Investment Rating - The report maintains an investment rating of "Outperform" with a target of A [7] Core Insights - The report highlights the positive results from Takeda's new generation oral TYK2 inhibitor, zasocitinib (TAK-279), for treating moderate to severe plaque psoriasis, with over 50% of participants achieving skin clearance or nearly clear skin (PASI 90) at week 16, and about 30% achieving complete clearance (PASI 100) [3][4] - The report suggests that there are multiple catalysts expected in the sector, including academic conferences and data readouts, which could provide investment opportunities [2] - The report emphasizes the potential of other TYK2 inhibitors, particularly Eifang Biopharma's D-2570, which has shown promising phase 2 clinical data [4][22] Summary by Sections Weekly New Drug Market Review - From December 15 to December 21, 2025, the top five gainers in the new drug sector were: Yahu Medicine (+12.03%), Cloudtop New Medicine (+9.32%), Aidi Pharmaceutical (+9.06%), Shiyao Group (+7.05%), and Ailis (+3.94%). The top five losers were: Chuangsheng Group (-16.03%), Beihai Kangcheng (-12.33%), Kedi (-11.88%), WuXi AppTec (-11.15%), and Nuocheng Jianhua (-10.99%) [1][17] Weekly Focus on Recommended Stocks - The report recommends focusing on companies with high certainty for overseas expansion, such as Sanofi Biopharma, Lianbang Pharmaceutical, and Kelun Biotech. It also highlights companies with potential overseas data catalysts, including Betta Pharmaceuticals, Hutchison China MediTech, and Ying'en Biopharma [2][21] Weekly New Drug Industry Analysis - Takeda's phase 3 clinical trials for zasocitinib have shown consistent results with previous phase 2 trials, indicating strong data reliability. The report also notes the potential for TYK2 inhibitors in treating Crohn's disease and ulcerative colitis [3][4][22] Weekly New Drug Application Approval & Acceptance - No new drug or new indication applications were approved domestically this week, but 11 new drug or new indication applications were accepted [5][26] Weekly New Drug Clinical Application Approval & Acceptance - This week, 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted [11][28]

Group 1 - The core viewpoint is that by the end of 2025, the transaction volume of innovative drug BD in China is expected to exceed $100 billion, marking a significant shift towards value-driven innovation in the pharmaceutical industry [1][2] - The 2025 China Pharmaceutical Innovation Index evaluates the comprehensive innovation capabilities of local pharmaceutical companies based on new drug development, technology transfer, and commercialization [1][2] - The release of the China Innovation Drug Index serves as an international benchmark tool for Chinese innovative drug companies, helping them understand their positioning in global competition [2] Group 2 - In the first half of 2025, BD transactions involving China contributed nearly 50% of the global transaction volume, indicating a significant role in the global market [2] - The approval of 43 innovative drugs by the National Medical Products Administration in the first half of this year represents a 59% year-on-year increase, showcasing the continuous improvement in original innovation capabilities [2][3] - The shift from being global followers to value co-creators is evidenced by record-breaking collaborations, such as those between 3SBio and Pfizer, and Innovent Biologics and Takeda [2] Group 3 - Challenges remain, including the need for original innovation and improved commercialization capabilities, as many new drugs are merely process improvements rather than true novel discoveries [4] - The establishment of a multi-dimensional value pricing and payment policy for innovative drugs is suggested to facilitate quicker access to effective medications [5] - The future is expected to see more First-in-Class products emerging, with potential for new drugs to achieve annual sales exceeding $1 billion [6] Group 4 - The necessity for Chinese innovative drugs to enter international markets is emphasized, with a focus on maximizing product value and meeting international market demands [7] - The ongoing wave of BD transactions is anticipated to continue, with a shift in focus from oncology drugs to non-oncology areas by 2026 [7] - Despite significant advancements, Chinese innovative drug companies still face challenges in competing with multinational corporations on a global scale [7] Group 5 - The importance of building a deep integration global cooperation ecosystem is highlighted, with companies encouraged to leverage unique technological platforms for international collaboration [8] - The goal is to define new therapies through a combination of Chinese innovation and global resources, ultimately benefiting a wider patient population [8]

