此乃要件 請即處理 閣下如對本通函任何方面或應採取的行動有任何疑問，應諮詢 閣下的註冊證券交易商、銀行經理、律 師、專業會計師或其他專業顧問。 閣下如已售出或轉讓名下所有康寧傑瑞生物製藥股份，應立即將本通函及隨附之代表委任表格送交買主或 承讓人，或經手買賣或轉讓之銀行、註冊證券交易商或其他代理，以便轉交買主或承讓人。 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通函之內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不就因本通函全部或任何部分內容而產生或因倚賴該等內容而引致之任 何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） (1) 建議授出購回股份及發行新股份的一般授權 （包括轉售或轉讓庫存股份）； (2) 建議重選退任董事； (3) 建議續聘核數師； 及 (4) 股東週年大會通告 無論 閣下是否有意出席股東週年大會，務請按代表委任表格印列的指示填妥該表格，並盡快且無論如何 不遲於股東週年大會指定舉行時間前48小時（即不遲於2025年6月10日（星期二）上午十時正）或其任何續 會指定舉行時間前48小 ...

Core Viewpoint - The pharmaceutical market, particularly innovative drug companies, is experiencing significant growth, with substantial support from policies, leading to the emergence of high-performing stocks similar to Changchun Gaoxin. Group 1: Market Performance - The Hong Kong innovative drug index has increased from 859 points at the beginning of the year to 1284 points, representing a 50% rise [1] - The mainland innovative drug index has risen from a low of 948 to a high of 1156, showing a 22% increase, indicating a significant lag compared to Hong Kong [1] Group 2: Stock Performance - Several stocks in the Hong Kong innovative drug sector have seen substantial gains, such as: - Kintor Pharmaceutical rising from 2.48 to 19.78 HKD - Akeso increasing from 1.2 to 4.3 HKD - CanSino Biologics moving from 2 to 8.73 HKD - CStone Pharmaceuticals growing from 0.8 to 3.89 HKD - Innovent Biologics increasing from 26.45 to 105.5 HKD [4] - The current bullish trend in Hong Kong's innovative drug sector is viewed as just the beginning, with expectations of a long-term market cycle lasting 50 years [4] Group 3: Historical Comparisons - Historical data from 2005 to 2007 shows that Hong Kong real estate stocks typically initiated their upward trends over six months before A-share stocks, with A-share stocks generally experiencing greater increases [5] - Examples include: - China Overseas Land rising from 2.29 to 21.95 HKD - Vanke increasing from 6.76 to 33.82 HKD - Deep Zhenye rising from 19.90 to 271.8 HKD [5] - The patterns observed in the real estate sector may provide insights into the potential trajectory of mainland innovative drug stocks, suggesting a possible follow-up to the Hong Kong market's performance [5]

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之內容概不負責，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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 KN026關鍵性II/III期臨床試驗期中分析 達到PFS主要終點 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本公司與石藥集團有限公司（股份 代號：1093）附屬公司上海津曼特生物科技有限公司合作開發的KN026（「KN026- 001」）聯合化療二線及以上治療HER2陽性GC（包括GEJ）的II/III期臨床試驗已完 成首個期中分析及期中分析結果達到PFS主要終點。 KN026-001的第2部分是一項隨機、雙盲、安慰劑對照的III期研究，旨在評估 KN026聯合化療用於一線標準治療失敗的HER2陽性晚期不可切除或轉移性GC （包 ...

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之內容概不負責，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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 於2025年AACR年會呈列的JSKN021及JSKN022的最新研究成果 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，JSKN021及JSKN022臨床前研究 的最新成果已於2025年4月25日至4月30日舉行的2025年AACR年會的壁報展示期 間（摘要展示編號：5450及5451）公佈。此研究結果概述如下。 JSKN021在臨床前研究中的藥理活性 背景：EGFR及HER3均屬於EGFR家族，在人類惡性腫瘤中廣泛過表達，使其成 為極具潛力的腫瘤治療靶點。腫瘤是一種異質性疾病，瘤間與瘤內的異質性被認 為是導致復發、轉移及對當前SO ...

2024 環境、社會及管治報告 目錄 | 關於本報告 | 3 | | --- | --- | | 關於康寧傑瑞 | 5 | | 2024年度亮點 | 7 | 可持續發展管理 11 ESG管治架構 13 董事會聲明 14 利益相關方溝通 15 重大性議題分析 16 01 穩步前行，責任管治為本 17 公司治理 19 風險管理 20 商業道德 21 保護知識產權 22 02 03 | 創新驅動，行業共進共贏 | 23 | | --- | --- | | 驅動產品創新 | 25 | | 強塑研發實力 | 26 | | 聚力合作共贏 | 28 | | 維護受試者權益 | 29 | 04 關於本報告 報告時間範圍 環境、社會及管治（「ESG」）報告（本「報告」）涵蓋的期間為2024年1月1日至2024年12月31日，部分內容向前後適度延伸。 本報告涵蓋的時間範圍與我們的2024年年報一致。 實體範圍 07 附錄 06 | 品質為基，堅守康寧匠心 | 31 | | --- | --- | | 保障產品質量 | 33 | | 嚴守安全生產 | 38 | | 精進服務品質 | 40 | | 打造負責任供應鏈 | 43 | | ...

