of RMB 174,500, enhancing patient affordability and accessibility [3] - By June 30, 2025, Nairike's sales in China increased from RMB 113 million in the previous year to RMB 217 million, with the number of hospitals carrying the product rising by 47% [3] Dual-Engine Commercialization Strategy - On July 10, 2025, Yasheng's second core product, Lishengtuo, was approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma [4] - Lishengtuo is the first domestically approved original Bcl-2 inhibitor in China and the second globally, indicating significant market potential [4] Rapid Commercialization of Lishengtuo - Following its approval, Yasheng quickly signed cooperation agreements with major pharmaceutical distribution companies to advance its commercialization efforts [5] - Within 15 days, the product was prescribed in over 40 hospitals across more than 30 cities, demonstrating swift market entry [6] Global R&D Pipeline - Yasheng is accelerating the global clinical development of its pipeline, with nine Phase III clinical studies underway, three of which have received FDA approval [7] - The Bcl-2 inhibitor APG-2575 is considered a promising candidate, targeting high-value indications such as CLL, AML, and MM [7] - Nairike has three global Phase III studies in progress, with one receiving FDA approval for use in Ph+ALL patients [7] Commercialization Strategy: From Single Product to Multi-curve Layout - Yasheng employs a hybrid model of "self-sales + cooperative licensing" to mitigate risks, optimizing its domestic coverage while sharing market and registration costs with partners abroad [9] - The company is diversifying its pipeline with IAP inhibitors and MDM2 inhibitors, aiming to reduce reliance on single products [10] - In the blood cancer sector, Yasheng aims to replicate the success of AbbVie's Venetoclax, which achieved significant sales through continuous indication expansion [11] Conclusion - The rapid growth of Nairike demonstrates a viable path for Yasheng in the commercialization of original domestic drugs, but future growth will depend on the clinical and registration pace of subsequent pipelines like APG-2575 and the effectiveness of its international expansion strategy [12]

Core Insights - The company achieved a revenue of 234 million RMB in the first half of 2025, with sales of its core product, Nairike® (Orebatinib), reaching 217 million RMB, a year-on-year increase of 93% due to its inclusion in the national medical insurance catalog [1][3] - The company has a strong cash position with over 3 billion RMB in total cash, indicating improved cash flow [1][10] - The approval of the core product, Lishengtuo® (APG-2575), by the National Medical Products Administration (NMPA) in July 2025 marks a significant milestone, entering a dual-engine growth phase for the company [1][5] Product Development and Clinical Trials - Lishengtuo® has received global registration for a Phase III clinical trial for treating high-risk MDS patients, approved by both the FDA and EMA, which is a significant step in accelerating its market entry [2][8] - Nairike® has been recognized in updated clinical guidelines, enhancing its clinical value and potential, particularly in treating pediatric patients with Ph+ ALL [4][7] - The company is advancing multiple Phase III clinical trials globally, with nine ongoing studies, three of which have received FDA approval [7][10] Commercialization Strategy - The commercialization of Nairike® has accelerated, with a 90% quarter-on-quarter growth in sales, reflecting strong clinical demand and increased accessibility due to insurance coverage [3][10] - The company has established partnerships with major pharmaceutical distributors to enhance the commercialization of Lishengtuo®, achieving rapid prescription issuance across multiple cities and hospitals [5][10] - The successful launch of Lishengtuo® positions the company to maximize product synergies and strengthen its commercialization framework [5][10] Market Potential - Lishengtuo® is positioned to fill a significant market gap as the only Bcl-2 inhibitor advancing in the high-risk MDS space, with the potential to become the first approved treatment in this category globally [8][9] - The failure of a competitor's Bcl-2 inhibitor in clinical trials enhances Lishengtuo®'s market prospects, potentially leading to a dominant position in a multi-billion dollar market [9][10] - The company is exploring Lishengtuo®'s potential in various hematological malignancies, with ongoing global Phase III trials in multiple indications [10]

Core Viewpoint - The company's 1H25 performance aligns with expectations, showing significant revenue decline due to prior year licensing income, but new product approvals are expected to drive future growth [1][2]. Financial Performance - 1H25 revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to last year's licensing income [1]. - The net profit attributable to the parent company was a loss of 591 million yuan in 1H25 [1]. Development Trends - The entry of the new indication for Nairike into medical insurance has led to rapid growth in commercial revenue, with Nairike (Orebatin) generating 217 million yuan in 1H25, a year-on-year increase of 93% [1]. - The approval of Lisengsu (Lishazhuokela) for market launch is expected to contribute to new growth, being the first Bcl-2 inhibitor approved for CLL/SLL in China [1]. R&D Progress - The global Phase III clinical trial GLORA-4 for Lisengsu in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this area [2]. - Data from the 2025 ASCO indicated an overall response rate (ORR) of 75% for Lisengsu combined with Azacitidine in treating newly diagnosed MDS, highlighting a significant unmet need in this patient population [2]. Profit Forecast and Valuation - The company maintains its profit loss forecast for 2025 and 2026 at 1.09 billion HKD and 304 million HKD, respectively [2]. - The target price has been raised by 19.3% to 105 HKD, indicating a potential upside of 15.8% from the current stock price [2].

