奥布替尼加速放量，创新管线推进顺利 诺诚健华(9969) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——诺诚健华 2024H1 点评 | --- | --- | --- | --- | |----------|-------------------|----------------------------|--------------------------| | | 丁丹(分析师) | 甘坛焕(分析师) | 付子阳(研究助理) | | | 0755-23976735 | 021-38675855 | 0755-23976666 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | fuziyang028496@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S0880123100022 | 本报告导读： 奥布替尼凭借 MZL 独家适应症加速放量，全年收入增长指引上调至 35% 。自免和 实体瘤管线拓展顺利，创新管线有望未来 1-2 年陆续获批上市，维 ...

[ T able_StockInfo] 2024 年 08 月 21 日 证券研究报告•2024 年半年报点评 当前价：4.48 港元 诺诚健华（9969.HK）医疗保健 目标价：——港元 业绩超预期，建立血液瘤领域的领导地位 [Table_Summary 事件：8月 20 ]日，诺诚健华公布 2024年中期业绩，2024年上半年营业收入为 4.2亿元（+11.2%），其中奥布替尼实现强劲增长，销售额为 4.2亿元（+30%）， 业绩超预期。 奥布替尼销售强劲增长，血液瘤和自身免疫病推进顺利。奥布替尼上半年销售 额为 4.2亿元（+30%），其中 Q2同比增长 48.8%。奥布替尼是中国首个且唯一 获批针对 MZL的 BTK 抑制剂。奥布替尼在美国针对复发或难治性 MCL的注册 性Ⅱ期临床试验已完成患者招募，美国 NDA 的提交计划正在讨论中。自免适应 症上，ITP 处于临床Ⅲ期，预计 2024 年末或 2025 年初完成患者招募。系统性 红斑狼疮（SLE）Ⅱb 期临床试验正在进行中，截至 2024 年 8 月 20 日患者招 募已接近完成。 TYK2抑制剂国内研发第一梯队，两款产品研发进展顺利。公司拥有两款 ...

Financial Performance - In the first half of 2024, the company achieved a net profit of 268 million yuan, a significant improvement compared to a net loss of 429 million yuan in the same period last year, indicating a narrowing of losses [4]. - The company reported a revenue of RMB 1.5 billion for the first half of 2024, representing a year-over-year increase of 25% [13]. - The company's revenue for the first half of 2024 reached RMB 419,737,910.92, an increase of 11.17% compared to RMB 377,549,019.52 in the same period last year [24]. - The net loss attributable to shareholders was RMB -261,840,060.10, an improvement from RMB -422,209,548.49 in the previous year [24]. - The basic and diluted earnings per share were both -0.16, compared to -0.25 in the same period last year [25]. - The company expects a revenue guidance of RMB 3 billion for the second half of 2024, indicating a projected growth of 20% compared to the first half [16]. - The gross margin for the first half of 2024 improved to 60%, up from 55% in the previous year [13]. Research and Development - Research and development expenses amounted to 421 million yuan, an increase of 60 million yuan compared to the same period last year, reflecting the company's ongoing investment in new technology platforms and clinical trials [4]. - Research and development expenses accounted for 100.40% of revenue, an increase of 4.73 percentage points from 95.67% year-on-year [25]. - The company has 13 products in the research pipeline, with 2 products entering the commercialization stage [30]. - The company is conducting over 30 global trials at various clinical stages, indicating a strong commitment to R&D [30]. - The company reported a total R&D investment of ¥421,404,233.69, representing a 16.67% increase compared to ¥361,193,556.11 in the same period last year [144]. - The company has established a biomarker-based translational medicine research platform to enhance drug development efficiency and clinical trial data evaluation [156]. Product Development and Pipeline - The company continues to focus on developing innovative drugs for oncology and autoimmune diseases, addressing significant unmet clinical needs in the global market [4]. - Ongoing research and development efforts have led to the advancement of two new drug candidates, expected to enter clinical trials in Q3 2024 [16]. - The company has completed a strategic acquisition of a smaller biotech firm for RMB 200 million, enhancing its product pipeline [15]. - The core product, Acalabrutinib (Ibrutinib), achieved strong sales of 417 million CNY in the first half of 2024, representing a year-on-year growth of 30.02%, with Q2 2024 showing a remarkable increase of 48.81% [32]. - The company has 485 R&D personnel, accounting for 43.73% of the total workforce, with an average salary of ¥24.39 million [148]. - The company is developing multiple products for autoimmune diseases caused by B or T cell dysfunction, including ICP-332 and ICP-488 [155]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by 2025 [14]. - New product launches are anticipated to contribute an additional RMB 500 million in revenue by the end of 2024 [15]. - The company aims to establish a leadership position in hematological malignancies, leveraging ibrutinib and a robust pipeline of investigational drugs [52]. - The