2024年4月28日 公司深 度研究 公 买入 / 首次 司 诺诚健华(688428.SH) 研 究 目标价:16.10 0.00 昨收盘:8.32 血液瘤先发优势稳固，自免管线收获期临近  走势比较 报告摘要 10% 诺诚健华（688428.SH）是一家商业化阶段的生物医药公司，2015年成立 太 平 (( 12 4% %))72/4/32 9/7/32 02/9/32 2/21/32 31/2/42 62/4/42 至 瘤今 、， 自免2 款 疾血 病及液瘤 实体产 瘤品已 。公获 司批 的上 推市 荐， 逻13 辑款 如产 下品 ：处 于临床阶段，覆盖血液 洋 (26%)  奥布替尼有望保持快速放量，坦昔妥单抗将贡献新增量 证 (38%) 1） 中国 NHL 患者五年生存率仍与发达国家存在较大差距，未满足 券 (50%) 临床需求巨大； 股 份 诺诚健华 沪深300 2） 奥布替尼适应症增加和出海预期：奥布替尼获批的3项适应症均 已纳入国家医保； 4 项中国注册性 3 期临床（1L CLL/SLL，r/r 有  股票数据 MZL，1L MCL，1L MCD DLBCL）正在进行中，有望于2024- ...

InnoCare Pharma Limited 諾誠健華醫藥有限公司 股份代號：9969 （於開曼群島註冊成立的有限公司） 年度報告 目錄 諾誠健華醫藥有限公司 2023年度報告 在本報告內，除文義另有所指外，以下詞彙具有下列涵義。該等詞彙及其定義未必與任何業內標準定義 相符，亦未必可直接與其他在本公司相同行業內經營的公司所採用的同類詞彙比較。 | 「AD」 | 指 | 特應性皮炎 | | --- | --- | --- | | 「股東週年大會」 | 指 | 本公司股東週年大會 | | 「ALL」 | 指 | 急性淋巴細胞白血病 | | 「AML」 | 指 | 急性髓性白血病 | | 「AQP4 IgG」 | 指 | 水通道蛋白4抗體 | | 「美國血液學會」或「ASH」 | 指 | 美國血液學會 | | 「澳元」 | 指 | 澳洲法定貨幣澳元 | | 「審核委員會」 | 指 | 董事會的審核委員會 | | 「B細胞」 | 指 | 一種因B細胞外表面存在B細胞受體而不同於T細胞等其他淋巴細 | | | | 胞的白細胞，亦稱B淋巴細胞 | | 「潤諾」 | 指 | BioDuro Inc.及其聯屬公司，包括上海 ...

InnoCare Pharma Limited 諾誠健華醫藥有限公司 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 環 境 ， 社 會 及 管 治 報 告 目 錄 諾誠健華醫藥有限公司 二零二三年環境、社會及管治(ESG)報告 | 報告編製說明 | | 2 | | --- | --- | --- | | 董事會主席致辭 | | 4 | | 1. 關於諾誠健華 | | 6 | | 1.1 | 公司概況 | 6 | | 1.2 | ESG管理 | 9 | | 1.3 | 實質性議題識別 | 11 | | 2. 公司治理責任 | | 14 | | 公司治理 | | | | 2.1 | | 14 | | 2.2 | 投資者權益保護 | 16 | | 2.3 | 風險管理與內部控制 | 17 | | 2.4 | 合規與商業道德 | 21 | | 3. 產品與服務責任 | | 24 | | 3.1 | 研發與創新 | 24 | | 3.2 | 全過程質量管理 | 30 | | 3.3 | 客戶權益保護 | 36 | | 3.4 | 供應鏈管理 ...

此乃要件 請即處理 閣下如對本通函任何方面或應採取的行動有任何疑問，應諮詢股票經紀或其他註冊證券交易商、銀行經理、 律師、專業會計師或其他專業顧問。 閣下如已將名下所有諾誠健華醫藥有限公司的股份出售或轉讓，應立即將本通函交予買主或承讓人或經手 買賣的銀行、股票經紀或其他代理商，以便轉交買主或承讓人。 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通函的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不就本通函全部或任何部分內容而產生或因倚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） (1) 二零二三年年度報告； (5) 建議重選退任董事； (8) 建議提供擔保； (9) 建議修訂現有組織章程大綱及章程細則； 及 (10) 股東週年大會通告 諾誠健華醫藥有限公司謹訂於二零二四年六月二十七日（星期四）下午三時正假座中國北京市昌平區中 關村生命科學園生命園路8號 院8號樓舉行股東週年大會，大會通告載於本通函第AGM-1至AGM-8頁。 隨 ...

