关于诺诚健华医药有限公司 首次公开发行战略配售限售股上市流通的核查意见 中国国际金融股份有限公司作为诺诚健华医药有限公司（以下简称"诺诚健华"或 "公司"）首次公开发行人民币普通股（A 股）股票并在科创板上市的保荐机构，根据 《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票上市规则》和《上海 证券交易所上市公司自律监管指引第 11 号——持续督导》等法律、行政法规、部门规 章及业务规则，对公司首次公开发行战略配售限售股上市流通的事项进行了认真、审慎 的核查，核查情况如下： 一、本次上市流通的限售股类型 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，并于 2022 年 9 月 21 日在上海证券交易所科创板上市。本次发行上市后公司已发行股 ...

| 股代码：688428 | A 股简称：诺诚健华 公告编号：2023-027 | A | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 首次公开发行战略配售限售股上市流通公告 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。 重要内容提示： 本次上市流通的战略配售股份数量为 14,415,229 股，限售期为自诺诚健 华医药有限公司（以下简称"公司"或"诺诚健华"）首次公开发行人民币普通股（A 股）股票并在科创板上市（以下简称"本次发行上市"）之日起 12 个月。本公司 确认，上市流通数量为该限售期的全部战略配售股份数量 本次限售股上市流通日期为 2023 年 9 月 21 日 一、 本次上市流通的限售股类型 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 ...

（股份代號：9969） 自願公告 場內股份回購 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （於開曼群島註冊成立的有限公司） 股份回購計劃 根據股東在本公司於二零二三年六月二日舉行的股東週年大會上通過的決議案， 董事獲授一般無條件授權可購回最多149,967,323股港股（四捨五入至最接近整數） （「購回授權」）。購回授權的詳情載於本公司日期為二零二三年五月三日的通函。 本公司將遵照本公司第三次經修訂及重訂之組織章程大綱及章程細則、上市規 則、公司收購、合併及股份回購守則、開曼群島公司法及本公司須遵守之所有適 用法律及規例行使購回授權。 本公司隨後將註銷回購的港股。 本公司股東及潛在投資者應注意，根據股份回購計劃可能進行的任何港股回購均 受市場條件規限，並由董事會全權酌情決定。概不保證股份回購的時間、數量或 價格。因此，股東及潛在投資者於買賣股份時務須審慎行事。 承董事會命 諾 ...

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: 2023年8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: 2023年9月4日 I. 法定/註冊股本變動 FF301 | 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 | 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 | 本月底法定/註冊股本 ...

FANGDA PARTNERS 上海 Shanghai·北京 Beijing·深圳 Shenzhen·广州 Guangzhou·香港 Hong Kong http://www.fangdalaw.com 邮政编码：200041 传 真 Fax: 86-21-5298 5599 中国上海市石门一路 288 号 电子邮件 E-mail: email@fangdalaw.com 兴业太古汇香港兴业中心二座 24 楼 电 话 Tel.: 86-21-2208 1166 24/F, HKRI Centre Two HKRI Taikoo Hui 288 Shi Men Yi Road Shanghai 200041, PRC 诺诚健华医药有限公司（InnoCare Pharma Limited） 2023 年第一次临时股东大会（股东特别大会） 的 法律意见书 致：诺诚健华医药有限公司（InnoCare Pharma Limited） 上海市方达律师事务所（以下简称"本所"）是具有中华人民共和国法律执业资 格的律师事务所。根据相关法律顾问协议，本所指派律师出席诺诚健华医药有限公 司（InnoCare Pharma Lim ...

| | | 诺诚健华医药有限公司 2023 年第一次临时股东大会（股东特别大会） 决议公告 本公司董事会及全体董事保证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。 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2023 年 8 月 31 日 （二） 股东大会召开的地点：北京市昌平区中关村生命科学园生命园路 8 号院 8 号楼 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 33 | | --- | --- | | 普通股股东人数 | 33 | | 其中：A 股股东人数 | 19 | | 境外上市外资股股东人数 | 14 | | 2、出席会议的股东所持有的表决权数量 | 822,158,141 | | 普通股股东所持有表决权数量 | 822,158,141 | | 其中：A 股股东所持有表决权数量 | 22,843,988 | | --- | --- | | 境外上市外资股股东所持有表决权数量 | 799,314,153 | ...

