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].

Core Viewpoint - 康诺亚-B (02162) has initiated its first Phase III clinical trial for the dual antibody drug CM336, which aims to treat relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] Group 1: Company Developments - 康诺亚's stock price increased by over 5% during trading, currently reported at 74.80 HKD with a trading volume of 89.07 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Group 2: Clinical Trial Background - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - In the dose escalation cohort, the objective response rates (ORR) for the ≤5mg, 20-40mg, and 80-160mg groups were 17%, 71%, and 80% respectively [1] - The rates of stringent complete response or complete response in these groups were 17%, 71%, and 60% respectively [1]

Core Viewpoint - Connaissance-B (02162) has initiated its first Phase III clinical trial for CM336, a dual antibody drug, which has led to a significant increase in its stock price, reflecting positive market sentiment towards the company's progress in drug development [1] Company Summary - Connaissance-B's stock price rose over 5% during trading, closing at 75.4 HKD with a trading volume of 87.53 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients, aimed at evaluating the drug's efficacy and safety in treating relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Clinical Trial Summary - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - Results from the earlier study indicated that at a median follow-up of 12.1 months, the objective response rates (ORR) for the ≤5 mg, 20-40 mg, and 80-160 mg groups were 17%, 71%, and 80% respectively [1] - The rates of strict complete response or complete response among patients in these groups were 17%, 71%, and 60% respectively [1]

Market Overview - The Hong Kong stock market showed a volatile trend, with the Hang Seng Index closing flat after briefly surpassing 27,000 points during the day [1] - The Hang Seng Index remained at 26,545.10, with a slight change of 0.00% and a 5-day increase of 0.59% [2] - The Hang Seng China Enterprises Index rose by 0.17%, closing at 9,472.35, with a 5-day increase of 1.15% [2] - The Hang Seng Tech Index increased by 0.37%, closing at 6,294.42, with a 5-day increase of 5.09% [2] Sector Performance - Large technology stocks showed mixed performance, with NIO, SenseTime, and Hua Hong Semiconductor rising over 4%, while Tencent Music and Horizon Robotics fell over 4% [4] - Gaming stocks performed strongly, with major players like Melco International Development, Sands China, and Wynn Macau rising over 6% [6] - Gold and precious metal stocks saw gains, with Shandong Gold rising over 6% and other gold-related stocks following suit [7] - Automotive parts stocks led the gains, with New Morning Power surging over 27% [9] - Tesla-related stocks were active, with Ganfeng Lithium rising by 9% and Li Auto also showing positive movement [10] Notable Stock Movements - The top gainers included: - NIO-SW: +4.45% [5] - SenseTime-W: +4.58% [5] - Shandong Gold: +6.13% [8] - New Morning Power: +27.66% [9] - Conversely, notable decliners included: - Tencent Music: -4.04% [5] - Orange Sky Golden Harvest: -8.54% [12] - Innovent Biologics: -5.50% [13] Capital Flows - Southbound funds recorded a net inflow of HKD 9.838 billion, with HK Stock Connect (Shanghai) contributing HKD 5.283 billion and HK Stock Connect (Shenzhen) contributing HKD 4.555 billion [14] Future Outlook - The market outlook suggests that the Hong Kong stock market may perform stronger following the Federal Reserve's potential interest rate cuts, particularly in sectors like healthcare, technology, and consumer goods [15]

Investment Rating - The report indicates a positive outlook for the atopic dermatitis (AD) market, highlighting significant unmet medical needs and potential for new therapies, particularly in small molecules and biologics [4][10][12]. Core Insights - Atopic dermatitis is a chronic, recurrent inflammatory skin disease characterized by severe itching, affecting approximately 600-700 million patients globally, with around 67 million in China, indicating a substantial unmet demand for effective treatments [1][18][20]. - Recent advancements in small molecules and biologics have marked a new phase in AD treatment, with several new products entering the market, although the number remains limited [1][10][32]. - JAK inhibitors have shown excellent efficacy but come with safety concerns, while TYK2 inhibitors are emerging as a promising new option due to their selective action and potentially better safety profile [2][11][12]. - Biologics targeting IL-4Rα and IL-13 have demonstrated significant efficacy in improving skin lesions, with IL-31 showing strong itch relief capabilities [3][12][13]. - The development of dual/multi-target antibodies is seen as a new strategy to enhance treatment efficacy by combining the advantages of different targets [4][13][21]. Summary by Sections Investment Highlights - The AD market has immense potential, with a pressing need for effective therapies [4][10]. - The patient population is large, with over 600 million affected globally, necessitating urgent treatment options [1][18]. Disease Characteristics - AD is characterized by chronic inflammation and severe itching, significantly impacting patients' daily lives [1][14]. - The disease burden is heavy, with a complex pathogenesis involving multiple factors, primarily driven by Th2-type inflammation [21][24]. Current Treatment Landscape - Traditional therapies have safety concerns, leading to a shift towards biologics and small molecules [32][35]. - JAK inhibitors are the most approved class of drugs for AD, but they carry black box warnings due to safety issues [11][12]. - Emerging therapies, particularly TYK2 inhibitors, show promise for better safety and efficacy [2][11]. Biologics and Emerging Therapies - Currently approved biologics include IL-4Rα, IL-13, TSLP, and IL-31, with ongoing research into additional targets [3][12][13]. - Dual/multi-target antibodies are being explored to improve treatment outcomes and extend dosing intervals [4][13][21]. Market Potential - The report emphasizes the significant market potential for AD treatments, with projected growth driven by increasing patient numbers and the introduction of innovative therapies [4][10][20].

