Group 1 - China National Medical Products Administration has approved the listing of Zongaitini tablets (brand name: Shenghetu) for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy [1] - Shenghetu is the world's first and currently the only approved oral HER2 tyrosine kinase inhibitor, receiving conditional approval in China based on positive results from the Beamion-LUNG1 study, which evaluated the efficacy and safety of Zongaitini in patients with advanced NSCLC with HER2 (ERBB2) mutations [1] - In the treated cohort of previously treated patients (N=75), the objective response rate (ORR) reached 71% (95% CI: 60-80), with 7% achieving complete response, and the disease control rate (DCR) was as high as 96% [1] Group 2 - Lung cancer remains the leading cancer type globally and in China, with significant unmet clinical needs [2] - The approval of Shenghetu in China will provide a more effective and compliant treatment option for many HER2-mutated non-small cell lung cancer patients, further enriching the company's product line in the oncology field [2] - The company aims to bring therapeutic benefits to more patients with the motto "Health technology, warming more lives" [2]

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，概不對因本公告全部或任何部份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。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 宗艾替尼片獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團與 勃林格殷格翰在中國大陸聯合推廣的宗艾替尼片（商品名：聖赫途® ）已獲得中國國家藥品監督管理局 的上市批准，用於治療存在HER2（ERBB2）激活突變且既往接受過至少一種系統治療的不可切除的局 部晚期或轉移性非小細胞肺癌（NSCLC）成人患者。 1 肺癌無論在全球還是中國，均為第一大癌種，臨床仍存在巨大的未滿足治療需求。聖赫途®在中國獲 批，將為國內眾多HER2突變非小細胞肺癌患者帶來更高效、依從性更佳的治療選擇，也將進一步豐 富本集團在腫瘤領域的產品線，爭取為更多患者帶來治療獲益，用『健康科技，溫暖更多生命』。 [1] Heymach, J. et al. Zongert ...

Core Insights - The approval of Zongertinib (圣赫途) by the National Medical Products Administration of China marks a significant advancement in the treatment of HER2-mutated non-small cell lung cancer (NSCLC) [1][2] - Zongertinib is the first and only oral HER2 tyrosine kinase inhibitor approved globally, providing a new treatment option for patients with advanced NSCLC who have previously received systemic therapy [1] Company Developments - Boehringer Ingelheim and China National Pharmaceutical Group (China Biopharmaceutical) announced their collaboration to promote Zongertinib in mainland China [1] - The drug's conditional approval is based on positive results from the Beamion-LUNG1 study, which demonstrated an objective response rate (ORR) of 71% and a disease control rate (DCR) of 96% among treated patients [1] - The median duration of response (DoR) was reported at 14.1 months, and the median progression-free survival (PFS) was 12.4 months, indicating strong efficacy [1] Industry Impact - The approval of Zongertinib addresses a critical challenge in NSCLC treatment, as there has been a lack of effective oral medications targeting HER2 with good tolerability [2] - The introduction of this innovative drug is expected to set a new benchmark for treating patients with HER2-mutated advanced NSCLC, significantly improving treatment options for a patient group with poor prognosis [2] - The drug's design allows for high selectivity, minimizing severe adverse reactions commonly associated with traditional treatments, thus enhancing patient quality of life [2]

Group 1 - The Hong Kong Innovative Drug ETF (159567) closed down 1.26% on August 28, with a trading volume of 2.227 billion yuan [1] - The fund was established on January 3, 2024, with a management fee of 0.50% per year and a custody fee of 0.10% per year [1] - As of August 27, 2024, the fund's latest share count was 6.506 billion shares, with a total size of 6.134 billion yuan, reflecting a year-to-date increase of 1545.50% in shares and 1523.46% in size compared to December 31, 2023 [1] Group 2 - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 88.56% during the tenure [2] - The top holdings of the fund include Innovent Biologics (9.52%), WuXi Biologics (9.47%), BeiGene (8.73%), and others, with their respective market values and share counts detailed [2] - The fund's liquidity is strong, with a cumulative trading amount of 35.359 billion yuan over the last 20 trading days, averaging 1.768 billion yuan per day [1][2]

Core Insights - China National Pharmaceutical Group's subsidiary, Chengdu Tianqing Pharmaceutical, has successfully completed the first shipment of innovative anti-cancer drugs to the Hong Kong-based Greater China Cancer Foundation, marking a significant step in their collaboration [1][2] - The shipment includes innovative anti-cancer drugs Anlotinib and Bemarituzumab, providing new treatment options for cancer patients in Hong Kong with urgent medical needs [1][2] - The Named Patient Program (NPP) allows doctors to provide unregistered drugs to patients in need, aligning with the Hong Kong government's 2023 policy report aimed at improving drug accessibility [1][2] Company Collaboration - The partnership agreement between Chengdu Tianqing and the Greater China Cancer Foundation was signed in March, focusing on providing innovative cancer treatment solutions to patients with significant unmet medical needs in Hong Kong [2] - The efficient completion of compliance reviews and cross-border logistics demonstrates the effectiveness of the NPP model in enhancing drug accessibility [2] - The president of Chengdu Tianqing emphasized the commitment to advancing China's pharmaceutical development and ensuring that innovative products reach Hong Kong patients [2] Social Responsibility - China National Pharmaceutical Group integrates corporate social responsibility into its development strategy, actively participating in charitable initiatives [3] - The successful shipment enhances treatment options for cancer patients in Hong Kong and reflects the deepening and innovative collaboration between mainland China and Hong Kong in the healthcare sector [3]

