| A | 股代码：688428 | 股简称：诺诚健华 A | 公告编号：2025-013 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 自愿披露关于奥布替尼新适应症 在中国上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 近日，诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）收到国家药 品监督管理局（NMPA）核准签发的《药品注册证书》，奥布替尼（商品名：宜 诺凯®）用于一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（以下简称 "CLL/SLL"）的新适应症上市申请获得批准。现将相关情况公告如下： 一、药品情况 药品名称：奥布替尼片 申请事项：药品注册（境内生产） 受理号：CXHS2400078 证书编号：2025S01123 上市许可持有人：北京诺诚健华医药科技有限公司 审批结论：批准增加适应症，新增适应症为：本品单药适用于成人慢性淋巴 细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。 二、药品 ...

Group 1 - The core viewpoint of the news is the performance and holdings of the Huatai-PineBridge Medical Services Flexible Allocation Mixed A Fund, which has shown significant returns in recent months and has a strong portfolio in the healthcare sector [1][3]. - As of April 24, 2025, the fund's latest net value is 1.5450 yuan, reflecting a growth of 1.25% [1]. - The fund has achieved a return of 18.21% over the past month, ranking 2 out of 8 in its category, and a return of 30.60% over the past three months, ranking 1 out of 8 [1]. - Year-to-date, the fund has returned 28.32%, also ranking 1 out of 8 in its category [1]. Group 2 - The top ten stock holdings of the fund account for a total of 64.17%, with significant positions in companies such as Heng Rui Pharmaceutical (10.23%), Kelun Pharmaceutical (9.09%), and Bai Li Tianheng (8.94%) [1]. - The fund was established on June 18, 2015, and as of March 31, 2025, it has a total asset size of 4.408 billion yuan [1]. - The fund manager, Zhang Wei, has a strong background in biomedical studies and has held various positions in the pharmaceutical research field prior to managing this fund [2].

Core Insights - The latest net value of Wanjiay Economic New Momentum Mixed C Fund (005312) is 1.6754 yuan, reflecting a decrease of 0.66% [1] - The fund has shown a return of 3.35% over the past month, ranking 200 out of 4491 in its category; a return of 32.05% over the past three months, ranking 29 out of 4444; and a year-to-date return of 33.98%, ranking 34 out of 4418 [1] Fund Holdings - The top ten stock holdings of Wanjiay Economic New Momentum Mixed C Fund account for a total of 75.95%, with the following allocations: - Ruixin Microelectronics (9.12%) - BeiGene-U (8.80%) - Deepin Technology (8.64%) - Innovent Biologics-U (7.88%) - Cambricon Technologies-U (7.65%) - iFlytek (7.51%) - Sierpo (7.46%) - Sanan Optoelectronics (6.89%) - BGI Genomics (6.18%) - Zhongwei Company (5.82%) [1] Fund Overview - Wanjiay Economic New Momentum Mixed C Fund was established on February 7, 2018, and as of March 31, 2025, it has a total scale of 1.223 billion yuan [1] - The fund manager is Huang Xingliang, who has extensive experience in the investment management industry [2]

Group 1 - The core viewpoint is that Innovent Biologics (09969) has seen a significant stock increase of over 15%, currently trading at HKD 10.16, with a transaction volume of HKD 421 million due to the acceptance of a new drug application for Zurletrectinib by the NMPA [1] - Zurletrectinib is a next-generation pan-TRK inhibitor developed by Innovent, effective against TRKA, TRKB, TRKC, and can overcome resistance mutations such as G595R and G667C, addressing limitations of first-generation TRK inhibitors [1] Group 2 - Pacific Securities highlights a rich pipeline of catalysts for the company in the next 12 months, particularly in the hematological malignancies field with approvals for drugs like Obinutuzumab and Tazemetostat [2] - In the autoimmune field, multiple clinical trials are progressing, including phase 3 trials for Obinutuzumab in ITP and phase 2 trials for ICP-332 in atopic dermatitis, indicating a robust development strategy [2]

医药板块持续走高 众生药业等多股涨停 智通财经4月22日电，午后医药板块持续走高，创新药方向继续领涨，众生药业、华森制药、富士莱涨 停，百利天恒、诺诚健华、新诺威、百济神州创历史新高，复旦张江、上海谊众、信立泰、热景生物等 涨幅靠前。消息面上，4月25日至4月30日，美国癌症研究协会（AACR）年会将在芝加哥召开。作为全 球规模最大的癌症研究会议之一，AACR年会一直是癌症领域最新研究成果的重要展示平台。 ...

Group 1 - The Hong Kong innovative drug sector showed strong performance in the afternoon, with notable increases in stock prices for companies such as Innovent Biologics and I-Mab, both rising over 10% [1] - BeiGene's stock also experienced a significant increase, nearing 10%, alongside substantial gains for CSPC Pharmaceutical Group, Rongchang Biopharmaceutical, and WuXi Biologics [1] - The article highlights that investors can buy Hong Kong stocks through A-share accounts without the need for the Hong Kong Stock Connect, allowing for T+0 trading [1]

