A 股代码：688428 A 股简称：诺诚健华 港股代码：09969 港股简称：诺诚健华 2024 年 11 月 上海荣正企业咨询服务（集团）股份有限公司 关于 诺诚健华医药有限公司 2024 年科创板限制性股票激励计划 （草案） | 一、释义 | 2 | | --- | --- | | 二、声明 | 4 | | 三、基本假设 | 5 | | 四、本次限制性股票激励计划的主要内容 | 6 | | （一）激励对象的范围及分配情况 | 6 | | （二）授予的限制性股票数量 | 8 | | （三）股票来源 | 8 | | （四）限制性股票的有效期、授予日及授予后相关时间安排 | 8 | | （五）限制性股票授予价格 | 11 | | （六）激励计划的授予及归属条件 | 11 | | （七）激励计划其他内容 | 16 | | 五、独立财务顾问意见 | 16 | | （一）对限制性股票激励计划是否符合政策法规规定的核查意见 | 16 | | （二）对公司实行股权激励计划可行性的核查意见 | 17 | | （三）对激励对象范围和资格的核查意见 | 18 | | （四）对股权激励计划权益授出额度的核查意见 | 18 | ...

诺诚健华医药有限公司 2024 年科创板限制性股票激励计划实施考核管理办法 诺诚健华医药有限公司（以下简称"公司"）为进一步健全公司的激励约束机 制，形成良好均衡的价值分配体系，充分调动公司员工的积极性，使其更诚信勤 勉地开展工作，以保证公司业绩稳步提升，确保公司发展战略和经营目标的实现， 公司拟实施2024年科创板限制性股票激励计划（以下简称"本激励计划"）。 为保证本激励计划的顺利实施，现根据《中华人民共和国证券法》《上市公 司股权激励管理办法》《上海证券交易所科创板股票上市规则》《科创板上市公 司自律监管指南第4号——股权激励信息披露》《香港联合交易所有限公司证券 上市规则》等有关法律、法规和规范性文件、公司章程以及本激励计划的相关规 定，并结合公司的实际情况，特制定本办法。 一、考核目的 进一步完善公司激励约束机制，保证本激励计划的顺利实施，并在最大程度 上发挥股权激励的作用，进而确保公司发展战略和经营目标的实现。 二、考核原则 考核评价必须坚持公正、公开、公平的原则，严格按照本办法和考核对象的 业绩进行评价，以实现本激励计划与激励对象工作业绩、贡献紧密结合，从而提 高公司整体业绩，实现公司与全体股东 ...

Core Insights - The company successfully held its 2024 R&D Day, focusing on "Science-Driven Innovation" and showcasing advancements in autoimmune disease research, aiming to establish a second growth curve in this area [1] Group 1: Company Performance and Outlook - The company reported outstanding Q3 performance with accelerated commercialization growth, achieving the highest quarterly revenue for its core product, Oubatinib, since its launch [2] - The CEO highlighted breakthroughs in autoimmune disease research, with six indications poised for development, and projected five to six innovative drugs to be approved in the next three to five years, aligning with the company's 2.0 development goals [2] Group 2: Market Potential and Strategy - The CFO discussed the vast market potential for autoimmune diseases, with a forecasted global market size of $176 billion by 2030, indicating significant growth opportunities compared to the oncology market [2] - The company is strategically focusing on six autoimmune indications to create a solid foundation for future growth [2] Group 3: Research and Development Progress - The company employs a "pipeline-in-a-pill" strategy to maximize drug value, with Oubatinib targeting both peripheral and central nervous systems for various autoimmune indications [2] - Oubatinib is undergoing global Phase III clinical trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [2] - The company is advancing Oubatinib for the treatment of immune thrombocytopenia (ITP), with promising results from Phase II trials [2][3] Group 4: New Drug Developments - New oral TYK2 inhibitors, ICP-332 and ICP-488, are showing effectiveness in treating moderate to severe atopic dermatitis and psoriasis, respectively, with positive results from Phase II clinical studies [3] - The company is enhancing its drug discovery platform to develop innovative small and large molecule therapies for autoimmune diseases [3] Group 5: Business Development Strategy - The company is pursuing a flexible business development strategy to foster global collaborations and maximize the value of its pipeline through various partnership opportunities [3]

