Core Viewpoint - Despite significant business development (BD) agreements exceeding $10 billion, the stock prices of innovative pharmaceutical companies remain sluggish, indicating a disconnect between market expectations and actual performance [1][2]. Group 1: Market Performance - The Hong Kong Stock Connect innovative drug index has declined from over 1240 points on October 9 to 1110 points, reflecting a drop of approximately 10.5% [1][2]. - Notable companies like 信达生物 (Innovent Biologics) have seen their stock prices fall despite announcing major collaborations, with 信达生物's stock dropping 1.96% to 85.2 HKD per share on October 22 [2]. - Over the past month, the innovative drug sector has experienced a 16% decline from a peak of 1326 points on September 8, with several companies like 诺诚健华 (Nocera) and 康诺亚-B (CanSino) seeing stock drops exceeding 19% [2][4]. Group 2: Financial Performance - Many innovative drug companies have reported revenue growth, yet profitability remains a concern, with only four out of the listed companies achieving positive net profits [6][7]. - 康诺亚-B reported a staggering 812.1% year-on-year revenue increase, while other companies like 诺诚健华 and 信达生物 also showed significant revenue growth of over 40% [6][7]. Group 3: Industry Dynamics - The innovative drug sector is characterized by high competition and a high rate of project failure, with a significant percentage of BD agreements facing termination [8]. - The long-term outlook for the Chinese innovative drug industry remains positive, driven by an increase in BD transactions, although the market is becoming increasingly competitive [8][9]. - Analysts suggest that the recent stock price adjustments may be a result of previously overly optimistic expectations regarding BD agreements, and the market may be entering a phase of stabilization [10].

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]

Core Viewpoint - The Hong Kong pharmaceutical sector has been experiencing a continuous decline, with significant drops in stock prices for several companies as of October 14. Group 1: Stock Performance - Vya Bio (01873.HK) has seen a decline of 7.53%, trading at 2.58 HKD [2] - Gilead Sciences-B (01672.HK) has dropped by 7.09%, with a current price of 9.17 HKD [2] - Connexa-B (02162.HK) has decreased by 5.74%, now priced at 64 HKD [2]

Group 1 - Pharmaceutical stocks have been experiencing a continuous decline, with notable drops in companies such as Viatris (01873) down 7.53% to HKD 2.58, and Singlomics (01672) down 7.09% to HKD 9.17 [1] - Huaxin Securities indicates that the trend of going global will continue into Q3 2025, but there are fewer significant business developments (BD) from listed companies, and NewCo-style BDs have not met market expectations [1] - The escalation of Sino-US trade conflicts may raise concerns about future decoupling risks, but the shift of global innovative R&D towards more efficient Chinese solutions is an unstoppable trend [1] Group 2 - Cinda Securities believes that Chinese innovative pharmaceutical companies are gaining global competitiveness in various niche markets, and while there may be short-term policy impacts, the long-term industry trend remains unchanged [2] - The innovative drug sector is expected to be a key focus in the next 2-3 years, despite potential short-term pullbacks [2] - The CXO sector is currently in a recovery phase, with continuous growth in performance expected to restore market confidence, and the recent iterations of the Biodefense Act have had minimal impact on leading companies [2]

Group 1 - The pharmaceutical stocks have been experiencing a continuous decline, with notable drops in companies such as Viatris (down 7.53% to HKD 2.58), Genscript Biotech (down 7.09% to HKD 9.17), and CanSino Biologics (down 5.74% to HKD 64) [1] - Huaxin Securities indicates that the trend of going global will continue into Q3 2025, but there are fewer significant business developments (BD) from listed companies, and the NewCo format of BD has not met market expectations [1] - The escalation of Sino-US trade conflicts may raise concerns about future decoupling risks, but the shift of global innovative research and development towards more efficient Chinese solutions is an unstoppable trend [1] Group 2 - Cinda Securities believes that Chinese innovative pharmaceutical companies are gaining a foothold on the global stage, possessing global competitiveness in various niche areas, despite potential short-term policy impacts [2] - The innovative drug sector is expected to remain a key focus for the next 2-3 years, with the CXO industry playing a crucial role in the global innovative drug supply chain [2] - The revised version of the Biodefense Act has undergone multiple iterations, with minimal impact on leading companies, and the CXO sector is currently experiencing a recovery phase, with continuous growth in performance likely to restore market confidence [2]