| A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-009 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于召开 2024 年股东周年大会的通知 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。 重要内容提示： 一、 召开会议的基本情况 （一） 股东大会类型和届次 2024 年股东周年大会 召开日期时间：2024 年 6 月 27 日 15 点 00 分 召开地点：北京市昌平区中关村生命科学园生命园路 8 号院 8 号楼 （六） 融资融券、转融通、约定购回业务账户和沪股通投资者的投票程序 涉及融资融券、转融通业务、约定购回业务相关账户以及沪股通投资者的投 票，应按照《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》 等有关规定执行。 （五） 网络投票的系统、起止日期和投票时间。 网络投票系统：上海证券交易所股东大会网络投票系统 网络投票起止时间：自 2024 年 6 月 27 日 至 2024 年 6 月 ...

Financial Performance - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year, representing a 25% year-over-year growth[2]. - Total revenue increased by 18.1% from RMB 625.4 million in 2022 to RMB 738.5 million in 2023, primarily driven by the rapid growth in sales of Obinutuzumab[50]. - Gross profit rose by 26.6% from RMB 482.0 million in 2022 to RMB 610.1 million in 2023, with a gross margin of 82.6%, up from 77.1% in the previous year[51]. - Net loss decreased by 27.8% from RMB 893.7 million in 2022 to RMB 645.6 million in 2023[52]. - Other income and gains rose from RMB 198.2 million in 2022 to RMB 244.2 million in 2023, largely due to an increase in bank interest income[51]. - Total expenses decreased from RMB 1,550.5 million in 2022 to RMB 1,404.3 million in 2023, attributed to improved operational efficiency[51]. - Cash and bank balances as of December 31, 2023, were approximately RMB 8.22 billion, providing flexibility for clinical development and investment in competitive product lines[52]. Market Expansion and Product Development - The company provided guidance for the next fiscal year, projecting revenue growth of 20% to reach between $600 million and $720 million[2]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of the next fiscal year[2]. - New product launches included two innovative therapies, expected to contribute an additional $100 million in revenue over the next year[2]. - The company aims to establish leadership in the hematological oncology field through a robust pipeline and strategic drug development initiatives[30]. - The company plans to invest $50 million in digital marketing to enhance customer engagement and drive sales growth[2]. Research and Development - Research and development expenses increased to $80 million, accounting for 16% of total revenue, reflecting the company's commitment to innovation[2]. - The company has a strong pipeline with 13 valuable drug candidates, including 2 commercialized products and over 30 ongoing global trials at various clinical stages[29]. - The company is focused on advancing research in B-cell and T-cell pathways for autoimmune diseases, aiming to address unmet clinical needs[60]. - The company is actively developing new technologies such as PROTAC, XDC, and molecular glue to enhance its drug development capabilities[129]. Clinical Trials and Approvals - The company received regulatory approval for its lead drug candidate, which is expected to launch in Q3 of the next fiscal year[2]. - The new drug application for relapsed refractory marginal zone lymphoma (MZL) was approved in April 2023, making it the first and only approved BTK inhibitor for this indication in China[31]. - The company successfully completed patient recruitment for a Phase III registration trial for CLL/SLL first-line treatment in the first half of 2023, with NDA submission expected in the second half of 2024[31]. - The company is conducting a Phase III clinical trial for MCD subtype DLBCL, comparing Obinutuzumab combined with R-CHOP to R-CHOP alone, with patient recruitment ongoing at 45 clinical centers in China[32]. Strategic Acquisitions and Collaborations - The company announced a strategic acquisition of a biotech firm for $200 million, aimed at enhancing its product pipeline[2]. - The company is collaborating with ArriVent Biopharma to evaluate the combination therapy of ICP-189 with furmonertinib for advanced non-small cell lung cancer patients[125]. Financial Position and Investments - The company has a strong cash position with a total cash balance of RMB 8.2 billion at year-end, providing financial stability and flexibility[57]. - The company has completed the second phase of construction at its Guangzhou facility, adding 30,000 square meters to support ongoing drug development and business expansion[130]. - The company has a bank credit line of RMB 400 million, of which RMB 33.8 million has been drawn down, leaving RMB 366.2 million undrawn[174]. Governance and Management - The company has a strong board with members possessing extensive experience in the pharmaceutical and biotechnology industries, including investment management and academic leadership[185]. - The board's composition reflects a commitment to governance and oversight, with members serving on various committees such as audit, compensation, and nomination[185]. - The management team has a strong background in drug discovery and development, with over 30 years of experience in the pharmaceutical industry[189]. Future Outlook - The company aims to become a global leader in biopharmaceuticals by leveraging its robust R&D capabilities and diverse drug portfolio[192]. - The company plans to commercialize multiple innovative drugs in the coming years, enhancing global patient access to its therapies[61].