Investment Rating - The report assigns an "Accumulate" rating for the company [1]. Core Views - The company is entering a rapid growth phase with significant potential in the NHL and autoimmune drug markets, particularly with the BTK inhibitor applications [3][4]. - The management team is experienced and has established an integrated R&D and production platform, with a focus on innovative drug development [4][18]. - The company has a robust pipeline with 13 drugs in development and has achieved rapid revenue growth driven by its lead product, Aobutini [5][60]. Summary by Sections Company Overview - The company is a comprehensive innovative biotech firm focused on oncology and autoimmune diseases, with a fully integrated biopharmaceutical platform [18]. - Founded in 2015, the company has developed a strong R&D capability and has multiple promising drug candidates [18]. Management and Shareholder Structure - The company has a dispersed shareholding structure with no controlling shareholder, ensuring diverse governance [20]. R&D and Clinical Development - The company has established six core technology platforms for drug development and has over 30 clinical trials ongoing globally [53]. - Aobutini, the lead product, has shown significant market potential with multiple approved indications and rapid sales growth [60]. Financial Performance - The company has shown a significant increase in revenue, with projected revenues of 1.051 billion, 1.232 billion, and 1.433 billion yuan for 2024, 2025, and 2026 respectively [6]. - The net loss has narrowed, indicating improving profitability, with a forecasted EPS of -0.20 yuan for 2024 [6][5]. Market Potential - The NHL market is expected to grow significantly, with the number of patients in China projected to reach 730,000 by 2030 [3][69]. - BTK inhibitors are increasingly replacing traditional chemotherapy in NHL treatment, indicating a shift in treatment paradigms [71]. Investment Recommendations - The report suggests that Aobutini has substantial growth potential in the hematological malignancy indications, supporting the "Accumulate" rating [5].

Investment Rating - The report maintains a "Buy" rating for the Hong Kong stock of the company and adjusts the target price to HKD 9.2, indicating a potential upside of 23% from the current price of HKD 7.5 [2][4][12] - The A-share target price is raised to RMB 14.5, but the rating is downgraded to "Hold" due to the stock being in a reasonable valuation range [2][4][6] Core Insights - The company has raised its full-year sales guidance for the drug Orelabrutinib to a growth rate of 45% year-on-year, driven by strong sales performance and new indications being added to insurance coverage [3][4] - In Q3 2024, the company reported a significant narrowing of net losses to RMB 13.57 million, a decrease of 87.5% year-on-year, attributed to better-than-expected R&D expenses and favorable foreign exchange gains [2][3] - The company achieved revenue of RMB 278 million in Q3 2024, representing a 74% year-on-year increase, with Orelabrutinib sales contributing RMB 276 million, up 75.5% year-on-year [2][3] Financial Performance Summary - For the first nine months of 2024, total revenue reached RMB 698 million, a 29.8% increase year-on-year, with Orelabrutinib product revenue at RMB 693 million, up 45% year-on-year [2][3] - The gross margin improved to 86% compared to 81.2% in the same period last year, while the net loss attributable to shareholders for the nine months was RMB 275 million, down 53.7% year-on-year [2][3] - The company forecasts total revenue for 2024 to be RMB 989 million, with a projected growth rate of 34% year-on-year [7][10] Clinical Development and Pipeline - The company is advancing two TYK2 inhibitors for autoimmune indications, with clinical trials for ICP-332 and ICP-488 progressing as planned [4][6] - The management expects Orelabrutinib's overseas potential for progressive multifocal leukoencephalopathy (PML) indications to reach approximately USD 3 billion in sales [3][4] - Clinical trials for the ITP indication are expected to complete by 2025, with ongoing discussions with the FDA for other indications [3][4]

Group 1: Clinical Development Progress - The FDA has reached an agreement with the company to initiate Phase III clinical trials for Obechizumab in patients with Primary Progressive Multiple Sclerosis (PPMS) and has recommended starting a second Phase III trial for Secondary Progressive Multiple Sclerosis (SPMS) [2] - The company is currently conducting an international Phase III clinical trial for PPMS and preparing the SPMS Phase III clinical trial protocol [2] Group 2: Product Development and Results - ICP-488 has completed a Phase II clinical trial for psoriasis in China, showing significant improvement in the Psoriasis Area and Severity Index (PASI) scores, with at least a 75% reduction in PASI scores at week 12 for patients treated with 6mg and 9mg doses compared to placebo [3] - The proportion of patients achieving PASI 90 and PASI 100 was significantly higher in the treatment group compared to the placebo group [3] Group 3: Financial Performance - The company's gross margin for the first nine months of 2024 is 86.0%, an increase of 4.8 percentage points from 81.2% in the same period last year [3] - Obechizumab generated sales revenue of 276 million yuan in Q3 2024, a year-on-year increase of 75.5%, with total sales revenue of 693 million yuan for the first nine months of 2024, reflecting a growth of 45.0% [4] Group 4: Market Expansion and Future Prospects - Obechizumab has received insurance coverage for three indications, including Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL), making it the first and only BTK inhibitor approved for MZL in China [4] - The company aims to achieve at least six commercialized products by 2028, including Tafasitamab and ICP-488 for autoimmune disease indications [5]

