金融界6月25日消息，上证指数低开高走，中证沪深港生物科技主题指数 (沪深港生物科技主题， 932245)报1352.64点。 资料显示，指数样本每半年调整一次，样本调整实施时间分别为每年6月和12月的第二个星期五的下一 交易日。权重因子随样本定期调整而调整，调整时间与指数样本定期调整实施时间相同。在下一个定期 调整日前，权重因子一般固定不变。当特殊情况下将对指数进行临时调整。当样本退市时，将其从指数 样本中剔除。样本公司发生收购、合并、分拆等情形的处理，参照计算与维护细则处理。当沪股通、深 股通和港股通证券范围发生变动导致样本不再满足互联互通资格时，指数将相应调整。 本文源自：金融界 作者：行情君 从指数持仓来看，中证沪深港生物科技主题指数十大权重分别为：恒瑞医药（12.02%）、百济神州 （10.82%）、药明康德（8.63%）、迈瑞医疗（7.04%）、信达生物（6.24%）、药明生物（4.88%）、 康方生物（3.31%）、石药集团（3.04%）、中国生物制药（2.78%）、三生制药（2.05%）。 从中证沪深港生物科技主题指数持仓的市场板块来看，香港证券交易所占比45.80%、上海证券交易所 占比33 ...

Core Insights - Innovent Biologics announced positive Phase 3 clinical study results for mazdutide, a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, in treating type 2 diabetes (T2D) in Chinese adults, demonstrating significant efficacy in glycemic control and weight loss [1][8] Clinical Study Details - The DREAMS-1 study enrolled 319 Chinese participants with T2D inadequately controlled by diet and exercise, with a mean age of 50.4 years and a mean baseline HbA1c of 8.24% [2] - Participants were randomized to receive either mazdutide 4 mg, mazdutide 6 mg, or placebo for 24 weeks, with the primary endpoint being the change in HbA1c from baseline to week 24 [2] Efficacy Results - Mazdutide achieved an HbA1c reduction of 2.15% after 24 weeks, with 68.6% and 87.4% of participants on mazdutide 4 mg and 6 mg, respectively, achieving HbA1c <7.0%, compared to 10.7% with placebo [3] - Weight reduction was also significant, with participants on mazdutide 4 mg and 6 mg showing a percentage change in body weight of -5.61% and -7.81%, respectively, compared to -1.26% with placebo [4] Cardiometabolic Improvements - Treatment with mazdutide led to significant improvements in multiple cardiometabolic risk factors, including fasting glucose, waist circumference, blood pressure, and lipid levels [5] Safety Profile - Mazdutide exhibited a favorable safety profile, with low incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation, primarily mild to moderate gastrointestinal symptoms [6][7] Market Context - China has a high incidence of T2D, with approximately 140 million adult patients, highlighting the urgent need for effective treatment options [8][9] - The treatment landscape for diabetes is shifting towards a patient-centered approach, integrating glycemic control, weight management, and cardiovascular risk factor management [8] Future Prospects - Mazdutide has two New Drug Applications (NDAs) under review by China's National Medical Products Administration (NMPA) for chronic weight management and glycemic control in adults with T2D [11][12] - Innovent is actively developing a next-generation pipeline in the cardiovascular and metabolic fields, aiming to meet public health needs [12]