诺诚健华医药有限公司 关于诺诚健华医药有限公司 2023年度营业收入扣除情况专项说明 安永华明（2024）专字第70045495_A03号 诺诚健华医药有限公司 2023年度营业收入扣除情况专项说明 诺诚健华医药有限公司 目 录 | | 页 次 | | --- | --- | | 一、营业收入扣除情况专项说明 | 1 – 2 | | 二、营业收入扣除情况表 | 3 | 诺诚健华医药有限公司董事会： 我们接受委托，审计了诺诚健华医药有限公司的财务报表，包括2023年12月31日 的合并资产负债表、2023年度合并利润表、股东权益变动表和现金流量表以及相关财 务 报 表 附 注 ， 并 于 2024 年 3 月 28 日 出 具 了 编号为 安 永 华 明 （ 2024 ） 审 字 第 70045495_A01号的无保留意见审计报告。 根据《上海证券交易所科创板上市公司自律监管指南第9号——财务类退市指标： 营业收入扣除》的规定，诺诚健华医药有限公司编制了后附的2023年度营业收入扣除 情况表（以下简称"情况表"）。如实编制和对外披露情况表并确保其真实性、合法 性、完整性是诺诚健华医药有限公司管理层的责任。 基于 ...

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3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4月3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 | 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 ...