Financial Performance - Core product Orelabrutinib (Yinokai®) achieved sales revenue of CNY 276 million in Q3 2024, a year-on-year increase of 75.5%[2] - Total revenue for the first nine months of 2024 reached CNY 698 million, representing a growth of 29.8% compared to the same period last year[4] - Gross profit margin for the first nine months of 2024 was 86.0%, up 4.8 percentage points from 81.2% in the same period last year[2] - The net loss for the first nine months of 2024 was CNY 285 million, narrowing by 47.1% compared to the previous year[2] - Total operating revenue for the first three quarters of 2024 reached CNY 697.75 million, a 30% increase from CNY 537.36 million in the same period of 2023[14] - The net loss for the third quarter of 2024 was CNY 285.32 million, compared to a net loss of CNY 539.29 million in the same quarter of 2023, showing an improvement of 47%[16] Cash and Assets - Cash and cash equivalents as of September 30, 2024, amounted to approximately CNY 7.8 billion, providing a solid financial foundation for ongoing projects[4] - Cash and cash equivalents decreased to CNY 6.84 billion from CNY 8.29 billion, a decline of approximately 17.4%[12] - The company’s total assets as of September 30, 2024, were CNY 9.46 billion, a decrease of 4.66% from the end of the previous year[4] - Total cash and cash equivalents at the end of Q3 2024 were 4,949,637,182.02 RMB, down from 5,440,243,367.28 RMB at the end of Q3 2023[18] Research and Development - Research and development expenses for Q3 2024 totaled CNY 194 million, accounting for 69.63% of revenue, a decrease of 48.34 percentage points year-on-year[4] - Research and development expenses accounted for 48.34% of operating revenue in the current reporting period, a decrease of 48.34 percentage points compared to the same period last year, primarily due to a significant increase in operating revenue[7] - Research and development expenses increased to CNY 614.98 million, up from CNY 549.72 million, indicating a growth of 11.9% year-over-year[14] - The company plans to continue focusing on R&D and market expansion strategies to enhance future growth prospects[16] Shareholder Information - The total number of ordinary shareholders as of the reporting period end was 1,762,567,202 shares, with 84.89% listed in Hong Kong[8] - HKSCC NOMINEES LIMITED held 857,691,175 shares, accounting for 48.66% of total shares[9] - HHLR Fund, L.P. and its concerted parties held 208,671,222 shares, representing 11.84% of total shares[9] - King Bridge Investments Limited and its concerted parties held 158,588,612 shares, which is 8.99% of total shares[9] Financial Liabilities and Expenses - The company reported a total liability of CNY 2.64 billion, slightly down from CNY 2.74 billion, indicating a reduction of approximately 3.6%[13] - The company’s equity attributable to shareholders decreased to CNY 6.80 billion from CNY 7.15 billion, a decline of about 5.2%[13] - The company reported a foreign exchange loss of 120.03 million year-to-date, which is an increase compared to the previous year[7] - The company’s financial expenses turned positive, showing a gain of CNY 147.53 million compared to a loss of CNY 35.90 million in the previous year[14] Cash Flow Activities - Net cash flow from operating activities was -333,136,181.63 RMB, an improvement from -446,143,350.48 RMB in the same period last year[17] - Cash inflow from investment activities totaled 4,648,580,477.88 RMB, slightly down from 4,686,238,569.10 RMB in Q3 2023[17] - Cash flow from financing activities resulted in a net outflow of -261,692,786.26 RMB, a decrease from a net inflow of 7,832,072.06 RMB in Q3 2023[18] - The company received 1,065,300,000.00 RMB in cash from borrowings, a significant increase from 27,200,000.00 RMB in the same period last year[18]

