Summary of Xiansheng Pharmaceutical Conference Call Company Overview - **Company**: Xiansheng Pharmaceutical - **Industry**: Pharmaceutical, focusing on oncology and neurology Key Points Oncology Pipeline Highlights - **Core Products**: - Enze Shou (苏维西西达单抗) has been approved and included in the medical insurance directory, showing clear overall survival (OS) benefits for platinum-resistant ovarian cancer [6] - Kexaila (曲拉西利) is a CDK46 inhibitor, conditionally approved in 2022, expected to enter the medical insurance directory by the end of 2024 [6] - Enlituz (EGFR monoclonal antibody) is also expected to enter the medical insurance directory by the end of 2024 [6] New Product Launches - **Dali Le Sheng**: A new insomnia drug with significant market potential, expected to enhance performance rapidly. It reaches plasma peak in 1-2 hours and has an 8-hour half-life, aligning with human sleep cycles [2][3][7] - **Future Innovations**: Multiple innovative drugs are expected to launch in the coming years, including: - Madunosawe (抗流感), anticipated approval in 2026 [11] - New RSV infection drug, currently in slower clinical progress [11] Research and Development Investments - **R&D Spending**: In the first half of 2025, R&D investment reached 1.03 billion yuan, accounting for approximately 29% of revenue [4] - **Funding**: Raised 1.5 billion HKD through share placement, with 90% allocated for R&D [4] - **BD Collaborations**: Significant partnerships with companies like AbbVie, indicating international recognition of innovation capabilities [5] Market Potential and Competitive Landscape - **Insomnia Market**: The insomnia prevalence in China is 29.2%, with Dali Le Sheng addressing unmet needs in sleep onset and maintenance without next-day drowsiness [7][10] - **Safety Profile**: Dali Le Sheng is classified as a non-controlled substance, indicating a high safety profile and no addiction potential, allowing for broader market access [10] Financial Projections - **Short-term Growth**: Existing products entering the medical insurance directory and new launches like Dali Le Sheng are expected to drive revenue and profit growth [8][14] - **Long-term Outlook**: Continuous R&D investment and a robust pipeline suggest sustained growth momentum, with a target price of 20.16 HKD and a total market value of 48 billion RMB, indicating over 60% upside potential from current prices [4][8] Risks and Challenges - **Market Risks**: Potential risks in the autoimmune sector, particularly with the consistency evaluation of existing products, but new products like Jack One inhibitors are expected to mitigate these risks [15][16] Summary of Current Pipeline Performance - **Core Products**: The existing pipeline is performing well, with significant market share for key products like Xianbixin injection [15] - **Growth Opportunities**: New indications for existing drugs, such as Shisuan Jianjia for post-stroke cognitive impairment, are being explored for additional growth [16]

智通财经APP获悉，国金证券发布研报称，先声药业(02096)短期管线放量与长期创新迭代形成共振，成 长确定性强，预测2025/2026/2027年实现营业收入76.3亿/91.0亿/110.4亿元，同比 +15.0%/+19.3%/+21.4%，归母净利润11.5亿/13.8亿/16.6亿元，同比+57.3%/+19.4%/+20.5%，对应EPS为 0.44/0.53/0.64元(已考虑2025年9月配股1.12亿股)。根据DCF估值，对应合理目标价为20.16港币，首次覆 盖，给予"买入"评级。 长期来看，自研管线聚焦差异化，多款产品已实现BD，创新能力持续验证，技术平台和管线有望持续 BD出海 创新转型成效显著，创新药收入占比持续提升至77% 公司聚焦神经、肿瘤、自免及抗感染四大核心治疗领域，深耕市场三十年。凭借自研+BD双轮驱动，商 业化创新药已增至10款，创新药收入占比从2020年的45%提升至2025H1的77%，收入结构持续优化，创 新转型成果显著。 短期来看，核心管线进入密集收获期，医保准入加速业绩兑现;重磅失眠药兼具消费属性，市场潜力巨 大 短期来看，核心管线密集收获，医保加速放量：①肿瘤 ...

