Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatin (brand name: Nairik) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which received approval from both the FDA and EMA [1][2]. Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nairik approved by regulatory agencies in Europe and the US, which will expedite its market entry, particularly in Europe and the US [1]. - The POLARIS-1 study's latest progress will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the study data [2]. - Preliminary data from the study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate for patients treated with Nairik combined with low-intensity chemotherapy reached approximately 65%, significantly outperforming similar products under comparable conditions [2]. Group 2 - The treatment regimen demonstrated excellent safety profiles, with a low and manageable incidence of side effects, even for high-risk subtypes such as those carrying the IKZF1plus gene mutation [2].

Core Viewpoint - Ascentage Pharma-B (06855) has seen a stock price increase of over 6%, currently trading at 64.2 HKD, following the announcement of the global Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global Phase III trial for Nilotinib approved by major regulatory agencies in Europe and the U.S., which will expedite its market entry, particularly in Europe and the U.S. [1] - The study will present its latest findings at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the data [2] - Preliminary data indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response rate for patients treated with Nilotinib combined with low-intensity chemotherapy are around 65%, significantly outperforming similar products under comparable conditions [2] Group 2 - The treatment has shown promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, demonstrating good therapeutic outcomes [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of adverse effects [2]

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatinib (brand name: Nairike®) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - The POLARIS-1 study is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike® in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Study Results and Efficacy - Preliminary data from the POLARIS-1 study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate in patients treated with Nairike® and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under the same conditions [2]. - The treatment shows promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, and demonstrates excellent safety with low and manageable adverse effects [2]. Group 3: Market Position and Collaborations - 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 the company 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 [3]. - The company has signed an exclusive option agreement with Takeda for the global development and commercialization rights of Nairike®, excluding certain regions in Greater China [3].

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (POLARIS-1) for the novel drug Orebatin (brand name: Nairike) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which is expected to accelerate its market entry in Europe and the US [1][2]. Group 1: Clinical Trial Details - POLARIS-1 is an international, multicenter, randomized, open-label Phase III clinical trial aimed at evaluating the efficacy and safety of Nairike in combination with chemotherapy for newly diagnosed Ph+ ALL patients [1]. - The trial has received clinical trial approval from China's CDE in 2023 and has been rapidly initiated [1]. Group 2: Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nairike and low-intensity chemotherapy are approximately 65%, significantly higher than similar products under comparable conditions [2]. - The safety profile of the combination treatment is favorable, with a low and manageable incidence of adverse effects [2]. Group 3: Market Context and Product Background - Ph+ ALL accounts for about 20%-30% of adult ALL cases, characterized by high relapse rates and poor prognosis, particularly in older patients [2]. - Nairike is a third-generation TKI and the first of its kind approved in China, with commercial promotion in China being jointly managed by the company and Innovent Biologics [3]. - The drug has received multiple indications for treatment in the CML resistant field and is included in the national medical insurance drug list [3].

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， ...

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 | | | 致：香港交易及結算所有限公司 公司名稱: 亞盛醫藥集團 呈交日期: 2025年12月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 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 第 1 頁 共 10 頁 v 1.1.1 FF ...

Group 1 - The Hong Kong biotechnology sector experienced a widespread decline, with notable drops in several companies' stock prices [1] - Specifically, Gilead Sciences-B fell over 13%, while Sanofi-B dropped more than 10% [1] - Other companies such as Crystal Technology Holdings and Hualing Pharmaceutical-B also saw declines exceeding 6% [1] Group 2 - Gilead Sciences-B's latest price is 11.750, with a market capitalization of 116.56 billion and a year-to-date increase of 290.37% [2] - Sanofi-B's latest price is 7.000, with a market capitalization of 7.44 billion and a year-to-date increase of 102.31% [2] - Crystal Technology Holdings has a latest price of 9.330, a market capitalization of 401.48 billion, and a year-to-date increase of 56.02% [2] - Hualing Pharmaceutical-B's latest price is 3.230, with a market capitalization of 34.13 billion and a year-to-date increase of 121.23% [2] - Other companies like Wangshan Wangshui-B and Sanleaf Biotech-B also reported significant declines, with year-to-date increases of 123.25% and 920.75% respectively [2]

Core Viewpoint - As of the announcement date, the company has granted a total of 1,304,500 restricted stock units (RSUs) to 146 selected individuals under the 2022 Restricted Stock Unit Plan, which corresponds to 1,304,500 shares [1] Summary by Categories Restricted Stock Units - The company has awarded 1,304,500 RSUs to 146 selected individuals under the 2022 plan, with further grants expected in 2022 [1] Stock Options - The company has granted a total of 736,600 stock options to 34 recipients under the post-initial public offering stock option plan, which allows for the subscription of an equivalent number of ordinary shares, pending acceptance by the option recipients [1]

Core Viewpoint - As of the announcement date, the company has granted a total of 1,304,500 restricted stock units to 146 selected individuals under the 2022 Restricted Stock Unit Plan, which corresponds to 1,304,500 shares [1] Group 1 - The company has also granted a total of 736,600 stock options to 34 grantees under the post-IPO stock option plan, which can be exercised to subscribe for a total of 736,600 ordinary shares of the company, pending acceptance by the option grantees [1]