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]

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].

Group 1 - The core viewpoint of the news is that Nuo Cheng Jian Hua (09969) has shown significant growth in its financial performance, with a notable increase in revenue and a reduction in net loss [1] - For the first half of 2025, the company reported a revenue of 730 million yuan, representing a year-on-year growth of 74.3%, driven by the strong sales of its core product, Obinutuzumab, and an upfront payment from Prolium [1] - The sales of Obinutuzumab reached 637 million yuan, marking a year-on-year increase of 52.8%, while the net loss narrowed to 82 million yuan, a reduction of 67.4% compared to the previous year [1] Group 2 - The company is enhancing its drug discovery platform, focusing on B-cell and T-cell signaling pathways, aiming to develop innovative therapies for autoimmune diseases with unmet medical needs [2] - Nuo Cheng Jian Hua is accelerating multiple Phase III clinical trials in the autoimmune sector, including the combination of Obinutuzumab with ICP-248 for first-line CLL/SLL-FDT treatment, and has completed patient enrollment for these trials [2] - The company aims to create a differentiated autoimmune pipeline and is targeting "first-in-class" or "best-in-class" therapies, which have significant market potential globally [2]

Group 1 - The core viewpoint of the news is that Nuo Cheng Jian Hua (09969) has shown significant growth in its financial performance, with a notable increase in revenue and a reduction in net loss for the first half of 2025 [1][2] - For the first half of 2025, the company reported a revenue of 730 million yuan, representing a year-on-year growth of 74.3%, primarily driven by the strong sales of its core product, Obinutuzumab, and an upfront payment from a licensing agreement with Prolium [1] - The sales of Obinutuzumab reached 637 million yuan, marking a year-on-year increase of 52.8%, while the net loss attributable to shareholders narrowed to 82 million yuan, a reduction of 67.4% compared to the previous year [1] Group 2 - The company is enhancing its drug discovery platform, focusing on B-cell and T-cell signaling pathways, aiming to develop innovative therapies for autoimmune diseases with significant unmet needs [2] - Nuo Cheng Jian Hua is accelerating multiple Phase III clinical trials in the autoimmune sector, including the combination of Obinutuzumab with ICP-248 for first-line CLL/SLL-FDT treatment, and has completed patient enrollment for these trials [2] - The company aims to create a differentiated autoimmune pipeline with the goal of providing "first-in-class" or "best-in-class" therapies, which have broad market potential globally [2]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index increased by 0.39% during the reporting period, ranking 26th among 31 primary industries, underperforming the CSI 300 index which rose by 7.01% [4][14] - The industry shows resilience despite a slight decline in overall revenue and net profit for A-share pharmaceutical companies in the first half of the year, with stable gross profit margins [6] - The CXO sector has returned to high prosperity with significant growth in performance, while the chemical preparation sector shows a mixed performance [6] - The report highlights the approval of several innovative drugs, including Novartis' "Acrux" for IgA nephropathy and the first oral HER2 inhibitor "Zongertinib" by Boehringer Ingelheim [5][41] Industry Review - The pharmaceutical and biotechnology industry PE (TTM, excluding negative values) is at 31.41x, slightly down from 31.38x in the previous period, indicating a valuation below the average [20] - The top three sub-industries by PE are vaccines (56.18x), hospitals (42.24x), and medical devices (40.66x), while pharmaceutical circulation has the lowest valuation at 14.06x [20] - In the reporting period, 29 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 1 billion CNY [4] Important Industry News - The CDE released a draft guideline for single-arm clinical trials to support the regular approval of anti-tumor drugs [25] - Novartis' IgA nephropathy drug "Acrux" received NMPA approval, marking it as the first of its kind in China [28] - The approval of the new generation ALK inhibitor "Dirocitinib" by Xuan Bamboo Biotech for treating ALK-positive non-small cell lung cancer [36] - The approval of the ADC "Datopotamab deruxtecan" for treating HR-positive, HER2-negative breast cancer [39] Investment Recommendations - The report suggests focusing on investment opportunities in the chemical preparation sector, particularly innovative drugs, and the CXO sector due to their clear long-term growth logic [6]

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: 2025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: 2025年9月2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 ...

FF301 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 | 本月底法定/註冊股本總額： USD 50,000 第 1 頁 共 10 頁 v 1.1.1 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: 2025年8月31日 狀態: 新提交 致：香港 ...

在针对NTRK融合基因阳性的晚期实体瘤患者的注册临床试验中，佐来曲替尼展示了卓越的有效性和安 全性，同时可以克服第一代TRK抑制剂的耐药性。 据了解，佐来曲替尼是诺诚健华自主研发的泛TRK抑制剂。佐来曲替尼治疗携带NTRK融合基因的晚期 实体瘤成人和青少年(12周岁≤年龄<18周岁)患者的新药上市申请(NDA)已在中国获受理并纳入优先审 评，佐来曲替尼针对儿童患者(2周岁≤年龄<12周岁)的注册临床试验正在进行中，目标于2025年下半年 提交新药上市申请(NDA)。 诺诚健华联合创始人、董事长兼CEO崔霁松表示："NTRK基因融合在儿童肿瘤中非常常见。佐来曲替 尼纳入'星光计划'是对诺诚健华创新能力的高度认可，我们将加速推进其临床开发，为儿童患者带来更 优治疗方案。" "星光计划"是药审中心为了落实国家药监局"提前介入、一企一策、全程指导、研审联动"的要求，在儿 童药物研发领域开展的一项试点工作，旨在通过申请人填写提交《儿童抗肿瘤药物研发实施框架》的方 式，与药审中心及早进行沟通，获得其抗肿瘤药物在儿童人群研究过程中技术问题的相应指导，并在研 发过程中，与药审中心保持紧密沟通，最终提高儿童抗肿瘤药物的研发效率 ...