Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy in first-line treatment of gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of the III phase clinical study of Nilotinib in first-line treatment of Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharma-B (02595) initiated a registration clinical trial for GFH375 in metastatic pancreatic cancer, marking the first global oral KRAS G12D inhibitor monotherapy controlled chemotherapy III phase study [1] - Xixiangfeng Group (02473) subsidiary signed a business cooperation agreement with Hello Car Rental to develop car rental business in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for GLP-1/GIP receptor dual agonist peptide injection [1] - MIRXES-B (02629) plans to collaborate with Jingtai Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automotive (01728) plans to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) intends to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) announced that seven innovative products, including new indications, were successfully included in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biopharma-B (09887) clinical data for LBL-034 was presented at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Aurantium Extract Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) had five new products successfully included in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) core products were included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported contract sales of approximately 47.7 billion yuan in the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported November equity power generation of 697.23 GWh, a year-on-year increase of 7.77% [2]

Core Insights - The company Ayshun Pharmaceutical-B (06855) has received approval from the FDA and EMA to conduct the global Phase III clinical trial (POLARIS-1) for its novel drug Orebatinib (brand name: Nairike®) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients [1][2] - The POLARIS-1 study is an international, multicenter, randomized, open-label Phase III trial aimed at evaluating the efficacy and safety of Nairike® combined with chemotherapy in Ph+ ALL patients [1] - Preliminary data from the POLARIS-1 study indicates a molecular minimal residual disease (MRD) negative rate and complete response (CR) rate of approximately 65% in newly diagnosed Ph+ ALL patients treated with Nairike® and low-intensity chemotherapy, showing significant improvement compared to similar products [2] Company Developments - Nairike® is a first-in-class oral third-generation TKI and the first third-generation BCR-ABL inhibitor approved in China, with commercialization in China managed by Ayshun Pharmaceutical and Innovent Biologics [3] - The drug has received multiple indications for treatment in CML resistance areas and is included in the national medical insurance drug list in China [3] - Ayshun Pharmaceutical signed an exclusive option agreement with Takeda regarding Orebatinib, granting Takeda global development and commercialization rights, excluding certain regions in Greater China [3]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的全部內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立的有限公司） （股份代號：6855） ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 自願公告 亞盛醫藥耐立克®一線治療Ph+ ALL的全球註冊III期 臨床研究獲美國FDA和歐洲EMA批准 2024年6月14日，亞盛醫藥與跨國製藥企業武田就奧雷巴替尼簽署了一項獨家選 擇權事宜。一旦行使選擇權，武田將獲得開發及商業化耐立克®的全球權利許可， 惟中國大陸、中國香港特別行政區、中國澳門特別行政區、中國台灣等地區除外。 承董事會命 亞盛醫藥集團 主席兼執行董事 楊大俊博士 值得一提的是，POLARIS-1研究的最新進展也將在即將召開的2025年美國血液 學會（American Society of Hematology，ASH）年會上亮相，這是該研究數據的首 次公佈。目前已披露的摘要數據顯示：在耐立克®聯合低強度化療治療的初治Ph+ ALL患者中， ...

Core Insights - The company has announced multiple clinical and preclinical advancements for three products (Nailike®, Lishengtuo®, APG-5918) selected for presentation at the 67th American Society of Hematology (ASH) Annual Meeting, with one receiving an oral presentation [1] - The company's original first-in-class drug, Orebatinib (Nailike®), has been selected for the ASH meeting for the eighth consecutive year, highlighting its ongoing clinical progress [1] - The original first-in-class drug, Lishatoclax (Lishengtuo®; R&D code: APG-2575), has two clinical advancements selected for the ASH meeting, marking its fourth consecutive year of selection [1] Product Developments - Nailike® is the first third-generation BCR-ABL inhibitor approved in China, with commercialization jointly managed by the company and Innovent Biologics. The company will present the latest data from the global Phase III POLARIS-1 study on Nailike® combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients at the ASH meeting [2] - The company will also update data from a randomized controlled Phase II study on Nailike® for patients with tyrosine kinase inhibitor (TKI) resistant chronic myeloid leukemia in chronic phase (CML-CP) and data for second-line treatment of non-T315I mutation CML-CP patients [2] - Lishatoclax is a novel oral Bcl-2 selective inhibitor developed by the company, approved in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor. The company will present the latest advancements from a registered Phase II clinical study on Lishatoclax for relapsed/refractory (R/R) CLL/SLL patients [2] Event Information - The 67th ASH Annual Meeting is one of the largest international academic events in the field of hematology, covering research on the etiology and treatment of blood diseases. The event will take place from December 6 to December 9, 2025, in Orlando, Florida, in a hybrid format [3]

