今年4月，宜诺凯®在中国获批用于一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 (CLL/SLL) 。此 前，宜诺凯®已在中国获批用于治疗既往至少接受过一次治疗的CLL/SLL、套细胞淋巴瘤（R/R MCL） 和边缘区淋巴瘤（R/R MZL），三项适应症均已纳入中国国家医保。 2025年9月8日，中国北京——生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码： 09969）今天宣布，宜诺凯®（奥布替尼）已获得新加坡卫生科学局（HSA）的批准，用于治疗复发/难 治性边缘区淋巴瘤（R/R MZL）成人患者。这是宜诺凯®在新加坡获批的第二项适应症，标志着公司在 国际化道路上又迈出了坚实的一步。 （文章来源：证券时报网） 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："非常高兴奥布替尼在新加坡又获批新适应症。奥 布替尼作为高选择性BTK抑制剂，在治疗复发/难治性边缘区淋巴瘤中显示了良好的有效性和安全性， 相信奥布替尼会为新加坡当地淋巴瘤患者带来新的治疗选择。除了淋巴瘤，我们也正在全速推进奥布替 尼在自身免疫疾病领域的全球化进程。" 奥布替尼是诺诚健华自主研发的具有高度靶标选择性的新型BTK抑制剂，可 ...

2025年9月8日，中国北京——生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码： 09969）今天宣布，宜诺凯 （奥布替尼）已获得新加坡卫生科学局（HSA）的批准，用于治疗复发/难 治性边缘区淋巴瘤（R/R MZL）成人患者。这是宜诺凯 在新加坡获批的第二项适应症，标志着公司在 国际化道路上又迈出了坚实的一步。 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："非常高兴奥布替尼在新加坡又获批新适应症。奥 布替尼作为高选择性BTK抑制剂，在治疗复发/难治性边缘区淋巴瘤中显示了良好的有效性和安全性， 相信奥布替尼会为新加坡当地淋巴瘤患者带来新的治疗选择。除了淋巴瘤，我们也正在全速推进奥布替 尼在自身免疫疾病领域的全球化进程。" 奥布替尼是诺诚健华自主研发的具有高度靶标选择性的新型BTK抑制剂，可以避免脱靶相关的不良事 件，改善安全性和有效性，旨在开发治疗血液肿瘤及自身免疫性疾病。 边缘区淋巴瘤（MZL）是一类惰性B细胞非霍奇金淋巴瘤（NHL），主要影响中老年人群，年发病率在 全球范围内呈上升趋势。经过一线治疗后，疾病进展/复发的MZL患者仍缺乏有效的治疗手段。 今年4月，宜诺凯 在中国获批用 ...

Company Overview - InnoCare Pharma is a leading biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs globally [5] Product Approval - HIBRUKA (orelabrutinib) has received approval from the Health Sciences Authority (HSA) of Singapore for treating adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL) [1][2] - This marks the second indication approval for orelabrutinib in Singapore, following its previous approval for other indications [2] Product Efficacy and Safety - Orelabrutinib is a highly selective BTK inhibitor that has shown good efficacy and safety in treating R/R MZL, providing a new treatment option for local lymphoma patients [2] - The drug's high target selectivity minimizes off-target effects, enhancing both safety and efficacy [2] Market Context - Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma primarily affecting middle-aged and elderly patients, with an increasing annual incidence globally [3] - Patients with R/R MZL often lack effective treatment options after first-line therapy [3] Previous Approvals - In April 2025, orelabrutinib was approved in China for the first-line treatment of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) and has received approvals for three other indications, including R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, all included in China's National Reimbursement Drug List [4]

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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告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） 海外監管公告 本公告乃諾誠健華醫藥有限公司（「本公司」）根據香港聯合交易所有限公司證 券上市規則第13.10B條作出。 茲載列本公司於上海證券交易所網站刊登之《中國國際金融股份有限公司關於 諾誠健華醫藥有限公司2025年半年度持續督導跟蹤報告》。 承董事會命 諾誠健華醫藥有限公司 主席兼執行董事 崔霽松博士 香港，二零二五年九月五日 於本公告日期，董事會包括主席兼執行董事崔霽松博士；執行董事趙仁濱博士；非執行董事 施一公博士及謝榕剛先生；以及獨立非執行董事胡蘭女士、董丹丹博士及管坤良教授。 中国国际金融股份有限公司 关于诺诚健华医药有限公司 2025 年半年度持续督导跟踪报告 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 ...