Financial Performance - The company reported a net loss of RMB 429 million for the first half of 2023, an improvement compared to a net loss of RMB 446 million in the same period last year, indicating a narrowing of losses [4]. - Excluding non-cash items, the adjusted net loss was RMB 206 million, compared to RMB 225 million in the previous year, also reflecting a reduction in losses [4]. - The company has not proposed any profit distribution or capital reserve transfer plans for this reporting period [5]. - The financial report for the first half of 2023 has not been audited [5]. - The company reported a net income of $80 million for the first half of 2023, a 40% increase compared to the same period last year [15]. - The net profit attributable to shareholders for the same period was a loss of CNY 422,209,548.49, slightly improved from a loss of CNY 441,343,044.79 in the previous year [22]. - The net cash flow from operating activities decreased to CNY -309,583,217.71, primarily due to increased personnel costs from expanded operations and R&D services [22]. - The gross margin for the first half of 2023 improved to 60%, up from 55% in the previous year, reflecting better cost management [15]. - The company reported a total R&D investment of ¥361,193,556.11 for the current period, representing a 29.79% increase compared to ¥278,301,098.36 in the same period last year [125]. - The R&D investment accounted for 95.67% of the operating revenue, a decrease of 17.48 percentage points from 113.15% in the previous year [125]. Research and Development - The company continues to invest heavily in drug discovery, preclinical research, clinical development, registration, production, and commercialization, which are long-cycle and high-risk processes [4]. - The company remains committed to its research and development capabilities as a core driver of growth [4]. - The company plans to increase its R&D budget by 10% in 2024 to support ongoing clinical trials and product development [15]. - The company has established a biomarker-based translational medicine research platform to enhance drug development efficiency [130]. - The company has established multiple core technology platforms, including compound optimization and drug solubility enhancement, to accelerate drug discovery and development [120]. - The company has 13 products in various stages of clinical trials (I/II/III), with significant progress in the US and China [130]. - The company is actively developing multiple products for autoimmune diseases, leveraging its expertise in B-cell and T-cell dysfunction [136]. - The company is exploring various combination therapies for DLBCL, aiming to provide effective treatment options for patients [27]. - The company is conducting multiple registrational clinical trials for Obutinib in both domestic and international markets [49]. Product Development and Pipeline - The company focuses on developing innovative drugs for oncology and autoimmune diseases, addressing significant unmet clinical needs in the global market [4]. - The core product, Acalabrutinib (Ibrutinib), achieved sales of RMB 321 million in the first half of 2023, representing a year-on-year growth of 47.81% [28]. - The company aims to establish a leadership position in the hematological oncology field, targeting NHL, MM, and leukemia with a comprehensive pipeline of investigational drugs [27]. - The company is conducting a Phase III clinical trial for Acalabrutinib in first-line treatment of CLL/SLL, with patient recruitment completed in the first half of 2023, and plans to submit an NDA in 2024 [28]. - The company is also advancing ICP-248, a novel oral BCL2 inhibitor, which has shown promising preliminary results in a Phase I trial, with plans to submit an IND application in the U.S. by the end of this year [30]. - The