Core Insights - The company, Ascentage Pharma-B (06855), announced multiple clinical and preclinical advancements for three products (Orebactin®, Lisatoclax®, APG-5918) selected for presentation at the 67th American Society of Hematology (ASH) Annual Meeting, including one oral presentation [1] - Orebactin® has been selected for ASH for eight consecutive years, showcasing its ongoing clinical progress [1] - Lisatoclax® has two clinical advancements selected for ASH, marking its fourth consecutive year of inclusion [1] Group 1: Product Developments - Orebactin® is the first approved third-generation BCR-ABL inhibitor in China, with commercialization jointly managed by Ascentage Pharma and Innovent Biologics [2] - At the ASH meeting, the company will present the latest data from the global Phase III POLARIS-1 study on Orebactin® combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [2] - The company will also update data from a randomized controlled Phase II study on Orebactin® for TKI-resistant chronic myeloid leukemia in chronic phase (CML-CP) patients, including four-year follow-up data [2] Group 2: Lisatoclax® Insights - Lisatoclax® is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, showing potential in treating various hematological malignancies and solid tumors [2] - The product has been approved in China for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment, including a Bruton tyrosine kinase (BTK) inhibitor [2] - The company will present the latest advancements from a registered Phase II clinical study of Lisatoclax® as a monotherapy for relapsed/refractory CLL/SLL patients, along with data on its combination with azacitidine for newly diagnosed or previously venetoclax-treated myeloid tumor patients [2] Group 3: ASH Annual Meeting - The ASH Annual Meeting is one of the largest international academic events in the field of hematology, covering research on the etiology and treatment of blood diseases [3] - The 67th ASH Annual Meeting will take place from December 6 to December 9, 2025, in Orlando, Florida, in a hybrid format [3]

Core Insights - The company achieved significant milestones in product commercialization, clinical development, and international expansion under its "Global Innovation" strategy, reporting a revenue of 234 million RMB for the first half of 2025, with sales of Nairike® reaching 217 million RMB, a 93% year-on-year increase due to its inclusion in the medical insurance coverage for all approved indications [1][2] Financial Performance - The company reported a total revenue of 234 million RMB for the reporting period, with Nairike® sales contributing 217 million RMB, reflecting a 93% increase year-on-year [1] - The company has over 3 billion RMB in cash and cash equivalents, indicating improved cash flow [2] Product Development - Nairike® is currently involved in three global Phase III clinical trials, with one trial approved by the FDA, targeting Chronic Myeloid Leukemia (CML), Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), and SDH-deficient Gastrointestinal Stromal Tumors (GIST) [2] - The company is advancing its other key product, Lisengtuo®, which received NMPA approval in July 2025, marking it as China's first domestically approved Bcl-2 inhibitor [3] Strategic Initiatives - The launch of Lisengtuo® signifies the company's entry into a dual-engine growth phase, with plans to enhance its commercialization system to maximize product synergy [3] - The company is exploring Lisengtuo®'s potential in treating CLL/SLL, AML, MDS, and multiple myeloma (MM), with four global Phase III clinical trials currently underway, two of which have received FDA approval [3]