Market Performance - The Hang Seng Healthcare Index (HSHCI) decreased by 1.23% as of August 28, 2025, with mixed performance among constituent stocks [3] - The Hang Seng Medical ETF (513060) fell by 1.15%, with a latest price of 0.69 yuan, but showed a 6.26% increase over the past month, ranking in the top third among comparable funds [3] - The Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index (HSSCPB) dropped by 1.02%, with the Hong Kong Innovative Drug Selection ETF (520690) down by 0.81% to 0.98 yuan [4] Company Highlights - Innovent Biologics reported a 50.6% year-on-year revenue increase to 5.95 billion yuan for the first half of 2025, achieving a gross margin of 86% and a net profit of 830 million yuan, driven by pipeline expansion in oncology and new product launches [4] - The company has over 2 billion USD in cash reserves to support future innovation pipeline advancements [4] Policy and Industry Developments - The Ministry of Commerce and Jiangsu Provincial Government issued a plan to enhance the biopharmaceutical industry in Jiangsu Free Trade Zone by 2030, focusing on large molecule biologics, cell and gene therapy, and innovative medical devices [5] - Recent market pressure on the pharmaceutical sector was noted, with the Hang Seng Healthcare Index dropping over 2.1%, influenced by U.S. tariff proposals on imported drugs that could disrupt the global pharmaceutical industry [5] Analyst Insights - Analysts suggest that the recent decline in the Hong Kong pharmaceutical sector is a short-term fluctuation and does not alter the long-term industry outlook, with ongoing favorable policies expected to drive more cross-border business development transactions [6] - The Chinese innovative drug assets are gaining international recognition, presenting structural opportunities in the medium to long term [6] ETF Performance and Metrics - The Hang Seng Medical ETF has seen a significant increase in scale by 46.87 million yuan this month, ranking in the top third among comparable funds [8] - The ETF's share count increased by 92.5 million shares over the past week, also ranking in the top third [9] - The ETF recorded a net inflow of 74.96 million yuan recently, with a total of 65.92 million yuan accumulated over the last five trading days [10] - The ETF's financing net purchase reached 2.5072 million yuan this month, with a financing balance of 268 million yuan [11] Risk and Return Metrics - The Hang Seng Medical ETF has achieved a 48.60% net value increase over the past two years, with a maximum monthly return of 28.34% since inception [11] - The ETF's Sharpe ratio for the past year is 2.41, indicating strong risk-adjusted returns [12] - The ETF has the lowest relative drawdown among comparable funds, with a drawdown of 0.63% year-to-date [13] Valuation Insights - The latest price-to-earnings ratio (PE-TTM) for the Hang Seng Medical ETF is 30.9, which is below the historical average, indicating a potentially undervalued position [15]

Market Overview - The Hong Kong stock market experienced a significant decline in the afternoon, with the Hang Seng Index dropping by 1.27%, losing over 300 points. The Hang Seng China Enterprises Index and the Hang Seng Tech Index fell by 1.4% and 1.47% respectively, with the former barely holding above the 9000-point mark [2] - Major technology stocks, which serve as market indicators, continued to decline in the afternoon. Kuaishou and Meituan fell over 3%, while JD.com dropped by 2.5%. Baidu, NetEase, and Tencent saw declines close to 2%, and Xiaomi fell by 0.56%. Alibaba managed to stay slightly positive [3] Sector Performance - The financial sector, including banks, insurance companies, and Chinese brokerage firms, collectively underperformed, contributing to the overall market decline. The performance of individual stocks continued to be affected by ongoing earnings reports, with property management and real estate stocks experiencing significant drops [3] - Biopharmaceutical stocks faced a collective downturn, particularly in the innovative drug sector, following comments from Trump regarding the rapid imposition of tariffs on pharmaceuticals. This led to notable declines in various biopharma stocks [3] Specific Stock Movements - Several biopharmaceutical companies saw substantial declines, including Kanghao Ya-B (-8.59%), Qiansirui Biotechnology (-7.42%), and Kangfang Biotechnology (-7.10%). Other notable decliners included Xiansheng Pharmaceutical (-6.79%) and Shiyao Group (-6.36%) [3] - In contrast, the rare earth sector remained strong, benefiting from the implementation of supply reforms and multiple catalysts. Apple’s upcoming event on September 9, where the iPhone 17 series is expected to be launched, led to a rise in Apple-related stocks, with Lens Technology (300433) surging nearly 8% and reaching a new high since its listing [4]