company is developing multiple therapies targeting B-cell and T-cell signaling pathways for autoimmune diseases, addressing unmet clinical needs [34]. - The company has a robust pipeline with significant clinical application value in solid tumors, focusing on innovative therapies for B-cell and T-cell signaling pathways in autoimmune diseases [116]. Market Expansion and Strategy - The company reported a significant increase in revenue for the first half of 2023, reaching $500 million, representing a 25% growth year-over-year [15]. - User data showed an increase in active users to 2 million, up from 1.5 million in the previous year, indicating a 33% growth [15]. - The company provided guidance for the second half of 2023, projecting revenue to reach between $600 million and $650 million, which would represent a growth of 20% to 30% compared to the same period last year [15]. - New product launches are expected to contribute an additional $100 million in revenue by the end of 2023, with a focus on innovative therapies targeting specific cancers [15]. - The company is expanding its market presence in Asia, aiming to increase market share by 15% in the region by the end of 2023 [15]. - A strategic acquisition of a biotech firm was announced, expected to enhance the company's R&D capabilities and add $50 million in annual revenue [15]. Regulatory and Compliance - The report includes forward-looking statements regarding industry trends and the company's future development plans, emphasizing the associated risks and uncertainties [7]. - The company operates as a red-chip enterprise, with governance structures differing from typical domestic A-share listed companies [5]. - The company is exposed to risks from rapid technological changes and competition from other pharmaceutical and biotech companies that may develop superior products [146]. - The company must maintain significant R&D investments to ensure technological advantages and mitigate risks of core technology leakage [147]. - The company is subject to compliance with the laws and regulations of multiple jurisdictions, including the Cayman Islands, China, the US, Australia, and Hong Kong [195]. - The company faces compliance risks related to anti-kickback, anti-fraud, and privacy protection laws, which could affect its operations if violated [198]. Challenges and Risks - The company has not yet achieved profitability and expects to continue incurring cumulative losses in the near future due to high R&D costs and ongoing clinical trials [140]. - The company faces risks related to the successful identification of new drug candidates and the progress of clinical trials, which may lead to delays and increased costs [142]. - The complexity and high costs associated with new drug development pose significant challenges, including long R&D cycles and uncertain outcomes [179]. - Difficulties in patient recruitment and management for clinical trials could delay progress and increase costs, impacting the development of in-progress products [180]. - The company may face legal disputes if clinical trial participants suffer harm due to its investigational products, which could lead to financial liabilities [150]. - The company faces potential revenue decline due to government price negotiations and procurement policies, which may negatively impact future drug income [166].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：9969) 截至二零二三年六月三十日止六個月 中期業績公告 諾誠健華醫藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事（「董 事」）會（「董事會」）欣然公佈本集團截至二零二三年六月三十日止六個月（「報告 期」）之未經審計綜合業績，連同截至二零二二年六月三十日止六個月之比較數 字。 在本公告內，「我們」及「我們的」均指本公司，如文義另有所指，則指本集團。 本公告所載若干金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數 （如適用）。任何表格、圖表或其他地方所示總額與所列數額總和如有任何差異乃 因四捨五入所致。除另有界定外，本公告所使用詞彙與招股章程已界定者具有相 同涵義。 1 財務摘要 | | 截至六月三十日止六個月 | | | --- | --- | --- | | | 二 ...