Investment Rating - The industry investment rating is "Outperform the Market" [1][50]. Core Insights - Eli Lilly's first oral small molecule GLP-1 drug, Orforglipron, has successfully completed Phase 3 clinical trials, which is expected to change the landscape of weight loss medications [3][4]. - The ACHIEVE-1 trial showed that Orforglipron significantly reduced HbA1c levels by 1.3% to 1.6% from a baseline of 8.0% after 40 weeks, with over 65% of patients achieving HbA1c levels ≤6.5% [3][4]. - Patients receiving the highest dose of Orforglipron lost an average of 7.3 kg, indicating potential for further weight loss [4]. - Eli Lilly plans to submit a global application for Orforglipron for weight management by the end of this year and for type 2 diabetes treatment in 2026 [4][5]. Summary by Sections Industry Overview - The successful Phase 3 trial of Orforglipron positions it as a potential second oral GLP-1 drug in the U.S., following Novo Nordisk's Rybelsus [5]. Investment Strategy - Focus on "innovation," "overseas expansion," "equipment upgrades," and "consumer recovery" as key investment themes [7]. - Recommended companies include innovative drug developers and those with strong overseas market potential [7]. Key Companies to Watch - **Nocera Health**: Expected to achieve over 1 billion yuan in revenue from its core product, with a projected 49% year-on-year growth [8]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [11]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products [13]. - **Aier Eye Hospital**: Benefiting from increasing demand in ophthalmology and ongoing overseas expansion [22]. Market Performance - The pharmaceutical sector saw a decline of 0.36% last week, while the broader market index rose by 0.59% [25][36].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 23.29 RMB, compared to the last closing price of 17.86 RMB [1][6]. Core Insights - The company's revenue for 2024 reached 1.009 billion RMB, representing a year-on-year growth of 36.7%. The core product, Aobutini, achieved sales exceeding 1 billion RMB, with a year-on-year increase of 49.1% due to the expansion of MZL indications and improved commercialization capabilities [4]. - The gross margin increased to 86.3% in 2024, up 3.7 percentage points from 2023, primarily driven by changes in revenue structure and enhanced production efficiency of Aobutini [4]. - The company reported a loss of 453 million RMB for the period, a reduction of 193 million RMB or 29.9% year-on-year, attributed to increased drug sales, improved cost efficiency, and reduced unrealized exchange losses [4]. - As of December 31, 2024, the company had approximately 7.8 billion RMB in cash and cash equivalents [4]. Summary by Sections Financial Performance - Revenue for 2024 is projected at 1.009 billion RMB, with growth rates of 36.68% for 2024, 29.87% for 2025, 41.80% for 2026, and 32.16% for 2027 [9]. - The company expects to continue narrowing losses, with projected net losses of 441 million RMB in 2024 and 461 million RMB in 2025 [9]. Product Pipeline and Clinical Progress - In the hematological malignancies sector, Aobutini's NDA for first-line CLL/SLL has been accepted by NMPA, with approval expected in 2025. Additionally, Aobutini in combination with BCL2 inhibitor ICP-248 is entering Phase 3 clinical trials [5]. - In the autoimmune sector, Aobutini's Phase 3 clinical trial for ITP is accelerating, and the 2b phase for SLE has completed patient enrollment [5]. Future Catalysts - The company has a rich pipeline of catalysts expected within the next 12 months, including potential approvals for Aobutini and other products in various indications [6].

| 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度，并针对 具体的持续督导工作制定相应的工作计划 | 保荐机构已建立健全并有效执 行了持续督导制度，并制定了 | | | | 相应的工作计划 | | 2 | 根据中国证监会相关规定，在持续督导工作开始 议，明确双方在持续督导期间的权利义务，并报 | 保 荐 机 构 已 与 诺 诚健 华 签 订 《保荐协议》及《持续督导协 | | | 前，与上市公司或相关当事人签署持续督导协 | 议》，该协议明确了双方在持 | | | | 续督导期间的权利和义务，并 | | | 上海证券交易所备案 | 报上海证券交易所备案 | | 3 | 持续督导期间，按照有关规定对上市公司违法违 规事项公开发表声明的，应于披露前向上海证券 | 2024年度诺诚健华在持续督导 期间未发生按有关规定需保荐 机构公开发表声明的违法违规 | | | 媒体上公告 | 情况 | | 4 | 违规、违背承诺等事项的，应自发现或应当自发 | 年度诺诚健华在持续督导 2024 期间未发生违法违规或违背承 | | 5 | 通过日常沟 ...

相关ETF方面，恒生医疗ETF（513060）高开高走，盘中大涨超5%，成交额放量突破6亿元，换手率超 5%，交投活跃。成分股中多数上涨，药明合联大涨超15%；三生制药涨超10%；科伦博泰生物涨超 9%；药明生物、方舟健客、药明康德跟涨，涨幅均超8%。 湘财证券指出，近期中美互加关税对医药行业扰动较大，但中国医药行业出口额相对较小且主要集中于 原料药、医疗设备、低值耗材等领域。而与医疗服务领域实验室研发外包相关公司有较多涉及到美国市 场业务，因此医药外包产业短期受互加关税影响情绪面或有扰动。但从产业链来看，国内医药外包服务 公司已成为全球医药产业链重要一环，对美国大药企提升研发效率将更多精力聚焦于后端药品研发制 造，实现医药工业生产及价值创造提供了支撑。因此，我们认为关税对CXO行业的基本面的影响预计 将可控，建议把握板块下跌带来的配置机会。 近期在国家鼓励创新大背景下创新药产业链表现活跃，虽然医药工业复苏仍有待验证，行业受医保控费 压力仍在，但多层次的支付体系正在建立，医疗需求的刚性将共同推动行业企稳回升，建议关注高成长 及预期改善两大方向，具体而言：（1）高成长：医药外包服务中的ADCCDMO、减肥药产业 ...