Summary of the Conference Call for Innovent Biologics Company Overview - **Company**: Innovent Biologics - **Industry**: Innovative Pharmaceuticals Key Points and Arguments Industry Dynamics - The innovative drug sector is experiencing a rebound driven by changes in demand and policy, with Hong Kong's innovative drug sector valuations rising, albeit limited by profit growth [2][3] - The sector is at a historical low valuation, with recent data from the ASCO conference showcasing the global competitiveness of domestic innovative drug companies [3] Financial Performance - Innovent Biologics reported strong revenue performance, with projected revenue exceeding 8.2 billion yuan in 2024, representing a 40% year-on-year growth [2][6] - Q4 product revenue is expected to surpass 2 billion yuan, showing a 25% increase year-on-year [2][6] Product Pipeline and Commercialization - The company anticipates commercializing 14 products within the next one to two years, with several entering NDA and NMPA reviews or critical clinical studies [2][7] - Expected new revenue streams from products like IGF-1R and peptide I23P19 are projected to help achieve EBITDA breakeven by 2025, with domestic product revenue reaching 20 billion yuan by 2027 [2][7] Key Products and Innovations - The PD-1/IL-2 fusion protein IBI363 has shown significant efficacy in treating IO-resistant non-small cell lung cancer and third-line colorectal cancer, with global peak sales potential estimated at 10 billion USD [2][9][10] - The drug's design enhances efficacy while reducing toxicity, showing promising data in clinical trials [9][10] Market Opportunities - The GIP/GLP-1 dual receptor agonist, Masitide, is expected to be approved by 2025, providing a new growth avenue for the company [4][12] - Innovent's comprehensive layout in the metabolic field, including the P9 monoclonal antibody, is expected to drive sales growth [4][13] Competitive Landscape - The company is well-positioned in the autoimmune sector with innovative drugs like IL-23 P19, which is anticipated to gain market approval soon [4][16] - The market for thyroid eye disease is significant, with approximately 4 million patients in China, and Innovent's IGF-1R antibody showing promising results [14] Valuation and Future Outlook - Innovent's projected revenue of 20 billion yuan by 2027 is seen as a target, with potential peak sales reaching 30 billion yuan based on ongoing clinical developments [8] - The company is suitable for DCF valuation rather than PS, as its early-stage assets have not been fully assessed [8] - The future outlook remains optimistic, with numerous catalysts expected from clinical data releases in the coming years [18] Conclusion - Innovent Biologics is positioned as a strong candidate for medium to long-term investment, supported by robust revenue growth, a promising product pipeline, and favorable market dynamics [18]

Investment Rating - The report assigns an "Overweight" (OW) rating to Innovent, Akeso, and Kelun Biotech, indicating an expectation that these stocks will outperform the average total return of their coverage universe [4][7]. Core Insights - Innovent has shown strong investor interest, with a recent stock increase of approximately 3% following a share sale by Lilly Asia Ventures. The company achieved its first-ever non-IFRS positive profit and EBITDA in 2024, and this trend is expected to continue into 2025 and beyond. Innovent is anticipated to secure an outlicensing deal for IBI363, which holds significant value in the immuno-oncology therapy space [4]. - Akeso's share price rose by 10% on June 10, attributed to comments from its U.S. partner, Summit, regarding avoiding a cash raise and manufacturing Ivonescimab in-house. Summit plans to recruit participants for global trials from multiple regions, including China, the U.S., and the EU. The BLA filing strategy for HARMONi is still under discussion [4]. - Kelun Biotech completed an equity raise and does not require additional cash due to solid reserves. Promising ASCO data for Sac-TMT in treating triple-negative breast cancer and non-squamous non-small cell lung cancer indicates a higher probability of success in Phase 3 trials. The domestic Phase 3 trial is enrolling patients rapidly, with potential for an interim analysis this year [4][5]. Summary by Company Innovent - Innovent's stock increased by ~3% after a secondary share placement by Lilly Asia Ventures, which still holds a ~2% stake. The company achieved its first non-IFRS positive profit and EBITDA in 2024, with expectations for continued growth in 2025. Anticipated catalysts include an outlicensing deal for IBI363 [4][5]. Akeso - Akeso's share price increased by 10% following positive comments from Summit, its U.S. partner. Summit is working on in-house manufacturing of Ivonescimab and plans to recruit trial participants from various regions. The BLA filing strategy for HARMONi is still being evaluated [4][5]. Kelun Biotech - Kelun Biotech completed an equity raise and has solid cash reserves. Promising data for Sac-TMT in treating specific cancers suggests a high probability of success in upcoming trials. The company is rapidly enrolling patients for a domestic Phase 3 trial, with potential for an interim analysis this year [4][5].