company is exploring diverse R&D models, including internal development and partnerships, to improve resource utilization in drug development [136]. Regulatory and Compliance - The company must comply with ongoing regulatory scrutiny for its approved drugs, which could impose additional costs and limit commercial potential [175]. - The company has submitted a BLA to the NMPA for urgently needed imported drugs and is included in priority review, while other products are still in the development stage [177]. - The company is subject to ongoing inspections by regulatory authorities to ensure compliance with GMP requirements, and failure to comply could lead to significant delays in product supply [183]. Challenges and Risks - The company faces risks related to adverse events from its products, which could lead to clinical trial suspensions or stricter regulatory requirements [168]. - The company is exposed to risks from rapid technological changes in drug development, which could undermine its competitive advantage [166]. - The company has limited operating history since its establishment in November 2015, making it challenging to predict future performance reliably [190]. - The company faces uncertainty in revenue growth due to reliance on market expansion of products like Obinutuzumab and ongoing R&D projects [191]. - The company may encounter risks from price adjustments in drug policies, which could negatively affect future drug revenues [187].

| A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-024 | | --- | --- | --- | --- | | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 2024 年半年度募集资金存放与实际使用情况 的专项报告 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。 一、 募集资金基本情况 （一）实际募集资金金额、资金到位时间 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）首次公开发行股票 并在科创板上市的注册申请于 2022 年 7 月 15 日经中国证券监督管理委员会同 意注册（证监许可[2022]1524 号《关于同意诺诚健华医药有限公司首次公开发行 股票注册的批复》），公司据此采用向战略投资者定向配售、网下向符合条件的 投资者询价配售和网上向持有上海市场非限售 A 股股份和非限售存托凭证市值 的社会公众投资者定价发行相结合的方式公开发行了 264,648,217 股股票，每股 发行价格为人民币 11.03 元，募集资金总额为人民币 291 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 419.7 million, an increase of 11.2% compared to RMB 377.5 million for the same period in 2023[2]. - Gross profit for the same period was RMB 359.6 million, with a gross margin of 85.7%, up from 79.9% in the previous year[2][3]. - The net loss for the six months ended June 30, 2024, was RMB 268.0 million, a reduction of 37.6% from RMB 429.2 million in the prior year[3][5]. - Adjusted net loss for the period was RMB 242.99 million, compared to RMB 206.26 million in the same period of 2023[5]. - The company reported a basic and diluted loss per share of RMB 0.16 for the six months ended June 30, 2024, compared to RMB 0.25 for the same period in 2023[153]. - The company incurred a loss before tax of RMB 267,923 thousand for the six months ended June 30, 2024, an improvement from a loss of RMB 429,184 thousand in the same period of 2023[153]. - The company reported a loss attributable to equity holders of RMB (261,840) thousand for the six months ended June 30, 2024, an improvement from a loss of RMB (422,211) thousand in 2023[184]. Research and Development - Total operating expenses increased by 5.2% to RMB 669.5 million, driven by a rise in R&D expenses to RMB 420.8 million, reflecting increased investment in technology platform innovation and clinical trials[3]. - R&D expenses for the six months ended June 30, 2024, were RMB 420,822 thousand, compared to RMB 358,130 thousand in the prior year, showing an increase in investment in innovation[153]. - The company is developing drugs targeting B cell signaling and T cell pathway abnormalities for autoimmune diseases[10]. - The company is actively pursuing the development of new candidates targeting T-cell mediated autoimmune diseases, with promising early results for ICP-332 and ICP-488[21]. - The company is developing multiple drugs targeting key hematological malignancy targets, including BCL-2, CD20×CD3, and E3 ligase[28]. Product Development and Clinical Trials - The company plans to accelerate clinical development and invest in competitive product lines, supported by a strong cash position[3]. - The company has completed patient recruitment for a Phase II registration trial for relapsed/refractory mantle cell lymphoma (MCL) in the U.S., with NDA submission plans under discussion[8]. - The company is conducting a