Revenue and Financial Performance - Revenue increased from RMB 245.96 million in the six months ended June 30, 2022, to RMB 377.55 million in the six months ended June 30, 2023, representing a growth of 53.5%[2]. - Total revenue for the six months ended June 30, 2023, was RMB 377.5 million, with sales of Orelabrutinib reaching RMB 320.7 million, a 47.8% increase compared to the same period in 2022[27]. - Drug sales net revenue rose by RMB 104.4 million or 48.1% to RMB 321.5 million in the six months ended June 30, 2023[109]. - The gross profit for the same period was RMB 301.48 million, compared to RMB 183.22 million in the previous year, indicating a significant improvement[166]. - The company incurred a loss before tax of RMB 429.18 million for the six months ended June 30, 2023, slightly improved from a loss of RMB 445.81 million in the same period of 2022[166]. - The group reported a loss of RMB 422,211,000 for the six months ended June 30, 2023, compared to a loss of RMB 441,343,000 for the same period in 2022, indicating a decrease in losses of approximately 2.6%[193]. - Other income and gains for the six months ended June 30, 2023, amounted to RMB 131,265 thousand, compared to RMB 99,292 thousand in 2022, representing an increase of approximately 32.2%[183]. Research and Development - The company is advancing a strong pipeline of 13 valuable drugs, including 2 commercialized products and over 30 ongoing global trials[7]. - Research and development expenses increased from RMB 273.5 million to RMB 358.1 million due to expanded clinical trials[6]. - The company aims to establish a leading position in the hematological oncology field, focusing on therapies for non-Hodgkin lymphoma, multiple myeloma, and leukemia[8]. - The company is actively pursuing clinical development for Obinutuzumab in treating autoimmune diseases, with a focus on ITP and SLE[105]. - The company plans to enhance its pipeline through licensing and clinical collaboration opportunities[107]. - The company is building internal capabilities for biopharmaceutical R&D to become a leading global biopharmaceutical company[108]. Clinical Trials and Drug Development - Patient recruitment for the registration trial of Ibrutinib as a first-line treatment for CLL/SLL was successfully completed in the first half of 2023, with an NDA submission expected in mid-2024[10]. - The registration phase II trial for relapsed/refractory Mantle Cell Lymphoma (MCL) in the U.S. was completed in the first half of 2023, with an NDA submission anticipated in mid-2024[11]. - The ongoing Phase II registration trial for ICP-723 in advanced solid tumors has shown an overall response rate (ORR) exceeding 80%-90% in patients with NTRK gene fusions[18]. - The company is exploring the combination therapy of Obinutuzumab with Tafasitamab/Lenalidomide for potential treatment in NHL, with a Phase II clinical trial initiated in China[43]. - The ongoing Phase II key trial of Tafasitamab combined with lenalidomide for treating relapsed/refractory DLBCL is expected to yield data within the next 6 months, with an NDA submission planned for H1 2024 in mainland China[45]. Financial Position and Assets - Total assets as of June 30, 2023, were RMB 9,111.41 million, with total liabilities of RMB 2,073.18 million, resulting in a net asset value of RMB 7,502.53 million[170]. - The company's cash and bank balances stood at RMB 8,367.07 million as of June 30, 2023, down from RMB 8,697.93 million at the end of 2022[169]. - Trade receivables increased from RMB 127.8 million to RMB 209.3 million[123]. - Inventory increased from RMB 653 million as of December 31, 2022, to RMB 1,095 million as of June 30, 2023, indicating a significant preparation for future sales growth[129]. - The company's debt-to-asset ratio as of June 30, 2023, was 19.6%, an increase from 18.8% as of December 31, 2022[146]. Corporate Governance and Compliance - The company has adopted the corporate governance code and believes its current structure does not impair the balance of power between the board and management[154]. - The audit committee, consisting of two independent non-executive directors and one non-executive director, has reviewed the interim results and financial statements for the six months ended June 30, 2023[158]. - The company has confirmed compliance with the standard code for securities transactions by all directors for the six months ended June 30, 2023[155]. - The company will continue to review its corporate governance practices to ensure compliance with the highest standards[154]. Market and Sales Strategy - The company expects to drive sales growth for Orelabrutinib through expanded indications and enhanced commercialization capabilities[27]. - The sales coverage of Orelabrutinib has rapidly penetrated core cities and leading hospitals globally, supported by a team of approximately 330 experienced sales and marketing personnel[27]. - The company aims to address unmet clinical needs in autoimmune diseases through innovative oral drug solutions targeting B and T cell pathways[56]. - The company plans to fully utilize the raised funds for new drug research and development, upgrading drug development platforms, and building marketing networks by 2027, subject to market conditions[165].

独立非执行董事 ：陈凯先、胡兰 2023 年 8 月 29 日 根据公司章程及《上市公司独立董事规则》的有关规定，依据诺诚健华医药 有限公司（以下简称"公司"）提供的会议材料说明，我们作为公司的独立非执 行董事，本着对公司及全体股东负责的态度，按照实事求是的原则，基于独立判 断的立场，针对《2023 年半年度募集资金存放与实际使用情况的专项报告》，发 表如下独立意见： 2023 年上半年，公司已按《上市公司监管指引第 2 号——上市公司募集资 金管理和使用的监管要求》《上海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》及公司制定的《A 股募集资金管理办法》的相关规定及时、真 实、准确、完整披露募集资金的存放与使用情况。公司募集资金存放、使用及披 露不存在违规情形,亦不存在改变或变相改变募集资金投资项目及损害股东利益 的情况。我们同意《2023 年半年度募集资金存放与实际使用情况的专项报告》。 诺诚健华医药有限公司 独立非执行董事关于公司董事会会议相关议案的独立意见 ...