机构：华泰证券 们预计2026 年读出PoC 数据，公司ADC 平台的技术能力持续验证。 公司管线全球化有望持续推进 公司加速推动管线的全球化布局，多个产品/技术平台有望推动海外探索：1）SIM0709 是全球顺位第二 的TL1A/IL-23p19 双抗，且作为长效分子，符合自免药物的研发方向，全球竞争力显著；2）SIM0237 （PD-L1/IL-15 融合蛋白）已披露I/II 期临床结果，其中3 名膀胱癌CIS 患者均达到CR；3）新一代NMTi 载荷的ADC 管线带来产业领域升级，EGFR/cMet ADC 等均有全球FIC 潜力。此外，公司已出海管线的 全球临床正快速推进：1）SIM0500的中美I 期阶段入组中，和艾伯维的合作进展顺畅；2）SIM0278 已 在国内启动AD II 期，合作伙伴Almirall 已启动斑秃II 期。 新品种进入兑现期，成为业绩驱动 新品种已成为后续增长的强大动力：1）CNS 领域，达利雷生作为无成瘾性且可改善日间功能的DORA 类抗失眠药物，较传统药物安全性更佳，且其未纳入精神二类管控，处方和销售渠道限制较少，9 月开 售以来正迅速爬坡；2）肿瘤领域，口服SERD 联 ...

证券研究报告 先声药业 (2096 HK) SIM0613 出海；创新平台全球潜力兑 现启动 | 华泰研究 | | | 事件点评 | 投资评级(维持): | 买入 | | --- | --- | --- | --- | --- | --- | | 2025 年 | 12 月 | 23 日│中国香港 | 生物医药 | 目标价(港币): | 19.82 | 12 月 22 日，公司公告其 SIM0613（LRRC15 ADC）的海外权益以 4,500 万美元首付款、10.6 亿美元总金额及分级特许权使用费授权予法国益普生。 本交易是公司 2025 年第 3 个对外授权项目，验证公司创新药管线步入兑现 阶段，后续随着新管线的陆续临床/临床前验证，我们认为公司产品对外授 权有望形成趋势。维持"买入"评级。 SIM0613 全球进度靠前，公司 ADC 平台技术验证 LRRC15 在多种实体瘤和肿瘤相关成纤维细胞（CAF）表面高表达，LRRC15 ADC 能够直接杀伤靶点高表达肿瘤细胞，还有机会通过 CAF 将 ADC 分子 带入异质性的肿瘤组织内部，改善肿瘤微环境。SIM0613 的优势在于：1） 已在骨肉瘤和 TNB ...

Investment Rating - The report maintains a positive outlook on the insomnia treatment market, highlighting the potential for new drug sales performance in this sector [20][32]. Core Insights - The insomnia treatment market in China is characterized by a significant unmet need, with over 200 million individuals estimated to suffer from insomnia symptoms, representing a large consumer market potential [16][24]. - The report emphasizes the shift towards innovative insomnia medications, particularly focusing on new types of benzodiazepine receptor agonists (BZRAs) and dual orexin receptor antagonists (DORAs) as key areas for development [25][38]. - The introduction of new drugs like JY-202 (地达西尼) and DORA medications is expected to reshape the market dynamics, with a forecasted rapid increase in market share and sales [34][39]. Market Overview - The insomnia drug market in China has seen stagnant growth due to a lack of new effective treatments, with the market size in 2023 estimated at 31.62 billion yuan [24]. - The report outlines the historical sales performance of major insomnia medications, indicating a long gap since the last new product launch in 2007, which has contributed to the current market stagnation [24][25]. - The report projects a significant increase in the market size and sales for innovative insomnia drugs, particularly with the anticipated approval and market entry of new products [34][39]. Drug Development Trends - The report identifies two main directions for insomnia drug innovation: improvements on existing BZRAs and the development of DORAs, which are expected to have lower addiction risks and better patient compliance [25][38]. - The new drug JY-202 is highlighted for its selective action on the GABAA receptor, which may reduce side effects associated with traditional insomnia medications [34]. - The report also notes the successful clinical trial results for DORAs, which have shown significant improvements in sleep quality without the risk of addiction, making them suitable for broader consumer use [38][39]. Key Players and Recommendations - The report suggests focusing on companies like 京新药业 (JY-202) and 先声药业 (DORA medications) as they are positioned to capitalize on the emerging market opportunities in insomnia treatment [34][39]. - It recommends monitoring the sales performance of these new drugs as they enter the market, particularly in the context of changing consumer behavior and increasing awareness of sleep health [20][32].

