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 ...

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 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].

Group 1 - Hansi Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange on December 23, becoming the 71st listed company in the Optics Valley region [1] - The IPO involved a global offering of 18.321 million shares at an issue price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion [1] - Hansi Aitai focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases, with a pipeline of 10 candidate drugs, including 3 in clinical stages and 7 in preclinical stages [1] Group 2 - The founder of Hansi Aitai, Zhang Faming, is a professor and doctoral supervisor at Wuhan University School of Pharmacy, and has been an entrepreneur in the innovative drug field for 16 years [2] - The total number of listed companies in the Optics Valley region has reached 71, accounting for over 60% of the city's total and approximately one-third of the province's total [2] - In the life and health sector, there are currently 9 listed companies in the Optics Valley, with 6 companies undergoing listing review and 19 companies starting IPO counseling [2]

Group 1 - Han's Biopharma (3378.HK) listed on the Hong Kong Stock Exchange on December 23, raising a total of HKD 586 million by offering 18.32 million shares at HKD 32 per share, with a market capitalization of nearly HKD 4.4 billion [1] - Following the IPO, the stock price fell significantly, closing at HKD 17.2 per share, representing a decline of 46.25% and a total market value of HKD 2.343 billion [1] - The company, founded in 2014, focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases, with a pipeline of 10 candidate drugs, including 3 in clinical stages and 7 in preclinical stages [1] Group 2 - The core product, HX009, is a self-developed dual-function antibody fusion protein that has completed Phase I clinical trials in Australia and China, and is currently undergoing Phase Ib/I/IIa clinical trials for advanced melanoma, relapsed/refractory EBV-positive non-Hodgkin lymphoma, and advanced biliary cancer in China [1] - The company also has two other main clinical-stage products: HX301, a multi-target kinase inhibitor in Phase II trials for glioblastoma, and HX044, a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein in Phase I/IIa trials for advanced solid tumors [2] - The founder, Zhang Faming, is a professor and doctoral supervisor at Wuhan University, with a history of entrepreneurship in the innovative drug sector, having established multiple companies in the Wuhan East Lake High-tech Zone, which has a significant number of listed companies in the life and health sector [2]

Core Viewpoint - Hansa Biopharma-B (03378.HK) has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials for its innovative drug, HX111, which is a first-in-class (FIC) OX40-targeted antibody-drug conjugate (ADC) [1] Group 1: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, which shows overexpression in several malignancies, including certain lymphomas, compared to normal tissues, making it a suitable target for ADC therapies [1] - Preclinical studies indicate that OX40 is a tumor-associated antigen (TAA) and is overexpressed in regulatory T cells (Treg) within the tumor microenvironment (TME), which are known to suppress anti-tumor immunity [1] - The mechanism of action (MOA) for HX111 involves the elimination of Tregs, representing a novel approach in cancer immunotherapy with potential applications across various cancers [1] Group 2: Company Strategy - HX111 is the third first-in-class molecule to advance to clinical development following the company's previous dual-specific antibody (BsAb) therapies, HX009 and HX044 [1] - The company aims to continue its efforts in clinical development to bring more innovative FIC drugs to market [1]

Core Viewpoint - The recent IPOs of two biotech companies, Huazhang Biotechnology and Hansai Aitai, faced significant declines on their debut trading days, indicating a bearish sentiment in the market for innovative drug companies, despite their initial hype and strong subscription rates [1][3][9]. Group 1: IPO Performance - Huazhang Biotechnology's stock fell nearly 30% on its first trading day, while Hansai Aitai's stock opened at 28.9 HKD, down 9.69% from its issue price of 32 HKD, and closed at 17.20 HKD, marking a 46.25% drop [1][3]. - Hansai Aitai's stock experienced a maximum intraday decline of 46.25%, failing to recover significantly by the end of the trading day [1][3]. Group 2: Subscription and Issuance Details - Hansai Aitai's global offering consisted of 18.32 million shares, with a public offering that was oversubscribed by 3074.09 times, resulting in a final allocation of 183.21 million shares, approximately 10% of the total offering [4][5]. - The final issue price was set at the upper limit of the range at 32 HKD, raising a net amount of 531 million HKD [5][6]. Group 3: Market Sentiment and Strategy - Both companies were initially viewed as "big meat" in the market due to their innovative drug offerings, yet their first-day performances fell short of expectations, reflecting a potential shift in investor sentiment towards unprofitable biotech firms [3][9]. - The adoption of the "Mechanism B" strategy, which favors institutional and cornerstone investors, did not yield the expected price stability for either company, as evidenced by their poor debut performances [9][10]. Group 4: Financial Performance and Valuation - Hansai Aitai reported losses of 85.16 million HKD, 117 million HKD, and 87.43 million HKD for the years 2023, 2024, and the first eight months of 2025, respectively [14]. - The company's post-IPO valuation reached 43.52 billion HKD, significantly higher than its pre-IPO valuation of approximately 16.15 billion HKD, raising concerns about its market valuation relative to industry averages [14].