Clinical Development and Innovation - KN035 (Envafolimab) has been commercialized since November 2021 and received registration in Macau for treating unresectable or metastatic MSI-H/dMMR adult solid tumor patients in 2024[6]. - KN026 is undergoing three Phase III clinical trials in China, with breakthrough therapy designation granted for HER2-positive gastric cancer patients who failed first-line treatment[7]. - JSKN003, a dual-target HER2 ADC, is in three Phase III clinical trials and has received breakthrough therapy designation for platinum-resistant ovarian cancer, with potential milestone payments up to RMB 3.08 billion[7]. - JSKN033, the world's first subcutaneous ADC combination therapy, has received ethics approval in Australia and is in I/II clinical trials for HER2-expressing advanced solid tumors[8]. - KN046, a bispecific antibody targeting PD-L1 and CTLA-4, has multiple ongoing clinical trials in China, the US, and Australia, with recent publications in major journals[8]. - Three clinical studies for the HER2 bispecific antibody KN026 are progressing positively, focusing on second-line GC/GEJ and first-line HER2-positive breast cancer[14]. - The ongoing clinical studies for JSKN016 are exploring multiple indications and treatment regimens, demonstrating the company's commitment to innovation[16]. - The JSKN033, a high-concentration combination formulation of ADC and immune checkpoint inhibitors, is the first subcutaneously administered ADC drug to enter clinical trials[16]. - Encouraging PFS and OS benefits were reported in a Phase II clinical trial of KN046 combined with albumin-bound paclitaxel for advanced triple-negative breast cancer, with results published in Nature Communications in February 2024[34]. - JSKN003 demonstrated promising initial anti-tumor activity and good tolerability in a Phase I clinical trial for advanced/metastatic solid tumors, presented at the AACR annual meeting in April 2024[35]. - JSKN003 was granted CDE approval to initiate a Phase III clinical trial for treating platinum-resistant recurrent epithelial ovarian cancer in December 2024[36]. - JSKN033's I/II clinical trial for advanced metastatic malignancies received CDE approval for IND application in December 2024[36]. - KN046 combined with lenvatinib showed promising results in a Phase II clinical study for advanced unresectable or metastatic HCC, published in Nature Communications in February 2025[37]. Financial Performance - The company achieved a significant year-on-year revenue growth of 192.58%, marking its first annual financial profit[18]. - The company reported a revenue of RMB 640,083,000 for the year ending December 31, 2024, representing a significant increase from RMB 218,774,000 in 2023, which is a growth of approximately 192%[32]. - Gross profit for the same period was RMB 579,767,000, up from RMB 163,537,000 in 2023, indicating a gross margin improvement[32]. - The company reported a total comprehensive income for the year ended December 31, 2024, was RMB 166.3 million, compared to a total comprehensive loss of RMB 211.4 million for the previous year[43]. - The company recorded a profit of RMB 166.3 million for the year ended December 31, 2024, compared to a loss of RMB 210.6 million in 2023[56]. - The company achieved a profit before tax of RMB 166,342,000, a turnaround from a loss of RMB 210,593,000 in the previous year[32]. - The gross margin improved to 65%, up from 60% in the previous year, due to cost optimization measures[22]. - The company plans to invest $50 million in research and development over the next two years to accelerate innovation[26]. - The company provided an optimistic outlook, projecting a revenue growth of 30% for the next fiscal year, driven by new product launches and market expansion[25]. Market Expansion and Strategic Initiatives - The global first subcutaneous PD-(L)1 inhibitor, KN035, is expanding its market presence with registration in Macau and development in the Asia-Pacific and Middle East regions[14]. - The company is actively integrating global resources to enhance its international presence and accelerate value transformation through collaborations with leading pharmaceutical companies[18]. - The company is expanding its market presence in Europe, with plans to establish a new distribution center in Germany by mid-2024[27]. - A strategic acquisition of a biotech firm was announced, which is expected to enhance the company's R&D capabilities and product pipeline[24]. - The company has maintained a focus on strategic partnerships and potential acquisitions to enhance its competitive position in the industry[32]. Corporate Governance and Leadership - The company has a strong leadership team with key figures like Ms. Liu, who has extensive experience in human resources and supply chain management, and has been with the group since October 2018[84]. - The board includes independent directors with significant industry experience, such as Dr. Guo, who has been a professor at Nanjing University since May 1999[88]. - The company is committed to maintaining high standards of governance with independent directors overseeing board activities[88]. - The board believes that having the same person serve as both chairman and CEO is beneficial for the company's operations and management[102]. - The company has adopted the principles and code provisions of the corporate governance code as its governance standard[100]. - The company has appointed new independent non-executive directors to enhance board oversight and independent judgment[95]. - The board consists of two executive directors, one non-executive director, and three independent non-executive directors[105]. - The company has established a policy for insider information to comply with the Securities and Futures Ordinance and Listing Rules[104]. - The company has adopted the standard code of conduct as per the Listing Rules Appendix C3, with no reported violations during the reporting period[104]. Employee and Corporate Culture - The company aims to make tumors controllable and treatable diseases, focusing on employee-centric culture and continuous innovation[97]. - The company has strengthened its cultural framework and requires all new employees to participate in onboarding training to understand corporate culture and policies[97]. - The company has a zero-tolerance policy for discrimination based on gender, age, race, nationality, and disability, and aims for improved diversity by 2025[135]. - As of December 31, 2024, the total number of employees is 420, with 45% male (189) and 55% female (231)[134]. - The age distribution of employees shows that 26% (109) are aged 18-30, 72% (301) are aged 31-50, and 2% (10) are over 50[134]. Risk Management and Compliance - The board of directors is responsible for risk management and internal control systems, which are reviewed annually for effectiveness[143]. - The company emphasizes a culture of risk awareness among employees, integrating risk management into strategic and operational processes[144]. - The company has established a whistleblowing policy to address employee concerns confidentially and anonymously[144]. - The board has implemented an anti-corruption policy as part of the corporate governance framework, emphasizing the commitment to ethical business practices[147]. - The company has no significant contingent liabilities or pending litigation that could adversely affect its business or financial condition as of December 31, 2024[77]. Research and Development - The company is continuously improving its biopharmaceutical research and development technology platforms, enhancing its core competitiveness[18]. - The company has established a differentiated and internationally competitive product matrix covering ADC, bispecific antibodies, and other advanced fields[14]. - The company has maintained stable business relationships with major suppliers for approximately six years[170]. - The company has a commitment to high corporate governance standards to protect shareholder interests and enhance company value[99].