证券研究报告 | 医药生物 | 2025年12月20日 www.hczq.com 华创医药投资观点&研究专题周周谈 ·第155期 失眠治疗蓝海大市场,看好上市新药销售表现 本周专题联系人:朱珂琛 | 华创医药团队： | | | --- | --- | | 首席分析师郑辰 | 执业编号: S0360520110002邮箱: zhengchen@hcyjs.com | | 联席首席分析师刘浩 | 执业编号:S0360520120002邮箱:liuhao@hcyjs.com | | 医疗器械组组长李婵娟 | 执业编号: S0360520110004邮箱: lichanjuan@hcyjs.com | | 中药和流通组组长高初营 | 执业编号: S0360524070002邮箱: gaochulei@hcyjs.com | | 分析师王宏雨 | 执业编号: S0360523080006邮箱:wanghongyu@hcyjs.com | | 分析师朱珂琛 | 执业编号: S0360524070007邮箱: zhukechen@hcyjs.com | | 分析师陈俊威 | 执业编号：S0360525060002邮箱:ch ...

智通财经APP获悉，国金证券发布研报称，先声药业(02096)短期管线放量与长期创新迭代形成共振，成 长确定性强,预测2025/2026/2027年实现营业收入76.3亿/91.0亿/110.4亿元,同比+15.0%/+19.3%/+21.4%,归 母净利润11.5亿/13.8亿/16.6亿元，同比+57.3%/+19.4%/+20.5%，对应EPS为0.44/0.53/0.64元(已考虑2025 年9月配股1.12亿股)。根据DCF估值，对应合理目标价为20.16港币，首次覆盖，给予"买入"评级。 NMTiADC新技术平台有望克服ADC耐药，后续相关产品进入临床有望加速验证平台实力。早研管线聚 焦差异化靶点，SIM0278(TL1A/IL-23p19双抗)、SIM0613(LRRC15-ADC)等多管线均为潜力靶点。近几 年公司多款早研管线出海，且合作对象不乏大MNC，创新能力持续获得海外企业的认可。目前公司加 强早研投入，未来数十款早研管线中仍有持续BD可能。 存量核心品种持续贡献稳定现金流 先必新注射液作为卒中治疗领域标杆产品，2025H1市占率达29%;恩维达、恩度深度布局肿瘤领域有望 实现稳健增长; ...

热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 国金证券主要观点如下： 创新转型成效显著，创新药收入占比持续提升至77% 公司聚焦神经、肿瘤、自免及抗感染四大核心治疗领域，深耕市场三十年。凭借自研+BD双轮驱动，商 业化创新药已增至10款，创新药收入占比从2020年的45%提升至2025H1的77%，收入结构持续优化，已 完成从仿制药龙头向创新药企的战略转型，创新转型成果显著。 短期来看，核心管线进入密集收获期，医保准入加速业绩兑现；重磅失眠药兼具消费属性，市场潜力巨 大 短期来看，核心管线密集收获，医保加速放量：①肿瘤领域科赛拉、恩立妥2024年底纳入医保，恩泽舒 2025年底纳入医保目录，三款产品凭借差异化机制与指南推荐，有望快速抢占市场。②神经领域：重磅 失眠药达利雷生作为非二类管控品种，起效快、无成瘾性，竞品稀缺，兼具消费属性，峰值有望超40亿 元；先必新舌下片与注射液形成序贯疗法，拓展卒中后认知障碍适应症有望带来新增量。此外，玛氘诺 沙韦、乐德奇拜单抗等六款产品即将获批，协同现有渠道加速放量。核心产品密集进入收获期，短期营 收和扣非净利润有望保持稳中有进。 长期来看，早研管线聚焦差异化，多 ...

