当前，PD-(L)1抑制剂行业正处于发展转折点。翰思艾泰（3378.HK）以颠覆性创新打破困局，凭借两 款重磅管线HX009、HX044的突破性进展，让CD47强势崛起，正式开启肿瘤免疫治疗的全新篇章。 业内人士指出，在CD47赛道从沉寂到爆发的历史性跨越中，翰思艾泰以前瞻性的机制探索、颠覆性的 分子设计、扎实亮眼的临床数据，构建起不可复制的核心竞争优势。两款重磅管线不仅有效攻克了传统 CD47疗法的毒性痛点，更开辟了免疫检查点联合靶向的全新治疗路径。 作为CD47新机制的开拓者与领航者，翰思艾泰跳出传统"别吃我"信号阻断的单一框架，深度解码CD47 在肿瘤免疫中的核心调控密码。最新顶尖研究证实，CD47不仅是固有免疫的抑制信号，更是驱动T细胞 耗竭、激活肿瘤调节T细胞（Treg）的关键适应性免疫检查点——其高表达与免疫治疗耐药直接相关， 这一重大发现为靶向药物研发点亮了全新航向，而翰思艾泰早已精准布局，抢占技术制高点。 翰思艾泰表示，未来，公司将持续深耕CD47新机制，加速推进更多创新药物的临床转化，以强大的管 线价值赋能行业发展，用顶尖科学力量攻克肿瘤治疗难关，书写免疫治疗的全新传奇。 公司产品HX009 ...

FF301 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 翰思艾泰生物醫藥科技（武漢）股份有限公司（「本公司」）的普通股（H股）於2025年12月23日（「上市日」）首次在香港聯合交易所有限公司(「聯交所」)主版上市，上述「上月底結存」的結 存是指本公司於上巿日的相關註冊股本。 因本公司是於中華人民共和國註冊成立的公司，「法定股本」之概念不適用於本公司，在上述「法定/註冊股本」部分顯示的資料是指本公司的已發行股本。 第 1 頁 共 10 頁 v 1.1.1 公司名稱: 翰思艾泰生物醫藥科技（武漢）股份有限公司（於中華人民共和國註冊成立的股份有限公司） 呈交日期: 2026年1月7日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 03378 | 說明 | H股 | | ...

Group 1 - The stock of Hansai Aitai-B (03378.HK) has dropped over 13%, reaching a new low of 15.05 HKD during trading, which is more than a 50% decline from its IPO price of 32 HKD [2] - As of the latest update, Hansai Aitai-B is trading at 15.06 HKD, with a trading volume of 17.4468 million HKD and a total market capitalization of 2.061 billion HKD [2]

Core Viewpoint - The stock of Hansai Aitai-B (03378) has dropped over 13%, reaching a new low of 15.05 HKD, which is more than a 50% decline from its IPO price of 32 HKD [1] Company Overview - Hansai Aitai is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with proprietary core technologies and extensive experience [1] - The company has three clinical-stage candidates in the oncology field and seven preclinical candidates under research [1] - The core product, HX009, is a self-developed dual-function antibody fusion protein targeting PD-1 (an immune checkpoint receptor) and SIRPα [1] Financial Performance - The company reported losses of 85.16 million HKD, 117 million HKD, and 87.44 million HKD for the first eight months of 2023, 2024, and 2025, respectively [1] - As of October 31, 2025, the company had cash and cash equivalents amounting to 133 million HKD, with total current liabilities of 220 million HKD [1]

Group 1 - The core viewpoint of the article highlights that Hansa Biopharma-B (03378) has seen a significant decline in its stock price, dropping over 13% and reaching a new low of 15.05 HKD, which is more than a 50% decrease from its IPO price of 32 HKD [1] - As of the report, the stock is down 13.4%, trading at 15.06 HKD, with a trading volume of 17.4468 million HKD and a total market capitalization of 2.061 billion HKD [1] - Hansa Biopharma is a biotechnology company specializing in structural biology, translational medicine, and clinical development, with three clinical-stage candidates in oncology and seven preclinical candidates in development [1] Group 2 - The company's core product, HX009, is a self-developed dual-function antibody fusion protein targeting PD-1 (an immune checkpoint receptor) and SIRPα [1] - It is noteworthy that none of Hansa Biopharma's pipeline products have achieved commercialization [1] - Financially, the company reported losses of 85.16 million HKD, 117 million HKD, and 87.438 million HKD for the first eight months of 2023, 2024, and 2025, respectively [1] - As of October 31, 2025, the company has cash and cash equivalents amounting to 133 million HKD, with total current liabilities of 220 million HKD [1]