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之內容概不負責，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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） (1)根據首次公開發售後購股權計劃授出購股權；及 (2)根據限制性股份獎勵計劃授出獎勵股份 本公告乃根據《香港聯合交易所有限公司（「聯交所」）證券上市規則》（「上市規 則」）第17.06A、17.06B及17.06C條而作出。 茲提述康寧傑瑞生物製藥（「本公司」，連同其附屬公司，統稱「本集團」）日期為 2020年4月14日及2021年3月23日的公告、2024年5月21日的通函及2024年6月12 日舉行之股東週年大會投票表決結果公告（「該等公告及通函」），內容有關（其中 包括）採納首次公開發售後購股權計劃（「首次公開發售後購股權計劃」）及採納限 制性股份獎勵計劃（「限制性股份獎勵計劃」）、修訂其各自的計劃規則及更新計劃 授權限額。除另有界定者外，本公告所用詞彙與該等公告及通函所界定者具有相 ...

Financial Performance - The total revenue for the year ended December 31, 2024, was RMB 640,083,000, representing a significant increase of 192.5% compared to RMB 218,774,000 in 2023[4] - Gross profit for the same period was RMB 579,767,000, up from RMB 163,537,000, indicating a gross margin improvement[4] - The company reported a profit before tax of RMB 166,342,000, a turnaround from a loss of RMB 210,593,000 in the previous year[4] - The company’s total comprehensive income for the year ended December 31, 2024, was RMB 166.3 million, compared to a total expenditure of RMB 211.4 million for the year ended December 31, 2023[15] - The company reported a profit of RMB 166.3 million for the year ended December 31, 2024, compared to a loss of RMB 210.6 million for the year ended December 31, 2023[28] - Basic and diluted earnings per share improved to RMB 0.17 in 2024 from a loss per share of RMB 0.22 in 2023[77] Research and Development - Research and development expenses were RMB 404,152,000, slightly decreased from RMB 407,524,000 in 2023, reflecting ongoing investment in innovation[4] - A research collaboration agreement was established with ArriVent BioPharma, Inc. in June 2024 to develop new antibody-drug conjugate products[7] - Completed the final OS analysis of the Phase III clinical trial for KN046 treating advanced squamous NSCLC in September 2024[8] - JSKN003's clinical trial for platinum-resistant ovarian cancer and HER2+ advanced solid tumors presented at ESMO in September 2024[8] - Approved Phase III clinical trial for KN026 combined with docetaxel for HER2+ early or locally advanced breast cancer in October 2024[8] - JSKN033's I/II phase clinical trial results for HER2-expressing advanced or metastatic solid tumors presented at the 2024 Cancer Immunotherapy Conference in November 2024[8] - JSKN003 received CDE approval for Phase III clinical trial in December 2024 for platinum-resistant recurrent epithelial ovarian cancer[8] - JSKN033's IND application for advanced metastatic malignancies approved by CDE in December 2024[8] - JSKN003 received breakthrough therapy designation from CDE in March 2025 for treating platinum-resistant recurrent epithelial ovarian cancer[10] - Multiple IND applications for JSKN016 in NSCLC and non-HER2+ breast cancer approved by CDE in March 2025[10] - KN046 combined with lenvatinib's Phase II clinical trial results published in Nature Communications in February 2025[10] Licensing and Collaborations - The company entered into a licensing agreement with Glenmark for the exclusive rights to develop and commercialize KN035 in several regions, including India and Latin America[6] - Jiangsu Kangning Jierei signed a licensing agreement worth RMB 3.08 billion for JSKN003 in mainland China in September 2024[8] - License fee