Core Viewpoint - The report from Xingzheng International initiates coverage on InnoCare Pharma (09606) with a "Buy" rating, highlighting its focus on the ADC field and strategic collaborations with leading global pharmaceutical companies like BioNTech to expedite clinical development globally [1] Recent Events - The company will host a R&D day on October 23, 2025, to present recent advancements in its ADC product pipeline and future directions [2] - BioNTech will hold its R&D day on November 11, 2025, showcasing InnoCare's original ADC pipeline in combination with immune antibodies like PD-L1/VEGF [2] - The clinical phase 2a of the autoimmune ADC pipeline DB-2304 (BDCA2 ADC) for systemic lupus erythematosus has completed its first patient dosing [2] - Results from the single-dose escalation phase of DB-2304 will be presented at the AIC 2025 conference, and data for DB-1310 targeting HR+/HER2- breast cancer will be disclosed at the SABCS 2025 [2] Global Clinical Progress - The BLA submission for DB-1303 (HER2 ADC) targeting HER2+ endometrial cancer is expected in 2026, with ongoing phase 3 trials for HR+/HER2 low-expressing breast cancer and plans for a BLA submission in China by the end of 2025 [3] - DB-1311 (B7H3 ADC) is currently in a global phase 2 basket trial for various solid tumors, with potential frontline treatment opportunities for SCLC through combination with PD-L1/VEGF dual antibodies [3] - The ADC pipeline in collaboration with BioNTech opens new market opportunities for ADC combination therapies, while DB-2304 shows promising tolerability and pharmacokinetic characteristics, positioning it as a potential first-in-class ADC drug in the autoimmune field [3]

Core Viewpoint - The report from Xingzheng International initiates coverage on Ying'en Bio-B (09606) with a "Buy" rating, highlighting the company's focus on the ADC sector and its strategic collaborations with leading global pharmaceutical companies like BioNTech to accelerate clinical development globally [1] Recent Events - The company will host a R&D day on October 23, 2025, to present recent advancements in its ADC product pipeline and future directions [2] - BioNTech will hold its R&D day on November 11, 2025, showcasing clinical plans for Ying'en Bio's original ADC pipeline in combination with immune antibodies such as PD-L1/VEGF [2] - The clinical phase 2a portion of the DB-2304 (BDCA2ADC) for systemic lupus erythematosus has completed its first patient dosing [2] - Results from the single-dose escalation phase of DB-2304 were selected for oral presentation at the AIC2025 conference [2] - The company plans to present global phase 1/2a data for the DB-1310 HER3ADC pipeline at the SABCS2025 [2] Global Clinical Progress of ADC Pipeline - The BLA for DB-1303 (HER2ADC) targeting HER2+ endometrial cancer is expected to be submitted in the U.S. in 2026, with ongoing global phase 3 trials for HR+/HER2 low-expressing breast cancer [3] - The company aims to submit the Chinese BLA for this indication by the end of 2025 [3] - DB-1311 (B7H3ADC) is currently in a global phase 2 basket trial for various solid tumors, including SCLC and CRPC, with potential frontline treatment opportunities being explored [3] - The collaboration with BioNTech on PD-L1/VEGF dual antibodies opens up future market opportunities for ADC combination therapies [3] - The clinical progress of the self-immune ADC pipeline DB-2304 has shown good tolerability and pharmacokinetic characteristics, positioning it as a potential first-in-class ADC drug in the autoimmune field [3]

映恩生物首席科学官兼美国总经理邱杨博士表示，DB-2304作为全球首个进入临床的靶向BDCA2的免疫 调节ADC，其Ⅰ期健康受试者数据验证了我们基于生物学的药物设计理念，我们将加快推进该创新药 在SLE及CLE患者中的临床开发进度，期待早日为自身免疫疾病治疗带来ADC新突破。 消息面上，2025年第53界秋季免疫学会议(AIC2025)在美国芝加哥举办，映恩生物在会议上以口头报告 形式公布了首创BDCA2靶向免疫调节抗体偶联药物(ADC)DB-2304的Ⅰ期随机对照研究数据。研究结果 显示，DB-2304在健康受试者中整体安全耐受性良好，药代动力学(PK)特征呈线性，并可有效结合靶 点，验证了其药理机制。 映恩生物-B(09606)早盘涨近9%，截至发稿，涨7.17%，报349.6港元，成交额1.18亿港元。 ...