Core Viewpoint - The Hong Kong biopharmaceutical sector experienced a significant decline, with major companies reporting substantial drops in stock prices, indicating a bearish trend in the market [1]. Group 1: Stock Performance - Innovent Biologics (099660) saw a decline of 11.54%, with a latest price of 16.640 and a market capitalization of 293.36 billion, despite a year-to-date increase of 171.90% [2]. - Rongchang Biologics (09995) dropped by 9.20%, priced at 108.600, with a total market value of 612.08 billion, and a remarkable year-to-date increase of 654.17% [2]. - Kelun-Biotech (06990) fell by 7.71%, with a latest price of 533.000 and a market cap of 1,242.88 billion, while still showing a year-to-date increase of 226.39% [2]. - Tigermed (03347) decreased by 6.86%, priced at 43.960, with a market capitalization of 378.51 billion and a year-to-date increase of 44.25% [2]. - WuXi AppTec (02268) experienced a decline of 6.22%, with a latest price of 77.650 and a market cap of 954.09 billion, maintaining a year-to-date increase of 153.34% [2]. - CanSino Biologics (09926) dropped by 5.15%, priced at 134.500, with a market capitalization of 1,238.94 billion, and a year-to-date increase of 121.58% [2]. - Other companies like Junshi Biosciences (01877) and BeiGene (06160) also reported declines, with respective decreases of 3.16% and 2.48% [2].

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9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 康諾亞生物醫藥科技有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2025年10月2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) | 02162 | 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 ...

Core Insights - The public fund industry has experienced a fruitful year in the structural bull market, with active equity funds making a significant comeback, particularly supported by the AI computing and innovative pharmaceutical sectors [1][2]. Group 1: Fund Performance - A total of 53 funds have achieved over 100% returns year-to-date as of September 30, with 42 of these being active equity funds, showcasing the fund managers' effective strategies in high-growth sectors [2][4]. - The top-performing fund, managed by Ren Jie, achieved a return of 194.49%, heavily investing in the overseas computing industry chain, with significant contributions from stocks like Shenghong Technology, which surged 581% this year [2][3]. - Other notable funds include Zhang Wei's fund with a 155.09% return, focusing on Hong Kong's innovative pharmaceuticals, and Feng Ludan's fund with a 140.86% return, both capitalizing on the AI industry chain [3]. Group 2: Commodity Performance - Gold ETFs have emerged as the standout performers in the commodity fund sector, with all 14 gold ETFs showing gains exceeding 40% year-to-date, driven by rising international gold prices [5][6]. - The highest-performing gold ETFs, managed by Zhao Xu and Rong Ying, reported returns of 41.48% and 41.47%, respectively, reflecting strong long-term investment value [5][6]. Group 3: Market Outlook - Looking ahead to Q4, several fund companies suggest maintaining a focus on growth sectors while also considering cyclical and consumer stocks, as the market has already seen significant gains [7][8]. - The ongoing AI technology innovation is expected to provide a premium valuation for related assets, despite potential short-term volatility [8][9]. - The overall market sentiment remains bullish, with continued optimism for emerging technologies and cyclical financial sectors, particularly in the context of the "anti-involution" policies that may enhance competition in the renewable energy sector [9].

Core Insights - The report by Zhongyou Securities focuses on the development of drugs in the autoimmune (self-immune) field, analyzing market demand, dual-antibody research priorities, and related investment targets [1][3]. Market Demand - The autoimmune field has a large patient base and long medication cycles, leading to the potential for blockbuster drugs, such as Dupilumab (Dupi), which has annual sales exceeding $10 billion. Key indications like atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) have millions of affected patients, with nearly 9 million patients accessible to biological agents [1][2]. - Existing therapies still have unmet needs, including the need for long-acting formulations to reduce dosing frequency and improve efficacy, as well as expanding the patient population currently limited by screening criteria [1][2]. Dual-Antibody Research Focus - From the perspective of type 2 inflammation mechanisms, targets can be categorized into upstream (e.g., TSLP, IL-33) and downstream (e.g., IL-4, IL-13). Single-target monoclonal antibodies have limited efficacy, making dual antibodies an important direction due to their synergistic effects. In respiratory diseases, the TSLP×IL-13 (or IL-4R) dual antibody shows significant advantages, with clinical data indicating better reductions in FeNO and eosinophils compared to single-target drugs [2][3]. - The report emphasizes the potential of TSLP dual antibodies, highlighting leading global progress from companies like Sanofi (Lunsekimig) and Pfizer (triple antibodies), as well as domestic advancements from companies like Kangnuo (CM512) and Innovent (IBI3002) [2][3]. Investment Targets - Key investment targets include Kangnuo (CM512), which is leading in domestic progress, Innovent (IBI3002), and Qianxin Biotechnology (QX030N), with a focus on dual-antibody development [3]. Conclusion - Overall, TSLP dual antibodies in the autoimmune field show significant potential and may become the next generation of blockbuster drugs, driven by high patient numbers and unmet medical needs [1][3].