Core Viewpoint - The recent IPO of Hansai Aitai, a Wuhan-based innovative drug development company, faced significant market rejection, with its stock price plummeting by 46.25% on the first day of trading, leading to a market capitalization of approximately 20 billion RMB, making it the largest case of a biotech stock breaking below its IPO price in Hong Kong this year [3][4][6]. Group 1: IPO and Market Performance - Hansai Aitai completed its IPO after three submissions to the Hong Kong Stock Exchange, raising a net amount of approximately 5.31 billion HKD [7][10]. - Despite a reported oversubscription of about 3000 times during the public offering phase, the stock opened significantly lower than its issue price of 32 HKD, indicating a severe market correction [4][6]. - The company’s market debut has raised questions about the valuation and investor confidence in a company that is still in the high-investment, no-revenue stage of drug development [7][11]. Group 2: Financial Performance and Funding - The company has not yet commercialized any products, with its revenue primarily derived from licensing fees related to previous asset transfers [12][15]. - Financial data shows that the company’s research and development expenses increased from 46.66 million RMB in 2023 to 74.72 million RMB in 2024, while administrative expenses surged from 17.22 million RMB to 46.19 million RMB during the same period [17][19]. - The company’s income from other sources, including government grants and interest income, has been minimal, with total other income reported at 6.66 million RMB in 2023 and 7.68 million RMB in 2024 [19]. Group 3: Product Development Challenges - Hansai Aitai's core product, HX009, targets challenging pathways in cancer treatment, specifically late-stage melanoma and cholangiocarcinoma, but is still in the early clinical trial phases [20][24]. - The company faces significant hurdles in meeting its financing obligations, as it must submit new drug applications by the end of 2026 to avoid triggering redemption rights for investors [23][24]. - The lack of substantial clinical data and the high failure rate associated with the targeted pathways raise concerns about the feasibility of advancing its products to market [25][26]. Group 4: Corporate Governance and Related Transactions - The company has engaged in related party transactions with entities controlled by its founder, which raises questions about governance and financial transparency [27]. - High executive compensation has been noted, with significant salaries paid to top management despite the absence of commercialized products [28]. - The reliance on related companies for critical services and testing further complicates the operational landscape for Hansai Aitai [27]. Group 5: Industry Outlook - The biopharmaceutical sector's value ultimately hinges on clinical breakthroughs and commercialization capabilities, suggesting that reliance on capital market operations without solid R&D foundations may not sustain long-term growth [29]. - The future trajectory of Hansai Aitai remains uncertain, with ongoing monitoring required to assess its ability to navigate these challenges [30].

Core Viewpoint - Hansai Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, raising a total of HKD 586 million with an issue price of HKD 32 per share, enhancing its market capitalization to nearly HKD 4.4 billion [1] Company Overview - Established in 2014, the company focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases [1] - Currently, the company has a pipeline of 10 candidate drugs, with 3 in clinical stages and 7 in preclinical stages [1] Key Product Information - The core product, HX009, is a bispecific antibody fusion protein targeting both CD47 and PD-1, addressing indications such as melanoma and colorectal cancer [1] - HX009 is leading globally in clinical trial progress among similar products, having completed Phase I clinical trials in China and Australia, and is advancing multiple Phase II clinical trials in China [1] Market Impact - The successful listing on the main board of the Hong Kong Stock Exchange is expected to significantly enhance the company's industry influence, promote its brand globally, and facilitate more standardized and transparent corporate governance [1]

Core Viewpoint - The article discusses a fraudulent scheme involving a prominent figure in the pharmaceutical industry, referred to as "Kris.Z" or 杨泽康, who exploited trust to mislead investors into participating in a stock that subsequently plummeted in value, resulting in significant financial losses for retail investors [1][24]. Group 1: Fraud Mechanism - The fraud was orchestrated by leveraging the trust built over years and the influencer's status in the pharmaceutical sector, promising high returns and low risks to lure investors into the scheme [8][30]. - Investors were misled with false assurances of market stability and potential gains, while the actual market conditions indicated an impending decline in the stock price of 翰思艾泰-B (03378) [30][39]. - The scheme involved a profit-sharing model where investors were promised a 55% return, creating an illusion of safety and profitability [30][39]. Group 2: Market Reaction and Consequences - During the initial trading phase, the stock only dropped by 10%, which was used to maintain investor confidence while insiders sold off their shares [11][33]. - Once the stock had fallen by 30%, the perpetrator claimed that there were no guarantees, leaving investors to fend for themselves [13][35]. - Post-event discussions revealed attempts to deflect responsibility, with claims that investors were solely responsible for their losses and that a safety net had existed but required further investment [15][37]. Group 3: Investor Impact - One investor reported a loss of 1.85 million, highlighting the severe financial impact of the scheme on individual investors [1][24]. - The article serves as a cautionary tale for retail investors, emphasizing the importance of due diligence and skepticism towards high-return promises from influential figures [1][24].