Phase III registration trial in China for MCD subtype diffuse large B-cell lymphoma (DLBCL), comparing Acalabrutinib combined with R-CHOP against R-CHOP alone[8]. - The company has initiated a Phase II registration trial for ICP-723 in adult and adolescent patients with NTRK gene fusion-positive advanced solid tumors in mainland China, achieving an observed overall response rate (ORR) of 80-90%[16]. - The company is conducting a Phase III study evaluating the efficacy and safety of obinutuzumab combined with R-CHOP for treating newly diagnosed DLBCL patients with the MCD subtype, currently recruiting patients at 44 clinical trial centers in China[36]. Market and Sales Performance - Revenue from the drug Orelabrutinib increased by 48.8% in Q2 2024, contributing significantly to overall revenue growth[2]. - In the first half of 2024, the company's core product, Acalabrutinib (Obinutuzumab), generated revenue of RMB 417.0 million, a 30.0% increase from RMB 320.7 million in the same period of 2023[6]. - The company aims to leverage single and combination therapies to treat various hematological malignancies, positioning itself as a leader in the global hematological oncology field[6]. - The company is focused on expanding its market coverage and optimizing sales operations to enhance market penetration and increase revenue from Acalabrutinib[6]. - The company anticipates continued strong sales growth in the second half of 2024, supported by its enhanced commercialization capabilities and expanding product portfolio[18]. Financial Position and Assets - Cash and cash equivalents as of June 30, 2024, were approximately RMB 7.99 billion, providing flexibility for clinical development and investment in competitive product lines[3]. - Net current assets amounted to RMB 5,959.0 million as of June 30, 2024, primarily due to cash and bank balances of RMB 6,903.7 million and trade receivables of RMB 280.7 million[112]. - The company's total equity as of June 30, 2024, was RMB 6,938,479 thousand, down from RMB 7,180,705 thousand, reflecting a decrease of approximately 3.4%[158]. - The total amount raised from the issuance of RMB shares was approximately RMB 2,778.82 million, with a significant portion allocated for new drug research and development[151]. - The company has a bank credit line of RMB 400.0 million, of which RMB 43.9 million has been drawn as of June 30, 2024[130]. Corporate Governance and Compliance - The company has established an audit committee consisting of one non-executive director and two independent non-executive directors to oversee financial reporting and internal controls[145]. - The company will continue to review and monitor corporate governance practices to ensure compliance with the corporate governance code[140]. - The company has not made any significant investments or acquisitions as of June 30, 2024, and holds no major investments[128]. - There were no significant litigations or arbitrations involving the company during the reporting period[146]. Future Outlook - The company plans to submit a Biologics License Application (BLA) for the combination of Tanxiaotai monoclonal antibody and Lenalidomide for adult patients with relapsed refractory DLBCL by mid-2025[20]. - The company plans to initiate Phase III trials for ICP-332 in atopic dermatitis in Q4 2024 and has received IND approval from the FDA for further studies[12]. - The company is exploring the use of Aobutinin for various autoimmune diseases, with ongoing trials for systemic lupus erythematosus (SLE) and other indications[21]. - The company plans to explore the combination of ICP-B05 with other immunotherapies across various cancer indications after collecting safety data[53]. - The company is actively seeking licensing and clinical collaboration opportunities to enhance its pipeline and operational efficiency[23].

诺诚健华医药有限公司 关于召开 2024 年半年度业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： 会议召开时间：2024 年 8 月 21 日(星期三)上午 11:00-12:00 会议召开地点：上海证券交易所上证路演中心（网址： http://roadshow.sseinfo.com/） | A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-023 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | （三） 会议召开方式：上证路演中心网络互动 三、参加人员 董事会主席兼行政总裁：Jisong Cui（崔霁松）博士 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 8 月 14 日(星期三)至 8 月 20 日(星期二)16:00 前登录 上 证 路 演 中 心 网 站 首 页 点 击 " 提 问 预 征 集 " 栏 目 或 通 过 公 司 邮 箱 IR@innocarepharma.c ...