Core Viewpoint - The approval of the novel Bcl-2 inhibitor, Lisatoclax (APG-2575), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, as it becomes the first domestically developed Bcl-2 inhibitor approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China and the second globally [1][2]. Group 1: Product Approval and Significance - Lisatoclax is the first Bcl-2 inhibitor approved in China for CLL/SLL, highlighting its potential in the treatment landscape [2][3]. - The drug is expected to restore normal apoptosis in tumor cells by selectively inhibiting the Bcl-2 protein, offering new treatment options for patients [2][3]. - The approval signifies Ascentage Pharma's commitment to global clinical innovation and represents a key milestone in its journey to enter the global market [2]. Group 2: Clinical Research and Development - Ascentage Pharma is conducting four global Phase III clinical trials for Lisatoclax, targeting various patient groups, including those with previously treated CLL/SLL and newly diagnosed acute myeloid leukemia (AML) [2]. - The ongoing studies include the GLORA study for treated CLL/SLL patients and GLORA-2 for treatment-naive CLL/SLL patients, among others [2]. Group 3: Challenges in Bcl-2 Inhibition - The development of Bcl-2 inhibitors has been challenging due to the complex nature of protein-protein interactions and the need for drugs to penetrate cellular membranes and mitochondrial membranes [3]. - Prior to Lisatoclax, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in addressing this treatment gap [3].

Core Viewpoint - In 2024, the Hong Kong pharmaceutical sector experienced significant declines due to external factors, with the Hang Seng Healthcare Index down 18.93% and the Hong Kong Innovative Drug Index down 10.80%. However, Ascentage Pharma-B (06855) saw a remarkable stock price increase of 66.48%, outperforming the indices due to multiple unexpected positive developments in product internationalization, innovative research, and secondary market financing, validating the company's "investment certainty" [1]. Financial Performance - Ascentage Pharma reported a revenue of RMB 981 million in 2024, a substantial increase of 342% year-on-year. The sales revenue of the core product, Nairik (耐立克®), reached RMB 241 million, reflecting a growth of approximately 53%. The company's cash flow improved, with a monetary fund balance of RMB 1.261 billion as of December 31, 2024, up 15.3% year-on-year [2]. Product Development and Market Potential - Nairik has successfully passed the 2024 National Medical Insurance negotiation process and will be included in the new National Medical Insurance Drug List starting January 1, 2025. This inclusion indicates strong recognition of the drug's innovative capabilities by the domestic medical system, which typically leads to rapid sales growth for innovative drugs post-inclusion [2]. - Ascentage Pharma signed a $1.3 billion exclusive option agreement with Takeda Pharmaceutical for Nairik, setting a new record for domestic small molecule oncology drug business development transactions [3]. Clinical Advancements - Nairik is positioned to become the first TKI drug approved for first-line treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in China, with significant market potential. The drug has been included in the "Breakthrough Therapy Designation" list and is expected to generate considerable sales growth in the Ph+ ALL treatment market [4][5]. - In the solid tumor field, Nairik's Phase III clinical trial for treating SDH-deficient GIST patients has received approval, and the drug has shown excellent anti-tumor effects in various clinical presentations [4]. Research and Development - Ascentage Pharma's R&D investment reached RMB 947 million in 2024, supporting strong revenue growth and cash flow expectations. The company is conducting ten registration clinical trials, with two receiving FDA approval, laying a solid foundation for exploring the global differentiated innovative drug market [5]. - The company has two core products, Nairik and APG-2575, both with billion-dollar potential, alongside several other promising candidates in development. Ascentage holds 541 global patents, with 379 granted overseas, establishing a robust global intellectual property framework [5]. Market Position and Future Outlook - APG-2575, a Bcl-2 inhibitor, has been accepted for priority review by the NMPA for treating refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). It is expected to become the second Bcl-2 inhibitor approved globally, with projected sales exceeding $2 billion [6][7]. - Ascentage Pharma successfully listed on the US stock market in 2024, raising approximately $126 million, enhancing its international financing channels. The company is well-positioned as a high-value biopharmaceutical investment in the US market [7]. Conclusion - With strong cash flow and an integrated innovation loop, Ascentage Pharma is accelerating its transition to a leading global biopharma through systematic competition in global R&D, overseas registration, and international commercialization [8].