Core Viewpoint - The article highlights the significant rise in the promotion of prescription weight loss drugs during this year's Double 11 shopping festival, drawing comparisons to the popularity of the iPhone 17, and raises concerns about the compliance of such promotions with existing regulations [1][6]. Group 1: Promotion of Prescription Drugs - Major e-commerce platforms like JD.com, Alibaba, and Meituan have launched promotional activities that include prescription drugs, offering discounts of 10%-20% on various medications [3][4]. - The sales of weight loss drugs, particularly those like Tirzepatide, have surged, with sales growth exceeding 5.7 times compared to previous periods [6]. - The promotional strategies include common tactics such as "spend 300 yuan to get 50 yuan off" and "limited-time flash sales," which are typically seen in consumer goods [1][8]. Group 2: Regulatory Concerns - The promotion of prescription drugs may violate existing regulations, as certain promotional activities for prescription medications are explicitly prohibited [4][9]. - Legal experts indicate that while some promotional methods may not directly constitute illegal practices, they could still be interpreted as misleading advertising under current laws [10][14]. - The article discusses the potential for e-commerce platforms to face scrutiny for their promotional practices, especially if they lead to consumer misuse of prescription medications [12][18]. Group 3: Market Dynamics and Consumer Behavior - The article notes that the ease of obtaining prescriptions online has raised concerns about the potential for drug misuse, as consumers can quickly receive prescriptions without thorough medical evaluations [20][22]. - The introduction of "money-back guarantees" for weight loss drugs during promotions may encourage consumers to purchase these medications without proper medical guidance [16][21]. - The article emphasizes the importance of responsible marketing and the need for regulatory oversight to prevent potential health risks associated with the misuse of prescription drugs [23].

Core Insights - The article discusses the introduction of Daridorexant, a new generation insomnia medication, at the 2025 China International Import Expo, highlighting its potential to reshape the insomnia treatment landscape in China, where nearly half of adults experience sleep issues [3][20]. Industry Overview - The insomnia treatment market in China is significant, with the sleep economy exceeding 300 billion yuan and showing steady growth, indicating further expansion potential as awareness of sleep quality increases [16]. - Traditional insomnia medications have limitations, including dependency and residual effects, leading to a demand for more precise and natural treatment options [5][6]. Product Introduction - Daridorexant, developed by Swiss company Idorsia, is a dual orexin receptor antagonist (DORA) that targets the underlying physiological mechanisms of insomnia, distinguishing it from traditional sedatives [8][11]. - The drug has a half-life of approximately 8 hours, allowing for a full night's sleep without next-day drowsiness, aligning with modern lifestyle demands [11][17]. Clinical Data - Clinical studies published in The Lancet Neurology demonstrate that Daridorexant significantly improves sleep onset and maintenance compared to placebo, extending total sleep time without altering sleep structure or causing dependency [13][14]. - In China, the drug's phase III clinical trial showed consistent efficacy and safety results, reducing sleep onset time by 35 minutes and nighttime awakenings by 30 minutes, while also improving daytime functioning [14]. Competitive Advantages - Daridorexant's mechanism directly addresses insomnia's pathophysiology, presenting a safety profile with low dependency risk, making it more appealing for prescriptions [17]. - The drug is not classified as a controlled substance, simplifying prescription processes and enhancing accessibility for patients [17]. Local Production and Accessibility - Local production of Daridorexant is expected to reduce costs and improve patient accessibility, with plans for production in Hainan, China, anticipated to meet the needs of insomnia patients effectively [18][19]. - The local manufacturing strategy aims to ensure stable supply chains and lower drug prices, which are critical for chronic disease management [19]. Treatment Paradigm Shift - The introduction of Daridorexant signifies a shift in insomnia treatment from forced sleep to promoting natural sleep, focusing on overall sleep health management rather than merely symptom control [20].