Investment Rating - The report assigns a "Buy" rating for the company with a target price of HKD 7.30, based on a current price of HKD 4.82 [1]. Core Insights - The company is experiencing a gradual improvement in commercialization, with projected revenue growth from HKD 738.54 million in 2023 to HKD 872.42 million in 2024, driven by the renewal of medical insurance for Obinutuzumab and the expansion of the MZL indication [2][3]. - The company has a strong pipeline with multiple drugs in critical clinical stages, including Obinutuzumab for various cancer indications and autoimmune diseases, and TYK2 inhibitors leading in domestic research and development [2][3]. - The company reported a significant increase in revenue from HKD 6.3 billion in 2022 to HKD 7.4 billion in 2023, with a notable rise in Obinutuzumab sales [14]. Summary by Sections 1. Commercialization and Clinical Development - The company has one drug approved for market, Obinutuzumab, and has submitted a market application for Tafasitamab, indicating strong R&D capabilities [12]. - Revenue from Obinutuzumab reached HKD 6.7 billion in 2023, reflecting an 18.5% year-on-year growth [16]. 2. Obinutuzumab's Market Position - Obinutuzumab is the third BTK inhibitor approved in China, with a growing market presence amidst competition from other BTK inhibitors [16][17]. - The drug has been included in medical insurance since the end of 2021, which is expected to enhance its market penetration [17]. 3. TYK2 Inhibitors - The company is at the forefront of TYK2 inhibitor development in China, with two candidates in clinical trials, ICP-332 and ICP-448, showing promising results [2][3]. - The global market for TYK2 inhibitors is expanding, with peak sales estimates for the first approved TYK2 inhibitor reaching USD 4 billion [2]. 4. Financial Projections - Revenue forecasts for the company are optimistic, with expected revenues of HKD 8.7 billion in 2024, HKD 12.8 billion in 2025, and HKD 18.3 billion in 2026 [3][4]. - The company maintains a strong cash position, with cash reserves reaching HKD 82 billion as of Q1 2024 [14].

Investment Rating - The report maintains a "Buy" rating for the company [5]. Core Views - The BLA application for Tafasitamab has been accepted by NMPA and is prioritized for review, showing excellent efficacy and good safety, indicating strong potential for market growth [3][4]. - Tafasitamab is expected to achieve peak sales exceeding 1 billion RMB, with a promising outlook for the company's oncology and autoimmune pipeline [4]. - The sales of Acalabrutinib are anticipated to accelerate in 2024, with three indications entering medical insurance and being included in clinical guidelines, which is expected to extend treatment duration [4]. Summary by Sections Company Overview - The report discusses the acceptance of the BLA application for Tafasitamab in treating r/r DLBCL, highlighting its efficacy with a median overall survival (mOS) of 33.5 months compared to the current mOS of 5-12 months for existing treatments [4]. Financial Projections - The company is projected to achieve revenues of 1.25 billion RMB in 2024, with a growth rate of 28% [7]. - Acalabrutinib is expected to generate sales of 671 million RMB in 2023, with revenue growth exceeding 30% in 2024 [4]. Pipeline Development - The report outlines several key developments in the company's pipeline, including: - The initiation of Phase III trials for ICP332 in 2024Q3 and the start of a Phase II trial for vitiligo in China [4]. - The completion of patient enrollment for ICP488 in psoriasis, with data readout expected by the end of 2024 [4]. - The advancement of ICP-723 for late-stage solid tumors, with NDA submission anticipated by the end of 2024 [4]. Market Context - The report notes that DLBCL accounts for 31%-34% of NHL globally and 46% in China, indicating a significant market opportunity for Tafasitamab [4].

Investment Rating - The report maintains a "Buy" rating for the company [3]. Core Views - The company reported Q1 2024 revenue of 166 million RMB, a year-on-year decrease of 12.4%, with a gross margin of 85.4%, up by 8.1 percentage points due to improved production efficiency and reduced costs. The net loss was 146 million RMB, an increase of 132 million RMB year-on-year, primarily due to foreign exchange losses and R&D expenses. The company has a strong cash reserve of approximately 8.2 billion RMB, sufficient for further commercialization progress. Revenue forecasts for 2024-2026 are maintained at 948 million, 1.248 billion, and 1.7 billion RMB respectively [2][6]. Summary by Sections Revenue and Growth - The sales of the drug Aobutini reached 164 million RMB in Q1 2024, representing a 9% year-on-year growth. The drug is the only one approved in China for treating r/r MZL and is included in the 2024 CSCO lymphoma guidelines as a first-line treatment recommendation. NDA submissions for multiple indications are expected in 2024, including CLL/SLL in China and r/r MCL in the US [2][6]. R&D Progress - R&D expenses for Q1 2024 were 178 million RMB, an increase of 26.1%. The company is making significant progress in its R&D pipeline, with several key developments expected in 2024, including BLA submission for Tafasitamab and various clinical trials for other treatments [2][6]. Financial Performance - The company’s financial summary shows a significant decrease in net profit from -887 million RMB in 2022 to -631 million RMB in 2023, with projections for further losses in the coming years. However, the gross profit is expected to increase steadily, reflecting the company's potential for recovery and growth [6].