智通财经APP获悉，映恩生物-B(09606)早盘涨近9%，截至发稿，涨7.17%，报349.6港元，成交额1.18亿 港元。 映恩生物首席科学官兼美国总经理邱杨博士表示，DB-2304作为全球首个进入临床的靶向BDCA2的免疫 调节ADC，其Ⅰ期健康受试者数据验证了我们基于生物学的药物设计理念，我们将加快推进该创新药 在SLE及CLE患者中的临床开发进度，期待早日为自身免疫疾病治疗带来ADC新突破。 消息面上，2025年第53界秋季免疫学会议（AIC 2025）在美国芝加哥举办，映恩生物在会议上以口头报 告形式公布了首创BDCA2靶向免疫调节抗体偶联药物（ADC）DB-2304的Ⅰ期随机对照研究数据。研 究结果显示，DB-2304在健康受试者中整体安全耐受性良好，药代动力学（PK）特征呈线性，并可有效 结合靶点，验证了其药理机制。 ...

Core Insights - The company, Ying'en Biotech, recently held a R&D day to update on several pipeline developments and progress in their clinical trials [1][2]. Group 1: Pipeline Developments - Ying'en Biotech is advancing in IO 2.0 combination therapies, with three ADCs (DB-1303, DB-1311, DB-1305) partnered with BioNTech, currently in four global clinical trials, all of which have completed the first patient enrollment [1]. - DB-1311 is exploring treatment potential in small cell and non-small cell lung cancer under various conditions, while DB-1303 is covering different HER2 expression levels in breast cancer [2]. - DB-1305 is progressing the fastest, with early efficacy and safety data expected to be released at the 2025 AACR, showing a low overlapping toxicity rate of only 4.5% among 67 patients with advanced/metastatic solid tumors [2]. Group 2: New Drug Candidates - The second dual-antibody ADC, DB-1419, has been introduced, utilizing an innovative target combination and a self-developed toxin, P1003, with a DAR of 8, showing superior tumor suppression effects in preclinical studies compared to B7-H3 ADC [2]. - DB-1317, a new member of the DITAC platform, shows significant drug potential in gastrointestinal tumors, with ADAM9 expression being 20 times higher than HER2 and 3 times higher than CLDN18.2 in these cancers [3]. Group 3: New Toxin Mechanism - The new toxin DUP5 from the DUPAC platform has been revealed to block the translation initiation of oncogenic mRNA through its action on the eIF4F complex, demonstrating broad-spectrum anti-tumor activity [3]. Group 4: Financial Outlook - Due to the company's extensive layout and leadership in IO 2.0 combinations, along with the continuous introduction of new molecules, the target price has been raised to 496.89 HKD based on DCF valuation, maintaining a "buy" rating [3].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price raised to HKD 496.89 [6][4]. Core Insights - The company is leading in the development of IO 2.0 combination therapies, with three ADC assets (DB-1303, DB-1311, and DB-1305) already initiating four global clinical studies in collaboration with BioNTech [2][12]. - The ADCs are designed to explore various cancer types, including lung cancer and breast cancer, showcasing the potential for broad application in oncology [2][21][27]. - The report highlights the safety profile of the ADCs, particularly DB-1305, which has shown low rates of overlapping toxicity and a drug discontinuation rate of only 4.5% in clinical trials [23][24]. Summary by Sections Section 1: Embracing ADC Combination IO2.0 - The company has initiated four clinical studies for its ADCs in collaboration with BioNTech, focusing on the combination of ADCs with PD-L1/VEGF bispecific antibodies [2][12]. - DB-1311 is exploring various lung cancer types, while DB-1303 is targeting different HER2 expression levels in breast cancer [17][21]. - The ADCs are positioned to expand the treatment landscape for multiple cancer types, leveraging the synergistic effects of IO 2.0 [12][14]. Section 2: DB-1419 - A Novel PD-L1 x B7-H3 ADC - DB-1419 is a newly introduced ADC utilizing a unique "2+2" antibody design, showing superior tumor suppression effects in preclinical studies compared to existing B7-H3 ADCs [27][28]. - The ADC is currently undergoing global I/II phase clinical trials, with data expected in 2026 [28]. Section 3: DB-1317 - ADAM9 ADC for Gastrointestinal Tumors - DB-1317 targets ADAM9, which is highly expressed in various gastrointestinal cancers, demonstrating significant therapeutic potential [31][32]. - The ADC's design allows for targeted delivery of cytotoxic agents, enhancing its efficacy against tumors with high ADAM9 expression [31][32]. Section 4: DUPAC Platform and New Mechanisms - The DUPAC platform introduces innovative payloads aimed at overcoming resistance to existing therapies, with DUP5 showing broad anti-tumor activity [35][40]. - DUP5 operates through a unique mechanism that inhibits mRNA translation, allowing it to target both proliferating and non-dividing cancer cells [35][40].

