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]

Core Insights - The pharmaceutical and biotechnology sectors are experiencing fluctuations, with the innovative drug index showing a slight increase of 0.65% while the Hang Seng Healthcare Index decreased by 3.36%, marking the largest weekly decline for Hong Kong's innovative drugs in nearly two months [5][6]. Company Developments - Fukan Biotech submitted its listing application to the Hong Kong Stock Exchange, achieving a post-financing valuation of 3.188 billion yuan after its C2 round of financing. The company focuses on breakthrough therapies for cancer-related diseases and has a diverse product pipeline, including one commercialized product and several candidates in development [7]. - Tianxing Medical also submitted its application to the Hong Kong Stock Exchange, positioning itself as China's largest domestic sports medicine company. The company reported revenues of 327 million yuan and 111 million yuan for 2024 and the first five months of 2025, respectively, with corresponding pre-tax profits of 108 million yuan and 36.83 million yuan [9]. Clinical Trials and Approvals - The National Medical Products Administration disclosed 80 clinical trial registrations from August 24 to August 29, with 24 trials in Phase II or above [10]. - The first oral HER2 inhibitor, Zongertinib, developed by Boehringer Ingelheim, received conditional approval in China for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [14]. - Pfizer initiated the first Phase III clinical trial for its PD-L1 ADC drug, PF-08046054, targeting previously treated PD-L1 positive NSCLC patients, with a total enrollment of 680 participants [18]. Market Trends - The STEER real-world study presented at the European Society of Cardiology Congress indicated that Wegovy (semaglutide) significantly reduced the risk of major adverse cardiovascular events by 57% compared to Tirzepatide in overweight or obese patients with cardiovascular disease [16].

Market Overview - The Hang Seng Index rose by 0.3% last week, closing at 25,339 points, while the Hang Seng Tech Index increased by 1.9% to 5,647 points[1] - Average daily trading volume increased by 3.6% to HKD 280.4 billion, with a net inflow of HKD 17.8 billion through the Stock Connect[1] - The real estate, utilities, energy, and materials sectors saw declines between 0.6% and 2.2%, while consumer discretionary and information technology sectors rose by 1.6%[1] Economic Dynamics - The US manufacturing PMI rose to 53.3, indicating expansion, while the services PMI slightly decreased to 55.4, remaining at a high level[2] - Price pressures persist, with the purchasing price index soaring to 67.1, indicating ongoing inflation risks[2] Industry Insights - Xpeng Motors reported better-than-expected earnings, leading to a 13.1% increase in its stock price last Friday[3] - The healthcare sector saw a 0.9% increase in the Hang Seng Healthcare Index, with notable performances from companies like China Biologic Products and WuXi Biologics[4] Company Performance - Yancoal Australia reported a 61.2% drop in net profit for H1 FY25, with revenue down 14.8% to AUD 268 million[6] - The company expects a rebound in coal prices in H2 FY25, with average prices projected to decline by 7.1% for thermal coal and 20.7% for metallurgical coal[7] Forecast Adjustments - Target price for Yancoal Australia adjusted from HKD 38.55 to HKD 34.70, reflecting a 22.9% upside potential[9] - HanSung Pharmaceutical's revenue for H1 2025 increased by 14.3% to RMB 7.43 billion, with net profit rising by 15.0% to RMB 3.14 billion[12]

Group 1 - The core viewpoint of the article highlights that China National Pharmaceutical Group (中生制药) has seen a significant stock price increase, attributed to the recognition of its selective HER2 tyrosine kinase inhibitor, Zongaitini, as a breakthrough therapy by the National Medical Products Administration (NMPA) in China for treating adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) [1] - The stock price rose over 6%, with a current price of 8.14 HKD and a trading volume of 1.077 billion HKD [1] - Citigroup's report indicates that China National Pharmaceutical Group's net profit for the first half of the year reached 3.4 billion RMB, a year-on-year increase of 140%, while revenue was 17.6 billion RMB, reflecting a 10.2% growth compared to the previous year [1] Group 2 - The company's profit and revenue figures exceeded market consensus and Citigroup's expectations [1] - Management expresses strong confidence in the potential for licensing innovative candidate drugs, including TQC3721 (PDE3/4) [1] - CICC anticipates that the approval progress for the company's innovative products will accelerate over the next three years, potentially driving additional revenue [1]

