Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has received approval from the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer, in combination with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant treatment of colorectal cancer [1] - The combination therapy with Sintilimab significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - Innovent Biologics (01801) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients, in combination with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

Core Viewpoint - Innovent Biologics (01801.HK) announced that its drug, IBI310 (Ipilimumab N01 injection), has been approved by the National Medical Products Administration (NMPA) in China for use in neoadjuvant therapy for resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer patients when combined with Sintilimab [1] Group 1 - IBI310 is the first domestically approved anti-CTLA-4 monoclonal antibody in China [1] - It is also the first anti-CTLA-4 monoclonal antibody globally approved for neoadjuvant therapy in colorectal cancer [1] - The combination therapy significantly improves the pathological complete response rate for MSI-H/dMMR colorectal cancer patients [1]

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，概不對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。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 達伯欣® （伊匹木單抗N01注射液）獲中國國家藥品監督管理局批准 聯合信迪利單抗用於結腸癌新輔助治療 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈達伯欣® （伊匹木單抗N01注射液，細胞毒性T 淋巴細胞相關蛋白4（「CTLA-4」）單克隆抗體（「單抗」），研發代號：IBI310）獲得 中國國家藥品監督管理局（「NMPA」）批准上市，聯合信迪利單抗用於可手術切除 的IIB-III期微衛星高度不穩定型（「MSI-H」）或錯配修復缺陷型（「dMMR」）結腸 癌患者的新輔助治療。達伯欣® （伊匹木單抗N01注射液）是中國首個獲批的國產抗 CTLA-4單抗，也是全球首個 ...

Investment Rating - The report suggests a positive investment outlook for the medical device sector, particularly in brain-computer interface devices, which are expected to see accelerated commercialization due to supportive policies [1][3]. Core Insights - Recent policies have significantly increased support for innovation in medical devices, with the National Medical Products Administration actively promoting faster market entry for brain-computer interface devices, indicating a diverse application landscape and substantial future potential [1][3]. - The pharmaceutical sector is witnessing positive developments, such as GSK's approval of mepolizumab for a new indication in COPD patients, marking it as the first monthly administered biologic in China, which is expected to reduce the annual incidence of severe exacerbations significantly [1][32]. - The report highlights the approval of Wegovy® tablets in the U.S. for weight management, emphasizing its potential impact on the market as the first oral GLP-1 receptor agonist for this purpose [37][40]. Summary by Sections Pharmaceutical Sector - Mepolizumab has been approved for COPD treatment in China, with a monthly dosing schedule, targeting a significant patient population [1][32]. - The A/H share innovation drug sector maintains high activity levels, with new drug approvals and cross-border transactions remaining robust [16][28]. Biologics - Wegovy® tablets have been approved in the U.S. for weight management, showing similar weight loss efficacy to its injectable counterpart, with a significant portion of participants achieving substantial weight loss [37][40]. CXO and Pharmaceutical Supply Chain - The CXO sector continues to show upward momentum, supported by a stable order backlog, with November financing levels slightly above the annual average [44][46]. Medical Devices - The centralized procurement process for high-value medical consumables is progressing steadily, with high selection rates in multiple rounds of bidding, indicating a favorable environment for leading domestic companies [2][52]. Retail Pharmacy - The industry is undergoing a consolidation phase, with leading companies expected to benefit from increased market share through mergers and acquisitions [2][3]. Medical Services and Consumer Healthcare - Aier Eye Hospital's acquisition of 39 institutions for 960 million yuan strengthens its market position, with the acquired entities showing signs of financial recovery [2][3].

Core Viewpoint - The GLP-1 class drugs, once hailed as "weight loss miracle drugs," are transitioning from high-priced innovative medications to more accessible healthcare products, with a significant price drop observed in the market as major pharmaceutical companies prepare for increased competition and the expiration of patents in 2026 [1][10][12]. Pricing Trends - The recent price reductions for semaglutide and tirzepatide are not isolated incidents but show systematic characteristics, with semaglutide's lowest price dropping to 329 yuan per injection for the diabetes version and 388 yuan for the weight loss version, marking a significant decrease from previous market prices [2][4]. - The price of tirzepatide has also shown downward movement, with the lowest price for the 2.4ml:10mg specification falling below 500 yuan for the first time, indicating a clear shift in pricing strategy [4]. Strategic Moves by Companies - Novo Nordisk and Eli Lilly are strategically lowering prices ahead of the 2026 patent expiration for semaglutide, aiming to establish price anchors and secure market share before the entry of domestic biosimilars and innovative drugs [1][11]. - Eli Lilly's tirzepatide is set to be included in the medical insurance system starting January 1, 2026, with pre-sale prices already established on e-commerce platforms, indicating a strategy to align with future insurance pricing [8][10]. Market Competition and Future Outlook - The market for GLP-1 weight loss drugs is expected to intensify, with predictions of a price war as more competitors enter the market, particularly in the biosimilar segment, which could see prices drop by an additional 20%-50% [10][12]. - The introduction of oral GLP-1 medications, such as semaglutide's oral version approved by the FDA, is anticipated to expand the market further, appealing to patients who prefer non-injection options [16][17]. Domestic Innovations - Domestic companies like Innovent Biologics and HengRui Medicine are positioned to challenge the original drug market with their innovative products, such as the dual-target drug MaShidu and HRS9531, which are expected to be approved in 2026 [13][14]. - The market is projected to evolve into a multi-product landscape with a price tiering system, where original drugs, innovative domestic products, and biosimilars coexist, driven by varying patient needs and treatment stages [18]. Unmet Market Needs - Despite the growing availability of GLP-1 drugs, the penetration rate among the obese population in China remains low at approximately 1%, indicating significant unmet demand in the market [18].