Fund Utilization - The net proceeds from the global offering amount to approximately HKD 2,415.67 million, with about HKD 1,568.33 million (64.9%) already utilized[4] - 50% of the utilized funds are allocated for clinical trials and potential commercial launch of Orelabrutinib in China and the US, with an expected full utilization by the second half of 2026[5] - 40% of the funds are designated for other clinical candidates, with full utilization expected by the second half of 2026[5] - 10% of the funds are for working capital and general corporate purposes, with full utilization expected by the second half of 2026[5] - The company has received approximately HKD 3,041.44 million from subscription agreements, with about HKD 1,967.09 million (64.7%) already utilized[7] - Funds from the subscription are intended for R&D costs, talent acquisition, and operational expenses, with all remaining funds expected to be utilized by 2027[8] - The company plans to enhance its capabilities in discovery, clinical, business development, and commercialization through talent acquisition, with an allocation of HKD 672.77 million[8] - The company reserves funds for potential external collaborations and licensing opportunities, amounting to HKD 273.63 million[8] - The total amount of subscription proceeds is HKD 3,041.44 million, with HKD 1,074.35 million remaining unutilized[8] - Any unutilized proceeds may be temporarily invested in financial products with a maturity of no more than 12 months, in accordance with the company's best interests[9] Financial Performance - The company's core product, Oubatinib (Yinokai®), achieved sales revenue of RMB 276 million in Q3 2024, representing a year-on-year growth of 75.5%[14] - For the first nine months of 2024, total revenue reached RMB 698 million, an increase of 29.8% compared to the same period last year[14] - The gross profit margin for the first nine months of 2024 was 86.0%, up from 81.2% in the same period last year, reflecting an improvement of 4.8 percentage points[14] - The net loss for the first nine months of 2024 was RMB 285 million, a reduction of 47.1% compared to the previous year[14] - The company's operating revenue for the current reporting period increased by 73.96% compared to the same period last year[19] - Pharmaceutical sales revenue for the current reporting period rose by 76.30%, primarily due to the continuous increase in sales volume of Oubutini[19] - The total amount of non-recurring gains and losses for the current period was 938,089.74 RMB, while the cumulative amount from the beginning of the year to the end of the reporting period was -8,323,549.99 RMB[18] - The company reported a net profit attributable to shareholders of the listed company for the current period, with specific figures not disclosed in the summary[20] - The company recognized a loss of 5,946,104.68 RMB in other non-recurring gains and losses, primarily related to the fair value changes of convertible loans issued by the group[18] - The company received government subsidies amounting to 958,038.57 RMB during the current period, contributing to its financial performance[18] Assets and Liabilities - As of September 30, 2024, the company held approximately RMB 7.8 billion in cash and cash equivalents, ensuring sufficient liquidity for ongoing projects[16] - The total assets as of the end of the reporting period were RMB 9.46 billion, a decrease of 4.66% from the previous year-end[16] - The equity attributable to shareholders of the listed company was RMB 6.80 billion, down 4.88% from the previous year-end[16] - The total liabilities as of September 30, 2024, were ¥2,635,567,475.81, slightly down from ¥2,739,290,198.68 at the end of 2023, a decrease of about 3.8%[26] - The company’s total equity decreased to ¥6,822,030,630.95 as of September 30, 2024, from ¥7,180,705,653.78 at the end of 2023, a decline of about 5%[26] Research and Development - Research and development expenses for Q3 2024 totaled RMB 194 million, accounting for 69.63% of revenue, a decrease of 48.34 percentage points year-on-year[16] - Research and development expenses as a percentage of operating revenue decreased by 48.34 percentage points in the current reporting period due to a significant increase in operating revenue compared to the previous year[20] - Research and development expenses increased to ¥614,983,375.71 in 2024, compared to ¥549,716,988.65 in 2023, indicating a rise of approximately 11.8%[27] - The company experienced a decrease of 14.16 percentage points in R&D expenses as a percentage of operating revenue from the beginning of the year to the end of the reporting period[20] Cash Flow - Cash and cash equivalents as of September 30, 2024, were ¥6,839,240,725.79, down from ¥8,287,136,644.81 at the end of 2023, a decrease of about 17.4%[25] - The net cash flow from financing activities was -261,692,786.26 CNY in Q3 2024, compared to a positive cash flow of 7,832,072.06 CNY in Q3 2023[31] - Cash flow from operating activities was -333,136,181.63 CNY for the first three quarters of 2024, an improvement from -446,143,350.48 CNY in the same period of 2023[30] - The company reported cash inflow from investment activities of 4,648,580,477.88 CNY in the first three quarters of 2024, slightly down from 4,686,238,569.10 CNY in 2023[30] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 16,139, with the top ten shareholders holding a total of 1,328,000,000 shares, accounting for approximately 75.4% of the total shares[22] - The total number of shares issued by the company was 1,762,567,202, with 84.89% listed in Hong Kong and 15.11% on the Shanghai Stock Exchange[21]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2024年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 諾誠健華醫藥有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2024年11月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | 本月 ...

| A | A 股简称：诺诚健华 公告编号：2024-030 | 股代码：688428 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 关于召开 2024 年第三季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 11 月 12 日(星期二)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/） 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 11 月 5 日(星期二)至 11 月 11 日(星期一)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.com 进行提问。公司将在说明会上对投资者普遍关注的问题 进行回答 诺诚健华医药有限公司（以下简称"公司"）将于 2024 年 11 月 12 日发布公 ...