随着一年即将进入尾声，回望今年港股市场，创新药板块表现最为亮眼。富途行情数据显示，截至12月 9日，生物医药B类股年内涨幅达119%，51只成分股中涨幅超过1倍的多达25只。 近期广发证券发布研报称，CDMO行业业绩已触底回升，基于新签订单及新分子的旺盛研发需求，各公 司2026年有望延续业绩优秀增长的趋势。其同时看好基本面强劲产能优势显著伴随行业复苏及新分子业 务高景气度受益的企业，以及伴随产能利用率提升带动盈利能力改善利润弹性空间大的公司。 ADC被誉为"生物导弹"，其生产工艺之复杂、技术门槛之高，对企业的商业化生产能力及质量体系提出 了相当高的要求。在乐普生物这一项目中面临着供应链整合、时间紧迫及合规上市等多重挑战，东曜药 业能够助力客户突破重围，正是得益于其构建的三大核心能力矩阵。 首先，作为国内少有的ADC一站式CDMO开发企业，东曜药业在此次项目中凭借其预先构建的一站式 ADC服务平台，提供了从单抗原料药生产、ADC 偶联原液制备到制剂生产的端到端覆盖，实现了全流 程的无缝衔接与高效协同，为项目的成功推进奠定了坚实基础。 遵循这一方向笔者留意到东曜药业近期利好不断。此前，公司成功助力合作伙伴乐普生 ...

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]

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - Short-term performance is under pressure, but international expansion of innovative products opens up long-term growth opportunities [5] - The company reported a significant decline in revenue and net profit in the first half of 2025, primarily due to reduced demand in its large infusion and intermediate products business [7] - The company has a leading global ADC (Antibody-Drug Conjugate) R&D platform, with substantial potential in overseas markets [7] - The company has successfully transitioned from generic to innovative drug development, with significant R&D investments expected to yield returns [7] Financial Performance Summary - In the first half of 2025, the company achieved revenue of 9.08 billion (RMB), a year-on-year decrease of 23.2%, and a net profit of 1.0 billion (RMB), down 44.4% [7] - The revenue forecast for 2025 is 19.376 billion (RMB), with a year-on-year growth rate of -11.17% [6] - The projected net profit for 2025 is 2.417 billion (RMB), with a year-on-year decline of 17.67% [6] - The company’s gross margin for the first half of 2025 was 49.76%, a decrease of 4.07 percentage points year-on-year [7] - The company’s R&D expenses as a percentage of revenue increased to 11.54%, up 2.42 percentage points year-on-year [7] Business Segment Performance - Revenue from large infusion products in the first half of 2025 was 3.75 billion (RMB), a decline of 19.65% year-on-year [7] - Revenue from non-infusion pharmaceuticals was 1.955 billion (RMB), down 3.18% year-on-year [7] - Revenue from antibiotic intermediates and raw materials was 2.282 billion (RMB), a decrease of 30.29% year-on-year [7] - Overseas revenue was 1.13 billion (RMB), down 39.69% year-on-year, mainly due to a decline in overseas licensing income [7] Future Outlook - The company is expected to see a recovery in revenue from its two main business segments in 2026 [7] - The projected net profit for 2026 is 2.943 billion (RMB), with a year-on-year growth rate of 21.74% [6] - The company is positioned to become a leading global pharmaceutical enterprise, with significant growth potential in innovative drugs [7]

Core Viewpoint - Lyon's report indicates that Rongchang Biologics (09995) achieved a 39.1% year-on-year increase in sales for the second quarter, which, while below market expectations, exceeded the company's annual guidance [1] - The net loss narrowed by 54.7% year-on-year, outperforming market expectations [1] - The management maintains its annual sales guidance, anticipating over 30% year-on-year growth, and expects to achieve breakeven by 2026 [1] Financial Performance - Second quarter sales increased by 39.1% year-on-year [1] - Net loss reduced by 54.7% year-on-year [1] - Annual sales guidance remains unchanged, with expectations of over 30% growth [1] Business Development - The indications for RC18 and RC48 are gradually expanding [1] - The company's new immunotherapy (I/O) and ADC research and development pipeline is taking shape [1] Profit Forecast and Target Price - Profit forecasts for 2025, 2026, and 2027 have been raised by 79.6%, 106.9%, and 116.4% respectively [1] - Target price has been significantly increased from HKD 33.7 to HKD 103, while maintaining an "outperform" rating [1]

Core Viewpoint - The report from Credit Lyonnais indicates that Rongchang Biologics (09995) achieved a 39.1% year-on-year increase in sales for the second quarter, which, while below market expectations, exceeded the company's annual guidance [1]. Financial Performance - The net loss narrowed by 54.7% year-on-year, outperforming market expectations [1]. - The management maintained the annual sales guidance, projecting a year-on-year increase of over 30% [1]. Business Development - The indications for RC18 and RC48 are gradually expanding, and the company's new immunotherapy (I/O) and ADC research and development pipeline is taking shape [1]. - Credit Lyonnais has raised its net profit forecasts for 2025, 2026, and 2027 by 79.6%, 106.9%, and 116.4% respectively [1]. Target Price Adjustment - The target price has been significantly raised from HKD 33.7 to HKD 103, while maintaining an "outperform" rating [1].

Market Position and Growth Potential - Kanghong Pharmaceutical has established a leading position in the Chinese ophthalmic anti-VEGF market, competing against three major global brands [2] - The company has successfully navigated market challenges over the past decade, demonstrating confidence in continuing to outperform international competitors [2] - The incidence rates of the five major indications for anti-VEGF products are stable, suggesting that Kanghong's growth will align with the overall market trend [2] Research and Development Strategy - The company focuses on key therapeutic areas: ophthalmology, psychiatry/neuroscience, and oncology, with a diversified R&D system covering traditional Chinese medicine, antibody drugs, gene therapy (AAV), and small molecule drugs [3] - Kanghong is advancing multiple innovative projects, including the "Shu Gan Jie Yu Capsule" for anxiety disorders, which is currently in phase III clinical trials [3][7] - The company plans to disclose clinical data for its gene therapy products through international academic journals and conferences [4] Financial Outlook - For 2025, Kanghong anticipates a revenue growth of 5%-15% compared to 2024, with a similar net profit growth forecast [7] - The "Shu Gan Jie Yu Capsule" is expected to see double-digit growth in 2024, outpacing the overall antidepressant market [7] Competitive Landscape and Policy Impact - The competitive landscape for anti-VEGF products has intensified, with four innovative drugs and two biosimilars entering the market following successful negotiations with national health insurance [5] - Kanghong is adapting to national procurement policies, with a significant portion of its chemical drugs selected for national procurement [4] Talent and Collaboration - The company emphasizes talent acquisition and development to support its R&D needs, particularly in gene therapy and advanced drug delivery systems [6] - External collaborations are viewed as a core strategy for long-term value growth, focusing on complementary technologies and commercial synergies [6]