Core Insights - The article discusses the trends in the development of autoimmune disease treatments, highlighting the significant growth in the global autoimmune drug market, which reached $156 billion in 2023 with a compound annual growth rate of 15% [1][2]. Group 1: Market Overview - The success of TNFα inhibitors and the emergence of IL inhibitors have marked a new era in treatment innovation [1]. - Leading products like Humira and Stelara are facing competition from biosimilars, while others like Dupixent and Skyrizi have set high efficacy standards in their respective indications [1][3]. - The market is expected to continue growing over the next three to five years, driven by the launch of JAK inhibitors and IL inhibitors across multiple disease areas [1][3]. Group 2: Competitive Landscape - Nine companies have six or more marketed products and pipeline drugs, indicating intense competition for leadership in the immunology field [3][4]. - The market is currently dominated by multi-indication blockbuster drugs, with significant ongoing clinical trials aimed at expanding indications for existing products [9][10]. Group 3: Innovation and Development Trends - Companies are increasingly focusing on new molecular entities (NMEs) and innovative treatment strategies, with 70% of pipelines dedicated to novel drug development [9][13]. - The emergence of Chinese pharmaceutical and biotech companies is notable, with firms like 3SBio and Jiangsu Hengrui actively researching innovative targets and NMEs [13][16]. - The industry is shifting towards more precise therapies, progressive innovations, and complex combination dynamics, with a focus on improving patient adherence and treatment convenience [18][23]. Group 4: Future Directions - The article emphasizes the importance of biomarker-driven patient stratification and the expansion of multi-indication models as foundational strategies in autoimmune drug development [21][22]. - The trend of "test and learn" is gaining traction, leading to increased trial activities in rare indications [21][23]. - The industry is also moving towards combination therapies and innovative drug delivery methods, such as oral formulations, to enhance patient convenience and treatment outcomes [24].

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， ...

格隆汇11月28日丨上海莱士(002252.SZ)在互动平台表示， 公司未进口武田白蛋白，公司代理的进口白 蛋白为基立福相关产品。 ...

Group 1 - The company, Shanghai Laishi, confirmed that it does not import Takeda's white albumin from Japan [1] - The imported white albumin that the company represents is related to the products of the company Kliba [1]

Group 1 - The innovative drug sector has rebounded significantly, with the Kexin Innovative Drug ETF (589720) rising by 2.5% and trading volume increasing [1] - BeiGene's recent Q3 financial report shows total revenue of $1.4 billion, a 41% year-over-year increase, and a GAAP net profit of $125 million, marking a turnaround from a net loss of $121 million in the same quarter last year [2] - Market attention is shifting back to fundamentals as more multinational corporations (MNCs) disclose their investment and planning in collaboration pipelines, coinciding with the upcoming national medical insurance negotiations [2] Group 2 - There is a trend of funds buying on dips, with over $300 million invested in the Kexin Innovative Drug ETF (589720) in the past 10 days, indicating a rotation in market activity [3] - The focus is returning to the essence of the innovative drug industry, moving from speculative trading to validating the value of business development (BD) partnerships through tangible actions and investments by MNCs [4] - The Chinese innovative drug sector is entering a 2.0 era, transitioning from "importing and imitating" to "innovating and exporting," supported by favorable policies and abundant clinical resources [4] Group 3 - The Kexin Innovative Drug ETF (589720) is highlighted for its high growth potential and significant elasticity, focusing entirely on the innovative drug index with a 20% price fluctuation limit [5] - The top ten components of the Kexin Innovative Drug ETF include companies like BeiGene and Boli Tianheng, with BeiGene holding a weight of 10.45% [6]