Group 1 - The company is engaged in the research, development, production, and commercialization of innovative biopharmaceuticals, with a focus on oncology and autoimmune diseases [5][6][12] - The company has received conditional approval for its main product, Acalabrutinib (Ibrutinib), which is used for treating various types of blood cancers [5][9] - The company has not yet achieved profitability and is facing cumulative losses, with significant ongoing research and development expenses [5][23] Group 2 - In the first half of 2025, the company reported revenue of 731 million yuan, a year-on-year increase of 74.26%, but still incurred a net loss of 30 million yuan [5][6] - The company is required to complete confirmatory clinical trials for Acalabrutinib to obtain full approval, which introduces uncertainty regarding its market potential [9][10] - The company faces intense competition in the market, with existing products and ongoing clinical trials from other companies [12][22] Group 3 - The company has established a production facility in Guangzhou that meets GMP standards, but faces risks related to supply chain disruptions and regulatory compliance [17][18] - The company is subject to strict regulatory oversight, which may impact its ability to market and sell its products effectively [16][28] - The company is actively seeking strategic partnerships to enhance its research and commercialization efforts, but faces challenges in establishing these relationships [19][24]

中国国际金融股份有限公司 关于诺诚健华医药有限公司 2025 年半年度持续督导跟踪报告 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》（以下简称"《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》等相关规定，中国国际金融股份有限公司（以下简称"中金公司" 或"保荐机构"）作为诺诚健华医药有限公司（以下简称"诺诚健华"、"公司"）首 次公开发行股票并在科创板上市以及持续督导工作的保荐机构，负责诺诚健华上市 后的持续督导工作，并出具 2025 年半年度持续督导跟踪报告，本持续督导期间为 2025 年 1 月 1 日至 2025 年 6 月 30 日。 | 一、持续督导工作情况 | | --- | | 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前， 与上市公司或 ...

Core Viewpoint - Nocera Health experienced a stock price decline of 2.02% on September 5, 2023, with a current price of 27.15 CNY per share, despite a year-to-date increase of 121.09% [1] Company Overview - Nocera Health, established on November 3, 2015, and listed on September 21, 2022, is based in Beijing and focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [1] - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and R&D services [1] Financial Performance - For the first half of 2025, Nocera Health reported a revenue of 731 million CNY, reflecting a year-on-year growth of 74.26%, while the net profit attributable to shareholders was -30.09 million CNY, an increase of 88.51% year-on-year [2] Shareholder Information - As of June 30, 2025, the number of shareholders increased by 13.80% to 15,200, with an average of 0 circulating shares per shareholder [2] - The top ten circulating shareholders include notable funds such as China Europe Medical Health Mixed A and E Fund Precision Medical Flexible Allocation Mixed A, with changes in their holdings noted [3]

Group 1 - The core viewpoint of the news is that Nocera Biopharma experienced a decline in stock price, dropping by 5.04% to 28.08 CNY per share, with a trading volume of 1.67 billion CNY and a turnover rate of 2.14%, resulting in a total market capitalization of 495.51 billion CNY [1] - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [1] - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and research services [1] Group 2 - From the perspective of major fund holdings, a fund under Yinhua Asset Management holds a significant position in Nocera Biopharma, with 267,100 shares representing 5.11% of the fund's net value, ranking as the seventh-largest holding [2] - The Yinhua CSI All-Share Healthcare Index Enhanced Fund (005112) has a total scale of 1.28 billion CNY and has achieved a year-to-date return of 31.97%, ranking 1002 out of 4222 in its category [2] - The fund has a one-year return of 47.33%, ranking 1796 out of 3789, and a cumulative return since inception of 57.47% [2]

