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: | 2026年1月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 中國抗體製藥有限公司 | | | | 呈交日期: | 2026年2月4日 | | | | I. 法定/註冊股本變動 不適用 | | | | | 備註： | | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | | FF301 第 1 頁 共 10 頁 v 1.2.0 FF301 II. 已發行股份及/或庫存股份變動及足夠公眾持股量的確認 | 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) | 03681 | 說明 | 不適用 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股 ...

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12月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 中國抗體製藥有限公司 | | | | 呈交日期: | 2026年1月7日 | | | | I. 法定/註冊股本變動 | 不適用 | | | | 備註： | | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | | FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 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) | 03681 | 說明 | | 不適用 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | | 庫 ...

Market Performance - The Hong Kong stock market experienced a strong upward trend on December 12, with the Hang Seng Index rising by 446.28 points, or 1.75%, closing at 25,976.79 points [1] - The Hang Seng Tech Index increased by 103.46 points, or 1.87%, closing at 5,638.05 points [1] - The China Enterprises Index rose by 145.07 points, or 1.62%, closing at 9,079.35 points [1] - The Red Chip Index gained 47.77 points, or 1.16%, closing at 4,150.4 points [1] Sector Performance - Technology stocks saw significant gains, with NetEase rising over 4%, and Tencent, Alibaba, and Lenovo increasing by over 2% [1] - Power equipment stocks surged, with Dongfang Electric rising over 13% [1] - Gold stocks generally rose, with Zijin Mining International increasing by over 3% [1] - Chinese brokerage stocks saw a late rally, with China Galaxy rising over 6% [1] - Insurance stocks strengthened in the afternoon, with China Pacific Insurance and China Life both rising over 5% [1] - AIGC concept stocks and real estate blue-chip stocks also saw gains [1] - However, the Everbright system and tobacco stocks declined [1] Company News - Hong Kong Electronic Commerce reported a total merchandise transaction value of HKD 636 million in November, a year-on-year decrease of 7.4% [2] - BOE Technology Group signed a total product processing agreement with its Vietnam subsidiary [2] - China Galaxy completed the issuance of a short-term corporate bond worth 4 billion yuan [2] - Cloudy Technology plans to establish a joint venture focusing on innovative robotic solutions [3] - Cloudtop New Horizon signed a commercialization service agreement with Haisen Bio [3] - Peijia Medical's TaurusTrio transcatheter aortic valve system received approval from the National Medical Products Administration [3] - China Antibody's SM17 new drug research application was accepted by the National Medical Products Administration [4] - Hengyi Holdings plans to undergo capital restructuring and fundraising activities [5] Institutional Insights - GF Securities noted that the Hong Kong stock market is more sensitive to external risks, with potential rebounds expected in mid to late December and early January [6] - Dongwu Securities believes the market is still in a left-side phase, requiring patience for a rebound [6] - Everbright Securities indicated that while there is significant room for growth compared to previous bull markets, the current market may lack strong catalysts [6] - Guoxin Securities highlighted that the recent net inflow of southbound funds into the Hong Kong market exceeded 110 billion yuan in November, indicating strong liquidity and a willingness to invest at lower levels [6] - The forecast for the Hong Kong market in 2026 is expected to range between 30,000 and 32,000 points [6] Industry Trends - The ice and snow economy is emerging as a new growth point, encompassing ice and snow sports, tourism, equipment, and culture [7] - This sector is characterized by a long industrial chain, significant spillover effects, and high social benefits, contributing to regional economic development [7] - The increasing popularity of ice and snow sports and tourism is transforming "cold resources" into a "hot economy," leading to rapid growth in the ice and snow industry [7] - There is a recommendation to focus on ice and snow sports brands with marginal improvements and stable dividend-paying leading companies [7]

中国抗体-B(03681)发布公告，于2025年12月11日，一项SM17针对炎症性肠病("IBD")的新药研究申请 ("IND")，已提交予中国国家药品监督管理局("NMPA")药品审评中心("CDE")，并已获受理。 该IND申请获批后，公司已完成或正在进行的健康志愿者1期临床试验数据可直接用于支持IBD适应症推 进至2期临床开发。该IND申请代表着SM17治疗范围从特应性皮炎("AD")拓展至IBD的重要里程碑，涵 盖克罗恩病("CD")及溃疡性结肠炎("UC")等慢性、衰竭性疾病，这些疾病存在显著未满足的医疗需求。 IL-25是一种关键细胞因子，与炎症性肠病(包括CD和UC)的病理变化有关。这类慢性炎症性肠病源于对 正常无害的共生菌产生的功能失调性免疫反应。视乎主导的辅助性T细胞亚群而定，这些免疫反应可分 为Th1型、Th2型或Th17型驱动通路，每种通路均与特定的细胞因子谱相关。IBD患者可能出现严重腹 泻、腹痛、直肠出血及体重减轻等症状，在疾病晚期常并发瘘管、肠道狭窄甚至需要结肠切除手术。除 躯体疾病负担外，IBD的反覆发作特性显著损害患者生活品质，伴随高发的焦虑、抑郁及工作能力下 降。全球每年用 ...