Investment Rating - The report maintains an "OUTPERFORM" rating for Innovent Biologics with a target price of HK$90.10, up from a previous target of HK$62.50 [2][10]. Core Insights - Innovent Biologics showcased its strong oncology R&D capabilities at the 2025 ASCO Annual Meeting, with eight studies selected for oral presentation, highlighting the efficacy and safety of IBI363 and IBI343 in various cancer types [3][15]. - The data presented for IBI363 in IO-pretreated advanced non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) supports its potential as a backbone therapy for future immuno-oncology treatments [4][16]. Financial Summary - Revenue projections for Innovent Biologics are set at RMB 11.86 billion for 2025, with a growth rate of 26% compared to the previous year [10][13]. - The company is expected to turn profitable in 2025, achieving a net profit of RMB 384 million, with further growth anticipated in subsequent years [10][13]. Clinical Data Highlights - IBI363 monotherapy demonstrated a median progression-free survival (mPFS) of 9.3 months in advanced NSCLC patients, outperforming standard therapies [5][19]. - In patients with MSS-type colorectal cancer, IBI363 showed a median overall survival (mOS) of 16.1 months, significantly longer than the typical 9-10 months seen with current treatments [8][20]. - The efficacy of IBI363 in treating acral and mucosal melanoma was also notable, with a confirmed objective response rate (ORR) of 23.3% in IO-refractory patients [9][22]. Valuation and Estimates - The report employs a DCF model for valuation, estimating a share price of HK$90.10 based on projected cash flows from 2026 to 2037 [10][12]. - The gross profit margin is expected to remain high, around 84% in the coming years, indicating strong operational efficiency [10][13].

Group 1 - Morgan Stanley raised the target price for Innovent Biologics (01801.HK) from HKD 74 to HKD 84, maintaining an "Overweight" rating [1] - The increase in target price is attributed to upcoming catalysts and updates following the American Society of Clinical Oncology (ASCO) meeting [1] - The positive data on overall survival for IBI363 presented at the ASCO conference is expected to drive further stock performance [1] Group 2 - Morgan Stanley anticipates that the drug MaShidu will receive approval in China within 1 to 2 months, potentially providing additional stock options [1] - The sales forecast for IBI363 has been raised by approximately 95% post-ASCO meeting, along with an increase in pipeline valuation [1] - The firm holds a moderate sales expectation for MaShidu in 2025 [1]

Investment Rating - The report assigns a "Buy" rating to Innovent Biologics with a revised 12-month price target of HK$74.95, reflecting an upside potential of 15.2% from the current price of HK$65.05 [15][9]. Core Insights - Innovent Biologics has shown encouraging survival benefits for its drug IBI363 in various cancer indications, particularly in IO-treated squamous and adeno NSCLC, with improved overall response rate (ORR) and progression-free survival (PFS) data compared to previous reports [1][2][12]. - The risk-adjusted sales forecast for IBI363 has been raised to US$3.2 billion by 2035, up from US$1.4 billion, due to the addition of 2L adeno NSCLC and an increase in the probability of success (POS) for other indications [1][9]. - The report highlights the importance of randomized controlled trials (RCT) to further validate the long-term benefits of IBI363, especially in the context of its mechanism of action that enhances the immune environment [7][12]. Summary by Sections Clinical Data - The updated phase 1 data for IBI363 indicates a median PFS of 9.3 months for the high-dose cohort, an increase from 7.3 months previously reported, and a median overall survival (mOS) of 15.3 months, suggesting a strong conversion from PFS to OS [2][7]. - In adeno NSCLC, the median PFS was shorter at 5.6 months, but the overall survival data remains competitive, indicating potential lasting benefits post-disease progression [3][7]. Market Position and Valuation - Innovent Biologics is positioned as a leading biopharma company in China with a robust pipeline of over 30 assets, including the leading PD-1 inhibitor sintilimab [12]. - The report emphasizes that Innovent is undervalued at current levels, with a high market-implied weighted average cost of capital (WACC) that does not fully reflect its strong revenue potential and pipeline [12]. Future Outlook - The ongoing phase 1b/2 trial for IBI363 in combination with chemotherapy in the first-line setting is expected to generate further discussions regarding its competitive safety profile and efficacy [8][12]. - The report anticipates that the company will maintain its leading position in the biotech sector in China, supported by strong commercialization capabilities and collaborations with global partners [12].