Core Viewpoint - CICC maintains the profit forecast for Ascentage Pharma-B (06855) for 2025 and 2026, reiterating an outperform rating, and raises the target price by 19.3% to HKD 105, indicating a 15.8% upside from the current stock price [1] Group 1 - The new indication for Olverembatin (耐立克) entering the medical insurance system has led to rapid growth in commercial revenue in the first half of the year, with a 93% year-on-year increase to CNY 217 million [2] - The approval of Lisavanbulin (利生妥) for marketing in China is expected to contribute to new growth, as it becomes the first Bcl-2 inhibitor approved for CLL/SLL patients who have received prior systemic therapy [2] - The global Phase III clinical trial GLORA-4 for Lisavanbulin in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this indication [3] Group 2 - Future research and development progress to monitor includes the FDA registration trial POLARIS-2 for Olverembatin, the registration trial for Ph+ALL, and the GLORA clinical trials for Lisavanbulin in CLL/SLL and MDS [4]

Core Viewpoint - CICC maintains the profit forecast for Ascentage Pharma-B (06855) for 2025/2026 and upgrades the target price by 19.3% to HKD 105, indicating a potential upside of 15.8% from the current stock price, driven by the progress of GLORA-4 and increased visibility in new indications [1] Group 1 - The commercial revenue of Nilotinib (Orelabrutinib) saw a significant increase of 93% year-on-year, reaching RMB 217 million in 1H25, attributed to its new indications being included in the medical insurance [2] - The approval of Lisavanbulin (Lisavan) for the treatment of CLL/SLL patients is expected to provide a new growth point for the company, as it becomes the first Bcl-2 inhibitor approved for CLL/SLL in China [2] Group 2 - The global Phase III registration trial GLORA-4 for Lisavanbulin in combination with Azacitidine has received approval from both the FDA and EMA, marking it as the only Bcl-2 inhibitor advancing in this indication [3] - The overall response rate (ORR) for Lisavanbulin combined with Azacitidine in treating newly diagnosed MDS patients reached 75%, indicating a strong safety profile and significant unmet needs in this patient population [3] Group 3 - Future research and development progress to monitor includes the FDA registration trial POLARIS-2 for Orelabrutinib, the registration trial progress for Ph+ ALL, and the GLORA and GLORA-4 studies for Lisavanbulin in the U.S. [4]

Core Viewpoint - The company is experiencing significant growth in its core product, Orebacitinib, despite a decline in overall revenue due to previous collaborations and licensing income. The commercial team is effectively expanding patient access and driving sales growth [1][2]. Group 1: Financial Performance - In H1 2025, the company's main operating revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to 678 million yuan in licensing income recorded in the same period of 2024 [1]. - The gross margin for H1 2025 was approximately 91% [1]. - Sales revenue from Orebacitinib increased significantly by 92.4% year-on-year to 217 million yuan [1]. - Sales expenses rose by 53.7% to 138 million yuan, while R&D expenses increased by 19% to 529 million yuan [1]. Group 2: Product Development and Commercialization - Orebacitinib's sales growth is expected to double by the end of the year, with a 93% increase in H1 2025 aligning with expectations [1]. - The company has expanded its commercial team, with a 47% increase in patient admissions in H1 2025, and all approved indications are now covered by insurance [1]. - The company is advancing multiple global clinical trials for Orebacitinib, including treatments for CML and Ph+ALL [1]. - On July 10, 2025, the company received conditional approval for Lisatoclax for CLL/SLL patients, with the first prescription already issued [2]. - The company has built its domestic commercialization team, which has grown to over 140 people as of July 31, 2025, and is expected to exceed 200 by the end of the year [2]. Group 3: Leadership and Cash Reserves - The company appointed Dr. Veet Misra as CFO and Mr. Huang Zhi as Senior Vice President of Global Corporate Development & Finance, enhancing leadership in global development [3]. - Cash reserves reached 1.661 billion yuan in H1 2025, and after a 1.5 billion yuan placement in Hong Kong, total cash reserves exceeded 3 billion yuan, sufficient to support ongoing core pipeline development [3]. Group 4: Revenue Forecast - The company anticipates rapid revenue growth driven by Orebacitinib and Lisatoclax sales, revising revenue forecasts for 2025-2027 to 586 million, 3.266 billion, and 2.121 billion yuan respectively [3].