Group 1: Hong Kong Stocks - Photovoltaic stocks rose in the morning, with Xinyi Solar (00968) up over 3%, Fuyao Glass (03606) up over 3%, and GCL-Poly Energy (00451) up over 3%. Domestic leading polysilicon companies have raised prices, and the market is focused on the restructuring progress in the polysilicon industry [1] - Heng Rui Medicine (01276) increased by over 5% after announcing the approval of HRS-7172 tablets for clinical trials by the National Medical Products Administration on September 2 [1] - Qingdao Bank (03866) rose over 2% as its major shareholder plans to increase holdings by 233 million to 291 million shares, recognizing the long-term investment value of the bank's stock [1] - Zhaojin Mining (01818) increased by over 1%, with a total market value exceeding HKD 100 billion, and the company is accelerating overseas project construction, indicating future growth potential [1] - Zhongsheng Holdings (00881) rose over 4%, with management optimistic about the new car market and smooth progress in the company's new energy business [1] - Innovent Biologics (09969) increased by over 5% after disclosing its interim performance report, with core products driving growth and accelerating multiple self-immune phase III clinical trials [1] - United Laboratories (03933) rose over 6% after announcing a 27% year-on-year increase in profit attributable to shareholders in its half-year results, with key progress in several products in the formulation segment [1] Group 2: U.S. Stocks - NIO (NIO.US) rose 3.13%, with vehicle deliveries in August 2025 reaching 31,305 units, a year-on-year increase of 55.2%, and total deliveries since 2025 reaching 166,472 units, up 30.0% [3] - Hesai Technology (HSAI.US) fell 2.91% as it plans to list in Hong Kong after passing the hearing [3] - Eli Lilly (LLY.US) rose 0.36% after Novo Nordisk's weight loss drug Wegovy outperformed it in a real-world comparative study [3] - Zai Lab (ZLAB.US) increased by 0.73% after announcing that its drug was approved in Hong Kong for treating recurrent or metastatic cervical cancer [3] - Beike (BEKE.US) rose 4.89% after reporting a 11.3% year-on-year increase in net income for the second quarter, leading multiple institutions to reaffirm a "buy" rating [3] - Gold stocks rose against the trend, with Gold Resource (GORO.US) up 15.80%, Harmony Gold (HMY.US) up 7.53%, and Kinross Gold (KGC.US) up 2.68%, driven by expectations of U.S. interest rate cuts and a weak dollar [3] - Corning (GLW.US) rose 2.15% after UBS raised its target price from $65 to $84 and upgraded its rating from "neutral" to "buy" [4] - Li Auto (LI.US) rose 4.50% as the founder announced plans to fully enter the high-end pure electric SUV market [4]

Core Viewpoint - Nocera Biopharma reported a significant revenue increase of 74.26% year-on-year, reaching 730 million yuan in the first half of 2025, with a reduction in losses to 36 million yuan, a decrease of 86.7% compared to the previous year. The core product, Oubatinib, generated sales of 637 million yuan, marking a 52.48% increase year-on-year [1][10]. Financial Performance - The company achieved total revenue of 730 million yuan in H1 2025, a 74.26% increase, primarily driven by the sales of Oubatinib and an upfront payment from a licensing agreement with Prolium. Drug sales reached 640 million yuan, up 53.47%, with Oubatinib sales contributing 637 million yuan, reflecting a 52.48% growth [1][10]. - R&D expenses for H1 2025 were 450 million yuan, a 6.9% increase, while sales expenses rose by 55.31% to 240 million yuan due to intensified commercialization efforts. Management expenses decreased by 1.61% to 83 million yuan [11]. Product Development and Pipeline - Oubatinib's sales growth is attributed to its approval for first-line treatment of CLL/SLL and its potential in autoimmune diseases. The company is advancing multiple Phase III clinical trials, including for ITP and multiple sclerosis [5][6]. - The company is also focusing on expanding its pipeline in hematological malignancies with products like Tafasitamab and Mesutoclax, which are showing promising clinical results [2][3][4]. Market Position and Strategy - Nocera Biopharma is strengthening its leadership in the hematological oncology field through its three main products: Oubatinib, Tafasitamab, and Mesutoclax. The company aims to enhance its competitive edge in this area [2]. - The company is actively pursuing new indications for Oubatinib in autoimmune diseases, with ongoing Phase III trials for conditions like primary progressive multiple sclerosis and immune thrombocytopenic purpura [5][6]. Future Outlook - The company anticipates continued revenue growth, projecting a 35% increase in Oubatinib sales for the full year 2025. The establishment of a commercialization team is expected to enhance market penetration [12]. - Revenue forecasts for 2025, 2026, and 2027 are estimated at 1.444 billion yuan, 1.889 billion yuan, and 2.414 billion yuan, respectively, with corresponding growth rates of 43%, 30.87%, and 27.81% [12].