信达生物 20250608 摘要 363 项目的数据表现优异。在混合组（剂量为 1~1.5 毫克）中，中位总生存期 （OS）达到 15.3 个月，而 12 个月 OS 率也显示出积极预期。鳞癌组数据显示， 该品种疗效在研品种中表现突出，中位无进展生存期（mPFS）达到 9.3 个月。 此外，高剂量组（3 毫克）的未来 OS 水平预期较高，这些数据表明 363 在非 Q&A 信达生物在创新药领域的最新进展是什么？ 信达生物近期在创新药领域取得了显著进展，特别是在 PD-1/CTLA-4 双抗 363 项目上。该项目目前在黑色素瘤、非小细胞肺癌和结直肠癌等适应症上积 累了大量数据，成功率较高。2025 年 1 月，信达生物与 Kakao 合作启动了黑 色素瘤的临床试验。363 项目作为 first in class 品种，其机制有效性和特异性 激活免疫系统的潜力得到了临床前研究和 ASCO 会议上的数据验证。 为什么 PD-1 类药物值得关注？ PD-1 类药物因其广泛的适应症拓展能力而备受关注，特别是在非小细胞肺癌 （NSCLC）中的应用。全球范围内，NSCLC 占据 PD-1 销售比例最高，大约 为 43%。 ...

Core Viewpoint - The Hong Kong innovative drug ETF fund (520700) has shown significant market activity, with a 4.00% increase and a turnover rate exceeding 55.40%, indicating strong investor interest in innovative pharmaceutical stocks [1] Group 1: Company Developments - Innovent Biologics reported promising clinical data for its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 at the 2025 ASCO annual meeting, focusing on advanced non-small cell lung cancer [1] - IBI363 has shown controllable safety and encouraging efficacy trends in squamous non-small cell lung cancer and wild-type lung adenocarcinoma, contributing to long-term survival benefits [1] - At the ASCO conference, Innovent Biologics had a total of 8 oral presentations, accounting for approximately 2% of the total presentations at the event [1] Group 2: Market Analysis - Morgan Stanley has raised its sales forecasts for Innovent's IBI363 and IBI343, citing their significant potential and the likelihood of global development or licensing opportunities [2] - GF Securities emphasizes the value of investing in Hong Kong innovative drugs, noting a shift in market focus from traditional sectors to long-term strategic areas like the Sino-U.S. technology competition [2] - The recent emergence of the DeepSeek large model has positively influenced investor sentiment, leading to a systematic reassessment of China's potential in key technology sectors [2]

Core Viewpoint - The recent surge in the Hong Kong stock market, particularly in the innovative drug sector, is attributed to significant inflows of capital and positive developments in clinical research, indicating a robust growth trajectory for the industry [1][3][4]. Group 1: Market Performance - The Hong Kong stock market showed slight gains, with the Hong Kong Stock Connect innovative drug ETF (159570) rising by 3.88% and achieving a trading volume exceeding 5 billion yuan [1]. - The ETF experienced a net inflow of over 21 million yuan during the trading session, following a substantial inflow of over 91 million yuan the previous day [1]. Group 2: Company Developments - The constituent stocks of the Hong Kong Stock Connect innovative drug ETF saw collective gains, with notable increases such as over 15% for Innovent Biologics and over 3% for both CSPC Pharmaceutical Group and CanSino Biologics [3]. - Innovent Biologics presented promising clinical data at the 2025 ASCO annual meeting, showcasing its first-in-class PD-1/IL-2α-bias bispecific antibody IBI363 for treating advanced non-small cell lung cancer [3]. - Morgan Stanley has raised its sales forecasts for Innovent's products, indicating strong potential for IBI363 and IBI343 in both domestic and international markets [3]. Group 3: Industry Trends - The current wave of innovation in the pharmaceutical sector is seen as a natural progression of China's pharmaceutical industry, with a significant increase in the number of innovative drugs entering the market [4]. - The period from 2025 to 2028 is projected to be critical for Chinese innovative drug companies as they are expected to collectively enter a profitability phase, marking a significant shift in the industry [4]. - The ASCO conference highlighted a record number of 73 oral presentations for Chinese innovative drug assets, reflecting the growing international recognition and demand for these products [5]. Group 4: Investment Opportunities - The Hong Kong Stock Connect innovative drug ETF (159570) is noted for its high concentration in innovative drug companies, with over 72% of its top ten holdings in leading firms [9]. - The ETF is characterized by a high weight of innovative drugs (up to 85%) and a relatively low valuation compared to the market, making it an attractive investment option [9]. - The Chinese innovative drug sector is experiencing a surge in business development (BD) activities, with increasing recognition and transaction values for innovative drug assets [6][7].