Core Insights - Complement drugs are specifically designed to treat diseases related to abnormal activation or suppression of the complement system, with a complex development history that faced significant challenges until the first drug, Soliris, was approved in 2007 [1][4] - The market for complement drugs is expanding rapidly, with a projected global market size of $8.179 billion in 2024, reflecting a year-on-year growth of 23.4%, primarily driven by advancements in treatment for eye diseases [1][6] - The leading complement drugs in the market are AstraZeneca's C5 antibodies, Soliris and Ultomiris, which together are expected to account for 79.6% of total sales in 2024 [1][6][7] Industry Overview - The complement drug industry has evolved to include over ten approved drugs, utilizing various forms such as monoclonal antibodies, small molecule inhibitors, cyclic peptides, and nucleic acid aptamers, indicating a diverse technological landscape [1][4] - The expansion of indications from rare blood diseases to more common conditions signifies a maturation in the development of complement drugs, with ongoing research opening new therapeutic areas [1][4][8] Market Dynamics - The sales of Ultomiris are projected to grow significantly, from $339 million in 2019 to $3.924 billion in 2024, surpassing Soliris, which is expected to see a decline in sales by 17.7% to $2.588 billion in 2024 [7] - Domestic companies such as Heng Rui Medicine and Hai Si Ke are actively entering the complement drug market, with over ten clinical trials registered in China, primarily focusing on IgA nephropathy [1][8] Future Trends - The competition in the complement drug market is expected to intensify with the introduction of more drugs, emphasizing technological innovation and cost reduction to enhance accessibility [8] - There is a growing focus on multi-target and combination therapy strategies, which may improve treatment efficacy and reduce side effects, as well as an expansion of applications to include more rare and autoimmune diseases [8]

Core Viewpoint - The pharmaceutical industry is experiencing structural differentiation, with the innovative drug sector (Biotech) emerging as a significant growth driver, showcasing a revenue increase of 14.12% in the first half of 2025, particularly a remarkable 44.63% growth in Q2 [1][4]. Industry Overview - The overall pharmaceutical industry reported a slight revenue decline of 1.15% in Q2 2025, but net profit showed a positive growth of 0.79% [1]. - Despite challenges such as centralized procurement and external disruptions, there are signs of performance recovery driven by policy optimization, commercial insurance expansion, and AI empowerment [1][2]. Financial Performance - The Biotech sector's revenue growth in H1 2025 was 14.1%, with Q2 alone achieving a growth rate of 44.6% [6]. - The gross profit margin for the Biotech sector was 85.0%, indicating a narrowing of losses and a shift towards profitability [6]. - The sales expense ratio increased, but management and R&D expense ratios decreased, reflecting cost control and efficiency improvements [6]. Growth Drivers - The growth in innovative drugs is attributed to the launch of effective and safe new drugs, supportive national policies, and significant revenue from licensing agreements [4][6]. - The average transaction amounts for licensing agreements in 2025 have reached global averages, indicating a robust international market for Chinese innovative drugs [9][11]. Market Trends - The innovative drug sector is transitioning from a "burning cash" phase to a "profit-making" phase, with several companies reporting net profits for the first time [6][14]. - The number of significant licensing deals has surged, with China accounting for over 25% of global heavy-weight transactions in 2025 [11][13]. Investment Opportunities - The innovative drug sector is entering a harvest phase, with expectations for further growth driven by upcoming clinical data and favorable economic conditions [14]. - Investors are encouraged to consider diversified investment products, such as ETFs, to mitigate risks associated with individual stock selection in the innovative drug space [14][16].