Financial Performance - In the first quarter of 2024, the company achieved a total revenue of RMB 165.82 million, a decrease of 12.44% year-on-year[8] - Sales revenue from the core product, Oubatinib (Yinokai®), reached RMB 164.80 million, representing a year-on-year growth of 8.87%[8] - The gross profit margin for the first quarter of 2024 was 85.4%, an increase of 8.1 percentage points compared to 77.3% in the same period last year[7] - The company reported a net loss attributable to shareholders of RMB 142.40 million for the first quarter[8] - Total revenue for Q1 2024 was ¥165,824,020.34, a decrease of 12.43% compared to ¥189,387,628.40 in Q1 2023[20] - Net loss for Q1 2024 was ¥145,660,375.68, compared to a net loss of ¥14,229,365.40 in Q1 2023, indicating a substantial decline in profitability[20][21] - The company's basic earnings per share for Q1 2024 was -¥0.08, compared to -¥0.01 in Q1 2023, highlighting a deterioration in earnings performance[21] Research and Development - Research and development expenses totaled RMB 177.73 million, accounting for 107.18% of total revenue, an increase of 32.75 percentage points year-on-year[8] - Research and development expenses rose to ¥177,728,720.87, an increase of 26.06% from ¥140,950,687.03 in Q1 2023, reflecting a focus on innovation[20] Cash Flow and Liquidity - The company experienced a net cash outflow from operating activities of RMB 84.04 million in the first quarter[8] - Cash flow from operating activities showed a net outflow of ¥84,043,543.78, improving from a larger outflow of ¥154,802,409.78 in Q1 2023[23] - Cash and cash equivalents at the end of Q1 2024 totaled ¥4,616,481,748.24, up from ¥3,993,788,388.71 at the end of Q1 2023, indicating improved liquidity[23] - The company reported a significant increase in cash inflow from investment activities, totaling ¥502,674,850.75, compared to a net outflow of ¥1,915,385.25 in Q1 2023[23] - As of March 31, 2024, the company held cash and cash equivalents of approximately RMB 8.2 billion[7] - The company's cash and cash equivalents as of March 31, 2024, amount to ¥8,201,839,334.55, a decrease from ¥8,287,136,644.81 as of December 31, 2023[18] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period is 17,655[12] - The total number of issued shares is 1,762,582,452, with 1,497,934,235 shares (approximately 84.99%) issued in Hong Kong and 264,648,217 shares (approximately 15.01%) issued on the Shanghai Stock Exchange[12] - The top shareholder, HKSCC NOMINEES LIMITED, holds 730,634,157 shares, representing 41.44% of the total shares[14] - The second-largest shareholder, HHLR Fund, L.P. and its concerted actors, holds 208,671,222 shares, accounting for 11.84%[14] - The company has not disclosed any significant changes in shareholder relationships or concerted actions among the top shareholders[15] Assets and Liabilities - The total assets decreased to ¥9,766,283,263.59 from ¥9,919,995,852.46 in the previous quarter, reflecting a reduction in overall company size[19] - The total liabilities decreased slightly to ¥2,712,214,039.61 from ¥2,739,290,198.68, indicating a minor improvement in the company's debt position[19] - Accounts receivable decreased to ¥232,958,854.23 from ¥276,377,549.08 over the same period[18] - Total current assets decreased to ¥8,620,713,615.47 from ¥8,765,324,062.77[18] - Non-current assets totaled ¥1,145,569,648.12, down from ¥1,154,671,789.69[18] - The company reported a decrease in long-term equity investments from ¥5,660,187.95 to ¥4,320,662.46[18] Accounting and Reporting - The company has adopted new accounting standards starting from 2024, impacting the financial statements from the beginning of the year[24] - The financial report is presented by Jisong Cui, the head of the company, along with key accounting personnel[24] - The report indicates that the company is not applicable for the new accounting standards or interpretations[24] - The announcement was made by the board of directors of the company on May 13, 2024[24] - The document contains a total of 14 pages, indicating a comprehensive report[24] - The company is focused on ensuring the accuracy of financial reporting under the new standards[24] - There are no specific performance metrics or user data provided in this document[24] - Future outlook and performance guidance are not detailed in this report[24] - No information on new products, technologies, market expansion, or mergers and acquisitions is included[24] - The report does not provide any financial figures or percentage changes[24] Product Information - Oubatinib is the first and only BTK inhibitor approved for the MZL indication in China, listed as a Class I recommendation in the CSCO lymphoma treatment guidelines[7]