Financial Performance - The company reported a net loss of 646 million yuan for 2023, with a cash-adjusted loss of 491 million yuan after excluding non-cash items [3]. - The company does not plan to distribute profits for the 2023 fiscal year, pending approval at the shareholders' annual meeting [5]. - The company reported a revenue of RMB 1.2 billion for the fiscal year 2023, representing a year-over-year growth of 25% [13]. - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year 2023, representing a 25% year-over-year growth [18]. - The company's operating revenue for 2023 was ¥738,537,047.65, representing an 18.09% increase compared to ¥625,404,169.95 in 2022 [23]. - The net profit attributable to shareholders for 2023 was -¥631,262,907.71, an improvement from -¥886,593,114.73 in 2022 [23]. - The net cash flow from operating activities decreased to -¥665,489,513.23 in 2023 from -¥490,583,554.63 in 2022 [23]. - Basic and diluted earnings per share for 2023 were -¥0.37, compared to -¥0.60 in 2022 [24]. - The company reported a net loss attributable to shareholders of -¥100,097,399.14 in Q4 2023, following losses of -¥12,406,466.71 in Q1, -¥409,803,081.78 in Q2, and -¥108,955,960.08 in Q3 [26]. Research and Development - Research and development expenses increased by 16.73% year-on-year to 757 million yuan, reflecting ongoing investments in new technology platforms and clinical trials [3]. - The R&D investment for new products and technologies increased by 30%, totaling RMB 300 million in 2023 [13]. - Research and development expenses increased by 40%, totaling $80 million, to support new technology initiatives [18]. - Research and development expenses accounted for 102.53% of operating revenue in 2023, slightly down from 103.73% in 2022 [24]. - The company’s R&D investment was significantly high, reflecting its commitment to innovation despite the financial losses [24]. - The total R&D investment for the year reached ¥757,253,137.36, an increase of 16.73% compared to ¥648,702,607.78 in the previous year [145]. - The company has established four core technology platforms, including compound optimization and drug solubility enhancement, to accelerate drug discovery and development [141]. - The company has developed a highly efficient self-research platform covering early drug discovery to late clinical development, with 13 products in I/II/III clinical trial stages as of March 28, 2024 [151]. Product Pipeline and Market Strategy - The company has established a rich product pipeline in hematological malignancies, autoimmune diseases, and solid tumors, with its core product, Obinutuzumab, already commercialized [3]. - Tafasitamab has been approved in Hong Kong and is recognized as a clinically needed imported drug in the Greater Bay Area and Boao Super Hospital [3]. - The company plans to expand its market presence in Southeast Asia, targeting a 20% market share by 2025 [13]. - The company is expanding its market presence in Europe, targeting a 15% market share by the end of 2024 [18]. - The company launched two new drugs in Q4 2023, contributing to a 10% increase in overall sales [13]. - The company is actively pursuing market expansion and commercialization strategies, including partnerships with quality CMO for production support [32]. - The company aims to establish leadership in the hematological malignancies field, with a focus on covering NHL, MM, and leukemia using ibrutinib as a core therapy [56]. Clinical Trials and Drug Development - The company has 13 products in clinical trials across I/II/III phases, focusing on oncology and autoimmune diseases, with significant unmet clinical needs [31]. - Acalabrutinib has been included in the 2021 CSCO lymphoma diagnosis and treatment guidelines and is recommended for multiple indications, enhancing its market competitiveness [32]. - The company has initiated a Phase III clinical trial for Obinutuzumab in ITP, with the first patient enrolled in October 2023 and expected completion of recruitment by the end of 2024 or early 2025 [43]. - The company is conducting a Phase II clinical trial for Acalabrutinib in relapsed or refractory MCL in the U.S., with NDA submission anticipated in the second half of 2024 [35]. - Tafasitamab (Minjuvi®) is undergoing a bridging Phase II clinical trial for relapsed or refractory DLBCL in mainland China, with NDA submission expected in Q2 2024 and approval anticipated in the first half of 2025 [36]. - ICP-248, a novel oral BCL2 inhibitor, is in a Phase I dose-escalation trial, showing promising safety and efficacy data, with an ORR of 100% in evaluable patients at the 100 mg QD RP2D dose [38]. - The company has initiated a Phase III trial for ibrutinib in treating immune thrombocytopenia (ITP) patients, with promising proof of concept (PoC) data reported [80]. Market and Competitive Landscape - The global market for autoimmune disease treatments is projected to reach $185 billion by 2029, with a CAGR of 3.7%, driven by the increasing incidence of autoimmune diseases and rising treatment costs [42]. - The company faces significant competition in the market, with existing products and those in clinical trials posing risks to the market share of Obinutuzumab, particularly from competitors like Ibrutinib and Zepzelca, which were approved earlier in China [169]. - The global pharmaceutical market size reached $1,298.8 billion in 2020, projected to grow to $1,711.4 billion by 2025, with a CAGR of 5.7% from 2020 to 2025 [117]. - The global anti-tumor drug market grew from $93.7 billion in 2016 to $150.3 billion in 2020, with a CAGR of 12.5%, and is projected to reach $304.8 billion by 2025 [126]. - The company is committed to developing innovative therapies for autoimmune diseases through a differentiated approach targeting both B-cell and T-cell signaling pathways [80]. Risks and Challenges - There is a risk of continued losses in the future due to the lengthy and high-investment nature of drug development and commercialization processes [3]. - The company warns that if its in-development drugs fail to complete clinical trials or gain regulatory approval, it may not achieve profitability, impacting its operational capabilities [3]. - The company faces challenges in new drug development, including high R&D costs, long development cycles, and the complexity of clinical trial patient recruitment [136]. - The company must comply with various legal and regulatory requirements in multiple jurisdictions, including the Cayman Islands and China, which may impact its operations and financial status [200]. - The company is exposed to risks from third-party collaborations, including potential delays in clinical trials and disputes over intellectual property, which could hinder development and commercialization efforts [178]. - The rapid technological advancements in the biotech industry pose a risk of obsolescence for the company’s existing and pipeline products if competitors achieve significant breakthroughs [162]. Corporate Governance and Management - The company operates as a red-chip enterprise, listed on both the Hong Kong Stock Exchange and the Shanghai Stock Exchange's Sci-Tech Innovation Board [6]. - The company has a strong management team with experience from major pharmaceutical companies, enhancing its strategic execution capabilities [31]. - The commercialization team has grown to over 300 members, promoting the product Obutin (宜诺凯®) across hundreds of hospitals nationwide [157]. - The company received the national-level "Specialized and Innovative 'Little Giant' Enterprise" recognition in 2023 [142].

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2023年12月31日止年度全年業績公告 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2023年12月31日止年度（「報告期」）之 經審核綜合業績連同截至2022年12月31日止年度之比較數字。本集團於報告期 之綜合財務報表已由董事會及本公司審核委員會審閱並由本公司核數師確認。 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 ...