Company Overview - Keymed Biosciences Inc. focuses on innovative biotherapies for autoimmune and oncology treatments, with multiple candidates in clinical/commercial stages[16]. - The company has established a comprehensive integrated platform covering all key functions of biopharmaceutical development, enhancing efficiency in drug discovery and development[16]. - Keymed's proprietary technology includes an innovative antibody discovery platform and a novel T cell redirecting bispecific antibody platform[16]. - The company aims to advance a diverse pipeline of differentiated antibody therapies, including monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, and small nucleic acid drugs[16]. - Keymed collaborates with other pharmaceutical and biotech companies to enhance internal drug discovery and development capabilities[16]. - The company is committed to cost-effective and rapid discovery, construction, scaling, and advancement of its innovative therapies[16]. - Keymed's candidates are leading competitors in their respective therapeutic areas, indicating strong market positioning[16]. - The company is focused on maintaining a solid foundation in biomedical research to support its development efforts[16]. - Keymed's operational strategy includes a focus on target validation, lead molecule discovery and optimization, and clinical development[16]. Financial Performance - Revenue for the six months ended June 30, 2025, reached RMB 498,752 thousand, a significant increase from RMB 54,682 thousand in the same period of 2024, representing a growth of approximately 812%[57]. - Gross profit for the same period was RMB 465,276 thousand, compared to RMB 50,946 thousand in 2024, indicating a substantial increase in profitability[57]. - The pre-tax loss for the six months ended June 30, 2025, was RMB 75,664 thousand, a decrease from RMB 330,524 thousand in the same period of 2024, indicating improved financial performance[57]. - The company reported a loss before tax of RMB 75,664,000, an improvement from a loss of RMB 330,524,000 in the prior year[140]. - The company reported a net loss of RMB 336,745 thousand, compared to a net loss of RMB 330,524 thousand for the same period in 2024, indicating a slight increase in losses[149]. - The company’s total liabilities increased to RMB 1,435,554,000 from RMB 1,291,354,000, indicating a rise in financial obligations[146]. - The company’s net asset value rose to RMB 3,195,338,000 from RMB 2,475,212,000, reflecting a solid increase in equity[146]. Research and Development - The company is conducting a Phase III clinical trial for CM310 in adolescents with moderate-to-severe atopic dermatitis, focusing on long-term safety assessments[22]. - CMG901 (AZD0901), a Claudin 18.2 antibody-drug conjugate, has received fast track and orphan drug designations from the FDA for treating advanced gastric cancer[23]. - The company is advancing multiple clinical studies for CMG901 (AZD0901) in various solid tumors, including pancreatic and biliary cancers[24]. - CM512, a dual-specificity antibody targeting TSLP and IL-13, shows potential for effective suppression of allergic inflammatory responses[25]. - The company has initiated two Phase II clinical trials for CM512, focusing on moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps, with patient enrollment ongoing[27]. - CM336, a bispecific antibody targeting BCMA and CD3, has completed patient enrollment in a Phase I/II clinical study for relapsed or refractory multiple myeloma[31]. - CM313, a CD38-targeting monoclonal antibody, is undergoing a Phase II clinical study for primary immune thrombocytopenia, with patient enrollment completed[35]. - The company is preparing to initiate multiple Phase II studies for CM313 in various conditions, including IgA nephropathy and refractory aplastic anemia[36]. Collaborations and Licensing - AstraZeneca has exclusive global rights for the research, development, registration, production, and commercialization of CMG901 (AZD0901) as of February 2023[23]. - A licensing agreement with Belenos Biosciences grants exclusive rights for CM512 and CM536 outside Greater China, with potential milestone payments up to $170 million[27]. - The company has entered into an exclusive licensing agreement with Ouro Medicines Ltd for CM336, with potential additional payments up to $610 million[34]. - The company has entered into multiple licensing agreements, including a USD 10,000,000 upfront payment agreement with Belenos Biosciences, contributing RMB 3,155,000 in revenue from related R&D support services[171]. Production and Capacity - The production capacity at the Chengdu facility has reached 20,500 liters, compliant with national and FDA cGMP regulations, ensuring high-quality antibody drug production[48]. - The company plans to further expand its cGMP-compliant production capacity to meet the anticipated increase in production demand[56]. Shareholder and Governance - The company has adopted the Corporate Governance Code to ensure accountability and protect shareholder interests[81]. - As of June 30, 2025, Dr. Bo Chen holds a 25.16% stake in the company through Moonshot Holdings Limited, which he controls[98]. - Moonshot Holdings Limited also holds 75,151,482 shares, representing a 25.16% ownership in the company[101]. Employee and Operational Information - As of June 30, 2025, the company had a total of 1,469 full-time employees, with 7 employees working overseas[80]. - The company issued 375,250 restricted stock units under the 2021 plan and 0 under the 2022 plan during the reporting period[80]. Cash Flow and Assets - Cash and cash equivalents, along with bank deposits, increased by RMB 640 million to RMB 2,796 million, mainly due to the issuance of 19 million new shares[67]. - The company’s cash flow from operating activities for the six months ended June 30, 2025, was a net outflow of RMB 180,956 thousand, an improvement from a net outflow of RMB 365,921 thousand in the prior year[151]. - Total cash and cash equivalents at the end of the period increased to RMB 941,714 thousand, up from RMB 709,912 thousand as of June 30, 2024[153]. Regulatory and Compliance - The audit committee confirmed compliance with applicable accounting principles and standards for the interim financial information[87]. - The company has not reported any significant adverse changes regarding regulatory approvals for its candidate drugs as of the report date[45].