Core Viewpoint - China Antibody-B (03681) has submitted an Investigational New Drug (IND) application for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA), which has been accepted [1] Group 1: Drug Development and Clinical Trials - The IND approval allows the use of data from completed or ongoing Phase 1 clinical trials in healthy volunteers to support the advancement of IBD indications to Phase 2 clinical development [1] - SM17 is currently undergoing a formulation conversion bridging clinical trial, expected to complete by the end of February next year, with plans to enter Phase 2 clinical trials for atopic dermatitis (AD) by mid-2026 [4] Group 2: Mechanism of Action - SM17 is a novel humanized IgG4-k monoclonal antibody that targets the IL-25 receptor to modulate type II inflammatory responses, blocking the signaling cascade induced by IL-25, which is associated with inflammatory bowel diseases [2] - The drug has dual potential benefits in Crohn's disease (CD) by regulating Th17-driven inflammation and exhibiting anti-fibrotic effects, which may help improve complications such as bowel strictures and fistulas [2] Group 3: Market Opportunity and Unmet Medical Needs - IBD, including CD and ulcerative colitis (UC), presents significant unmet medical needs, with existing therapies failing to meet the needs of 20% to 50% of patients due to primary non-response or secondary loss of response [3] - The global annual cost for managing IBD is estimated to exceed $34 billion, highlighting the substantial market opportunity for effective treatments [3] - The expansion of SM17's indications from AD to IBD represents a significant clinical and commercial opportunity to address unmet medical needs in this area [4]

Group 1 - The core point of the news is that China Antibody-B (03681.HK) has submitted a new drug research application (IND) for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA) of China, which has been accepted [1] - The approval of the IND application allows the data from the completed or ongoing Phase 1 clinical trials in healthy volunteers to be used to support the advancement of IBD indications to Phase 2 clinical development [1] - This IND application marks a significant milestone for SM17, expanding its treatment range from atopic dermatitis (AD) to IBD, which includes chronic and debilitating diseases such as Crohn's disease (CD) and ulcerative colitis (UC), addressing significant unmet medical needs [1] Group 2 - SM17 is a novel, globally first humanized IgG4-k monoclonal antibody designed to target the type II immune core "alarmin" molecule interleukin-25 (IL-25) receptor, regulating type II inflammatory responses [2] - By binding to the IL-25 receptor on the surface of type II innate lymphoid cells (ILC2s) and Th2 cells, SM17 can block the signaling cascade induced by IL-25, thereby inhibiting downstream cytokines IL-4, IL-5, and IL-13 [2] - This mechanism positions SM17 as a promising candidate for treating UC, where IL-25 plays a pro-inflammatory role, and it also offers dual potential benefits in CD by regulating Th17-driven inflammation and exerting anti-fibrotic effects, which may help improve complications such as intestinal strictures and fistulas [2]

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。 SM17新藥研究申請獲國家藥品監督管理局藥品審評中心受理 茲提述中國抗體製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）所刊發 日 期 為 二 零 二 二 年 二 月 十 六 日 、 二 零 二 二 年 三 月 十 四 日 、 二 零 二 二 年 六 月 十 五 日 、 二 零 二 三 年 五 月 二 十 二 日 、 二 零 二 三 年 六 月 十 二 日 、 二 零 二 三 年 八 月 十 四 日、二零二三年九月十一日、二零二三年十一月二十七日、二零二四年六月十一 日、二零二五年四月七日及二零二五年十月十四日的過往公告，內容有關本集團 主要產品之一SM17研發進展。 本公司董事會（「董事會」）欣然宣佈，於二零二五年十二月十一日，一項SM17針對 炎 症性 腸病（「IBD」）的 新藥 研究 申 請（「IND」）， 已 提交 予中 國 ...

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11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: | 中國抗體製藥有限公司 | | | | 呈交日期: | 2025年12月4日 | | | | I. 法定/註冊股本變動 不適用 | | | | | 備註： | | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | | FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 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) | 03681 | 說明 | | 不適用 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | | ...

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10月31日 | 狀態: 新提交 | | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | 公司名稱: | 中國抗體製藥有限公司 | | | 呈交日期: | 2025年11月5日 | | | I. 法定/註冊股本變動 不適用 | | | | 備註： | | | | 中國抗體製藥有限公司是一間於香港註冊成立的公司，因此法定股本及面值的概念並不適用。 | | | FF301 第 1 頁 共 10 頁 v 1.1.1 | 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) | | 03681 | 說明 | 不適用 | | | | | | | | | 股份期權計劃詳情 | | 上月底結存的股份期權數 目 | 本月內變動 | | 本月底結 ...

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]