Core Viewpoint - The Chinese innovative pharmaceutical industry is experiencing a surge in business development (BD) transactions, but the secondary market's reaction has been mixed, with many companies seeing stock price declines despite positive announcements [2][6][10]. Group 1: Recent BD Transactions - Numerous BD transactions have been announced recently, including partnerships between Jiangsu Zaiming and Ipsen, and between Akeso and AstraZeneca, among others [2]. - In 2023, over 100 license-out transactions were completed in China, totaling more than $110 billion [4]. - As of December 21, 2025, there have been 15 transactions with upfront payments exceeding $100 million, and 37 transactions with total amounts over $1 billion, ranking second only to the U.S. [5]. Group 2: Market Reactions - Following the announcement of BD transactions, stock prices have shown varied responses; for instance, Akeso's stock fell by 13.58% on December 22, while Qianxin Bio's stock rose by 1.44% on the same day [3][6]. - A total of 37 BD transactions in A-shares and Hong Kong stocks this year resulted in 21 instances of stock price increases and 15 instances of declines on the first trading day after the announcements [6]. - The overall sentiment in the market has shifted from enthusiasm to a more rational approach, with stock prices reflecting this change [8][10]. Group 3: Industry Insights - Industry experts suggest that the complexity and long-term nature of innovative drug development require a rational approach from both capital and product markets [6][10]. - The current trend indicates that many Chinese pharmaceutical companies are still reliant on the "borrowed boat" strategy for international expansion, with a focus on licensing out rather than direct commercialization [12][13]. - The choice of out-licensing models varies, with smaller companies typically opting for complete licensing, while larger firms are exploring co-development models to retain longer-term benefits [13][14].

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed down 0.26% with a trading volume of 221 million yuan on December 26 [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of December 25, 2024, the fund's latest share count was 10.467 billion shares, with a total size of 8.204 billion yuan, reflecting a year-to-date increase of 2547.36% in shares and 2071.41% in size [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 56.94% during the management period [2] - The top holdings of the fund include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant weightings in the portfolio [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2]

Core Insights - The approval of the dual immunotherapy regimen for the treatment of resectable IIB-III stage MSI-H/dMMR colorectal cancer marks a significant breakthrough in the field of immunotherapy for colorectal cancer [1][3][4] - This therapy is the first and only dual immunotherapy regimen approved globally for neoadjuvant treatment in colorectal cancer, potentially changing treatment paradigms for patients with this specific cancer type [1][3] Group 1: Treatment Approval and Characteristics - The National Medical Products Administration approved the new drug application for Daberxin (Ipilimumab N01 injection), which can be used in combination with Daberush (Sintilimab injection) for neoadjuvant therapy in patients with resectable IIB-III stage MSI-H/dMMR colorectal cancer [1] - MSI-H/dMMR colorectal cancer accounts for approximately 15% of all resectable colorectal cancer cases, and these tumors are less responsive to traditional chemotherapy [1][3] Group 2: Clinical Implications and Efficacy - Existing treatments for locally advanced MSI-H/dMMR colorectal cancer primarily involve radical surgery and postoperative adjuvant chemotherapy, with a recurrence or metastasis rate of 10%-30% among patients [3] - The dual immunotherapy regimen has shown to significantly increase the pathological complete response rate in neoadjuvant therapy, potentially reducing the need for postoperative adjuvant chemotherapy [3][4] Group 3: Patient Considerations and Safety - For patients with MSI-H/dMMR colorectal cancer, surgery may not be the only option due to the challenges associated with radical surgery and poor prognosis [4] - While the dual immunotherapy regimen is generally considered safe and controllable, there are potential immune-related adverse reactions that may occur, necessitating timely medical intervention for severe cases [4]

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the launch of the anti-CTLA-4 monoclonal antibody, Ipilimumab N01 injection (brand name: Daberxin), developed by Innovent Biologics, for neoadjuvant treatment in patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer, marking it as China's first domestically approved anti-CTLA-4 monoclonal antibody and the first globally for this indication [1][5]. Group 1 - The approval is based on the results of a randomized, controlled, multi-center Phase III registration study (NeoShot-III, NCT05890742) conducted in China, which aimed to evaluate the efficacy and safety of Ipilimumab N01 in combination with Sintilimab compared to direct radical surgery [3][7]. - The primary endpoints of the study included pathological complete response (pCR) and event-free survival (EFS) [3][7]. - The interim analysis of the NeoShot-III study showed that the predefined primary endpoints were met, as assessed by the Independent Data Monitoring Committee (iDMC) [3][7]. Group 2 - As of November 28, 2024, among the first 50 patients in the trial group, 41 achieved pathological complete response after neoadjuvant treatment, resulting in a pCR rate of 82% [4][8]. - In terms of safety, the combination of Ipilimumab N01 and Sintilimab did not significantly increase additional safety risks compared to the direct surgery group [4][8]. - The Chief R&D Officer of Innovent Biologics, Dr. Zhou Hui, emphasized the significant unmet clinical need for neoadjuvant treatment in resectable MSI-H/dMMR colorectal cancer, highlighting the importance of the NeoShot-III study's interim analysis for this treatment area [4][8].