income for the year ended December 31, 2024, surged to RMB 464.2 million from RMB 7.2 million in 2023, marking an increase of over 6,000%[18] Assets and Liabilities - As of December 31, 2024, total assets amounted to RMB 2,241,755,000, with net assets increasing to RMB 1,831,884,000 from RMB 1,672,112,000 in 2023[5] - Total liabilities related to lease obligations increased to RMB 9,565,000 in 2024 from RMB 4,580,000 in 2023, representing a rise of 109%[82] - The total amount of trade payables rose to RMB 39,222,000 in 2024 from RMB 27,163,000 in 2023, an increase of 44.6%[88] - The company reported contract liabilities of RMB 40,054,000 in 2024, up from RMB 25,460,000 in 2023, indicating a growth of 57.5%[90] Cash Flow and Financing - Cash and cash equivalents increased from RMB 1,086.0 million as of December 31, 2023, to RMB 1,112.1 million as of December 31, 2024[36] - Financing costs decreased from RMB 12.2 million for the year ended December 31, 2023, to RMB 9.9 million for the year ended December 31, 2024, due to changes in working capital borrowings and lower borrowing rates[25] - The company had bank borrowings of RMB 182.2 million as of December 31, 2024, with an interest rate ranging from 2.54% to 2.67%[43] Corporate Governance and Compliance - The company has complied with all applicable corporate governance code provisions for the year ending December 31, 2024, except for the separation of the roles of Chairman and CEO as per provision C.2.1[96] - The company has established an audit committee consisting of three independent non-executive directors, ensuring compliance with the listing rules[100] - The audit committee has reviewed the annual performance for the year ending December 31, 2024, and the financial statements have been audited by Deloitte[100] Future Outlook and Plans - The company plans to continue optimizing manufacturing processes and technology to enhance product quality and reduce costs[14] - The company is actively seeking strategic collaboration opportunities to maximize the commercial value of its global patent assets[14] - The company expects to utilize the remaining net proceeds by the end of 2025, depending on regulatory approvals and market conditions[106] - The company plans to hold its annual general meeting on June 12, 2025[109]

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之內容概不負責，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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003獲得國家藥監局突破性療法認定 1 關於JSKN003 JSKN003是一種靶向HER2雙表位ADC，其通過糖基定點偶聯技術將拓撲異構酶 I抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點 處。點擊反應偶聯物較馬來醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定 性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使 其在HER2表達腫瘤中具有較強的抗腫瘤活性。 關於本公司 本公司是一家中國領先的生物製藥公司，在雙特異性抗體、多功能蛋白質工程及 ADC方面擁有完善的專有技術平台。本公司高度差異化的內部管線由處於不同研 發階段的腫瘤單克隆抗體、雙特異性抗體及ADC組成，包括一種已獲國家藥監局 批准上市及三種處於臨床後期階段的藥 ...

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之內容概不負責，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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 董事會會議日期 康寧傑瑞生物製藥（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈，本公司將 於2025年3月25日（星期二）舉行董事會會議，藉以（其中包括）考慮及通過本公司 及其附屬公司截至2024年12月31日止年度之年度業績及其發佈，以及處理其他事 項。 董事長兼執行董事 香港，2025年3月6日 於本公告日期，董事會包括董事長兼執行董事徐霆博士及執行董事劉陽女士；非 執行董事左敏先生；及獨立非執行董事郭子建博士、蔚成先生及吳冬先生。 承董事會命 康寧傑瑞生物製藥 徐霆博士 ...