Market Performance - The Hang Seng Index increased by 1.26% this week, closing at 26,572.46 points, while the Tech Index decreased by 0.42% to 5,812.80 points, and the National Enterprises Index rose by 1.41% to 9,397.96 points [2][4]. Market Dynamics - The fluctuations in the Hong Kong stock market are closely related to external environments, particularly the impact of the U.S. government shutdown, which temporarily locked nearly one trillion dollars in liquidity, raising the cost of dollar funds and pressuring risk assets like U.S. and Hong Kong stocks [4]. - A recent report from Western Securities suggests that the end of the U.S. government shutdown may release previously "frozen" dollar liquidity, potentially leading to a liquidity-driven rally in the Hong Kong stock market [4]. Capital Inflows - Southbound capital has provided strong support, with net purchases through the Stock Connect exceeding HKD 1.3 trillion this year, totaling over HKD 5 trillion, indicating a shift towards a "semi-onshore market" where domestic capital plays a more significant role in pricing [4]. Sector Performance - Pharmaceutical stocks have seen renewed interest, with notable gains: - Gilead Sciences (01672.HK) up 45.40% - Clover Biopharmaceuticals (02197.HK) up 29.95% - Yummy (02589.HK) up 18.81% - The positive performance is attributed to strong Q3 results in innovative drugs and life sciences sectors [5]. - Other notable performers include: - HuShang Ayi (02589.HK) up 31.44% due to a new ten-year H-share incentive plan and reaching over 10,739 stores [5]. - Lee & Man Paper (00746.HK) up 17.37% benefiting from rising paper prices [5]. - Conversely, companies like Sanhua Intelligent Control (02050.HK) and Legend Holdings (06683.HK) faced declines of 10.93% and 19.82%, respectively, due to market risk aversion and concerns over equity dilution from a recent share placement [5]. Gold and Automotive Sectors - Gold stocks weakened following hawkish comments from Federal Reserve officials, with China Gold International (02099.HK) down 3.94% and Zijin Mining (02899.HK) down 2.94% [6][7]. - The automotive sector also faced declines, with Xpeng Motors (09868.HK) down 6.80% amid a drop in retail sales of passenger cars by 19% year-on-year for the first nine days of November [10][11]. Brokerage and Semiconductor Stocks - Chinese brokerage stocks adjusted, with major firms like GF Securities (01776.HK) and China Galaxy (06881.HK) experiencing declines due to a significant drop in new account openings [13]. - Semiconductor stocks also fell, influenced by a broader sell-off in U.S. tech stocks, with Shanghai Fudan (01385.HK) down 5.92% and SMIC (00981.HK) down 2.78% [14][16]. Individual Stock Movements - Lehua Entertainment (02306.HK) rose nearly 8% amid speculation regarding a contract renewal with a prominent artist [18]. - Zhonghui Biopharmaceuticals (02627.HK) increased by over 6% after announcing the initiation of Phase I clinical trials for its flu vaccines [19].

Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]

Group 1 - Shimai Pharmaceutical plans to list on the Hong Kong Stock Exchange, having submitted its application with Huatai International as the sole sponsor [1] - Established in 2017, Shimai is a pioneer in next-generation T-cell engagers (TCE) aimed at utilizing the human immune system to combat cancer, with four self-developed clinical-stage candidates [1] - The company's core technology, the masking TCE, is designed for selective activation in tumors, focusing on solid tumors, which aligns with the growth trend in the TCE sector [1] Group 2 - Gilead Sciences announced the entry of its new generation of drugs ASC36 and ASC35 into clinical development, targeting obesity with a planned FDA submission in Q2 2026 [2] - ASC36 and ASC35 are proprietary long-acting combination formulations with superior physicochemical stability, designed to avoid aggregation and precipitation [2] - ASC36 is positioned as a cornerstone therapy for treating metabolic diseases, potentially offering better efficacy and tolerability compared to GLP-1 therapies [2] Group 3 - InnoCare Pharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors as an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of DB-1418 aims to address treatment bottlenecks in resistant solid tumors, enhancing the company's pipeline competitiveness [3] Group 4 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by the sales growth of its core product, BTK inhibitor Orelabrutinib [4] - Orelabrutinib's revenue increased by 45.8% year-on-year, surpassing last year's total revenue, while the company's losses narrowed by 74.8% to 70 million yuan [4] - The revenue growth and reduced losses indicate a potential profitability turning point, which may accelerate the advancement of the innovation pipeline and strengthen the company's position in the BTK field [4]

每经AI快讯，映恩生物-B(09606.HK)再涨超8%，截至发稿，涨7.36%，报329.6港元，成交额6.58亿港 元。 ...