Core Viewpoint - The Hong Kong IPO market for biotech companies has experienced extreme differentiation, with Baoyi Pharmaceutical achieving a significant surge in stock price while Huasheng Biotechnology and Hansai Aitai faced substantial declines, reflecting a shift in investor sentiment and valuation criteria in the sector [1][2][3]. Market Overview - The Hong Kong biotech IPO market in 2025 showed a "hot then cold" trend, with the first half benefiting from global market recovery and supportive policies, leading to significant first-day gains for new listings [2][3]. - December marked a turning point, with Baoyi Pharmaceutical's listing on December 10 serving as a watershed moment, followed by a sharp decline in the stock prices of Huasheng Biotechnology and Hansai Aitai shortly thereafter [3][4]. Market Shift Factors - The extreme differentiation in stock performance is attributed to multiple pressures in the Hong Kong IPO market, including stricter regulatory requirements and a significant increase in the number of new listings, leading to a higher rate of stock price declines [5][6]. - The biotech sector is facing valuation pressure as previous high valuations are reassessed against fundamental performance, with investors focusing on pipeline certainty and commercial viability [6]. Pipeline Comparison - Baoyi Pharmaceutical's "pyramid" pipeline strategy balances certainty and growth, focusing on clinically validated products and innovative therapies, while Huasheng Biotechnology and Hansai Aitai struggle with slow clinical progress and high uncertainty [7][10][12]. - Baoyi's pipeline includes products like SJ02 and KJ017, which have clear market potential and established clinical pathways, contrasting with Huasheng's limited and delayed pipeline [7][12]. Financial Health - Baoyi Pharmaceutical has demonstrated initial self-sustaining revenue capabilities, with significant revenue growth driven by commercialized products, while Hansai Aitai and Huasheng Biotechnology lack main business income and face escalating losses [15][18][20]. - Baoyi's financial position is bolstered by a strong cash reserve and successful fundraising, while Hansai Aitai and Huasheng Biotechnology are at risk of operational disruption due to cash flow constraints [17][19][21]. Commercialization Potential - Baoyi Pharmaceutical's products target large and growing markets, supported by strong partnerships, enhancing its commercial viability [22][23]. - In contrast, Hansai Aitai and Huasheng Biotechnology face significant challenges in commercializing their products due to intense competition and limited market acceptance [24][25]. Valuation Logic Shift - The valuation logic in the biotech sector has shifted from speculative "story-driven" assessments to a more rational "value-driven" approach, emphasizing pipeline certainty and financial sustainability [26][27][28]. - Baoyi Pharmaceutical's success is attributed to its clear commercial pathways and financial health, while Huasheng and Hansai Aitai's struggles highlight the risks of lacking fundamental support [28][30]. Investor Sentiment - The differentiation in stock performance reflects a broader trend of investors moving towards value-based assessments, focusing on core competencies and sustainable business models [31][32]. - The market is expected to continue favoring companies with strong fundamentals, while those lacking such support may face increasing scrutiny and potential exclusion from investor interest [32].

Core Viewpoint - The company Hansai Aitai-B (03378) has received approval from the National Medical Products Administration of China to conduct clinical trials for its innovative drug HX111, which is a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1][4]. Group 1: Stock Performance - The stock price of Hansai Aitai-B increased by nearly 6% during trading, with a current price of 17.60 HKD, reflecting a 2.33% rise and a trading volume of 16.8885 million HKD [1][4]. Group 2: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, with preclinical studies indicating that OX40 is overexpressed in several malignant tumors compared to normal tissues, making it a suitable target for ADC [1][4]. - HX111 is the third first-in-class molecule to advance to clinical development, following the company's previous dual-specific antibody therapies HX009 and HX044 [1][4]. - The company aims to continue its efforts in clinical development to bring more innovative first-in-class drugs to market [1][4].