Group 1 - The biopharmaceutical sector is currently active, with the Biopharmaceutical ETF (159859) showing a slight increase of 0.23% and a trading volume exceeding 48 million yuan, indicating strong investor interest [1] - The Biopharmaceutical ETF (159859) closely tracks the National Biopharmaceutical Index (399441.SZ), covering various sectors such as innovative drugs, CXO, vaccines, and blood products, making it the largest and most liquid product in its category [1] - The Innovation Drug ETF Tianhong (517380) has seen a slight decline of 0.24% but has recorded a net inflow of over 22.56 million yuan over the past five trading days, reflecting ongoing investor confidence [1] Group 2 - The Chinese government has approved a plan to develop the Jiangsu Free Trade Zone into a globally influential biopharmaceutical industry hub, enhancing its international competitiveness [2] - Major innovative pharmaceutical companies have reported strong performance in their 2025 semi-annual reports, with Heng Rui Pharmaceutical achieving a revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, and a net profit of 4.45 billion yuan, up 29.67% [2] - The domestic innovative drug industry is entering a phase of performance realization after a decade of development, with a focus on the upcoming policy changes and the establishment of a new pricing mechanism for newly launched drugs [3]

Core Viewpoint - The company reported strong financial performance in the first half of 2025, with significant growth in both revenue and net profit, driven by innovative products and a solid position in key therapeutic areas [1][2]. Financial Performance - In H1 2025, the company achieved revenue of 17.57 billion (CNY) (+10.7%) and a net profit attributable to shareholders of 3.39 billion (CNY) (+140.2%) [1]. - Adjusted net profit (non-HKFRS) reached 3.09 billion (CNY) (+101.1%), indicating a substantial increase in profitability [1]. Innovation and Product Development - The company launched two innovative products approved by NMPA in H1 2025, contributing to a revenue of 7.8 billion (CNY) from innovative products (+27.2%), which now account for 44.4% of total revenue (+5.8 percentage points) [1]. - The company has a broad pipeline of nearly 20 innovative products expected to be approved between 2025 and 2027, with over half projected to have peak sales exceeding 2 billion (CNY) [2]. Business Segments - The oncology segment generated revenue of 6.694 billion (CNY) (+24.9%), while the surgical/pain management segment achieved revenue of 3.105 billion (CNY) (+20.2%) in H1 2025 [1]. Future Outlook - The company anticipates that the proportion of revenue from innovative products will increase to 50% in 2025, 55% in 2026, and 60% in 2027, positioning innovation as the core driver of revenue growth [2]. - The acquisition of Lixin Pharmaceutical is expected to enhance the company's innovation pipeline and strengthen its core technology capabilities [2]. Profit Forecast - Revenue projections for 2025-2027 are 32.78 billion (CNY), 36.87 billion (CNY), and 41.14 billion (CNY), with year-on-year growth rates of 13.6%, 12.5%, and 11.6% respectively [3]. - Net profit forecasts for the same period are 4.81 billion (CNY), 4.88 billion (CNY), and 5.12 billion (CNY), with growth rates of 37.5%, 1.5%, and 4.8% respectively [3].

Core Insights - China Biopharmaceutical reported strong financial growth for H1 2025, with revenue of 17.57 billion yuan, a year-on-year increase of 10.7%, and a net profit of 3.39 billion yuan, up 140.2% [1] - The company has a robust pipeline in key therapeutic areas, including oncology, liver disease/metabolism, respiratory, and surgical/pain management, with several products in advanced clinical stages [2][3] Financial Performance - Revenue for H1 2025 reached 17.57 billion yuan, reflecting a 10.7% increase year-on-year [1] - Net profit from continuing operations was 3.39 billion yuan, showing a significant growth of 140.2% year-on-year [1] - Adjusted net profit was approximately 3.09 billion yuan, up 101.1% year-on-year [1] - Basic earnings per share (EPS) were 0.188 yuan, an increase of 145.7% year-on-year [1] - Cash reserves stood at 30.49 billion yuan, with 11.1 billion yuan in cash on hand [1] Innovation and Product Development - Revenue from innovative products reached 7.8 billion yuan, a year-on-year increase of 27.2%, accounting for 44.4% of total revenue [1] - The company has 18 innovative products, with expectations to exceed 35 by 2027 [1] - Recent approvals include the domestic recombinant human coagulation factor VIIa product and the long-acting analgesic NSAID injection [1] Pipeline Advancements - Key pipelines in oncology include TQB2922 and TQB6411 for lung cancer, and TQB3616 and TQB2102 for breast cancer, with multiple indications being pursued [2] - In gastrointestinal tumors, LM-108 has received breakthrough therapy designation, while TQB2868 is leading globally in development [2] - The respiratory/infection area features TQC3721, which is in the second position globally in development [2] - In liver disease/metabolism, Lanifibranor has completed patient enrollment for its Phase III trial, with expectations for a 2026 market application [2] Strategic Acquisitions - The company acquired Lixin Pharmaceutical for a net consideration of 500 million USD, enhancing its technology platform for antibody discovery and ADC development [3] - This acquisition is expected to accelerate the translation of Lixin's innovative pipeline, including several promising candidates [3] Profit Forecast - The company forecasts net profits of 3.454 billion yuan, 3.979 billion yuan, and 4.570 billion yuan for 2025-2027, with corresponding EPS of 0.18 yuan, 0.21 yuan, and 0.24 yuan [4]