Group 1 - The core viewpoint of the article highlights the significant stock price increase of China National Pharmaceutical Group (中生制药), which rose over 6% and is currently trading at 8.14 HKD with a transaction volume of 10.77 billion HKD [1] - The company has received breakthrough therapy designation from the China National Medical Products Administration (CDE) for its selective HER2 tyrosine kinase inhibitor, Zongaitini, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 TKD activating mutations [1] - Citigroup reported that China National Pharmaceutical Group's net profit for the first half of the year reached 3.4 billion RMB, a year-on-year increase of 140%, while revenue was 17.6 billion RMB, up 10.2% year-on-year, exceeding market consensus and Citigroup's expectations [1] Group 2 - The management of China National Pharmaceutical Group is optimistic about the licensing potential of its innovative drug candidates, including TQC3721 (PDE3/4) [1] - CICC anticipates that the approval progress of the company's innovative products will accelerate over the next three years, potentially driving more revenue for the company [1]

Group 1 - China National Pharmaceutical Group announced that the selective HER2 tyrosine kinase inhibitor "Zongaitini" has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 tyrosine kinase domain (TKD) activating mutations [1] - The breakthrough therapy designation is based on data from the Beamion LUNG-1 clinical trial, which is a Phase Ia/Ib open-label trial assessing the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of Zongaitini in patients with HER2-mutant solid tumors [1] - The five-year survival rate for advanced non-small cell lung cancer patients is less than 30%, with approximately 2-4% of NSCLC driven by HER2 gene mutations, indicating a significant unmet medical need for targeted therapies in this patient population [1] Group 2 - Zongaitini is a covalent, orally administered selective HER2 small molecule inhibitor developed by Boehringer Ingelheim, which covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring efficacy along with good tolerability and safety [2] - Zongaitini has previously received priority review and breakthrough therapy designation from CDE for the indication of previously treated patients with advanced HER2-mutant NSCLC, and it received accelerated approval from the U.S. Food and Drug Administration (FDA) in August [2]

Group 1 - China National Medical Products Administration (NMPA) has granted breakthrough therapy designation to the selective HER2 tyrosine kinase inhibitor, Zongaitini, for first-line treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD) activating mutations [1] - The breakthrough designation is based on data from the Beamion LUNG-1 clinical trial, which is an open-label Phase Ia/Ib trial assessing the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of Zongaitini in patients with HER2-mutant solid tumors [1] - The five-year survival rate for advanced NSCLC patients is less than 30%, with approximately 2-4% of NSCLC driven by HER2 gene mutations, indicating a significant unmet medical need for targeted therapies in this patient population [1] Group 2 - Zongaitini, developed by Boehringer Ingelheim, is a covalent, oral selective HER2 small molecule inhibitor that covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring efficacy along with good tolerability and safety [2] - Zongaitini has previously received priority review and breakthrough therapy designation from the NMPA for the indication of previously treated patients with advanced HER2-mutant NSCLC, and it has also received accelerated approval from the U.S. Food and Drug Administration (FDA) [2] - Boehringer Ingelheim has established a strategic partnership with the group to bring innovative oncology therapies to the mainland China market, leveraging both parties' complementary strengths to provide better treatment options for cancer patients [2]

（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 選擇性HER2 TKI「宗艾替尼」再次獲得CDE突破性治療資格認定 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，選擇性 HER2酪氨酸激酶抑制劑(TKI)「宗艾替尼」再次獲得中國國家藥品監督管理局藥品審評中心(CDE)突破 性治療資格認定，用於治療攜帶HER2酪氨酸激酶結構域(TKD)激活突變的不可切除或轉移性非小細 胞肺癌(NSCLC)成人患者的一線治療。 此次突破性治療資格認定是基於其Beamion LUNG-1臨床試驗數據。這是一項Ia/Ib期首次人體開放 標籤試驗，以確定宗艾替尼在HER2突變實體瘤患者中的安全性、最大耐受劑量(MTD)、藥代動力學 (PK)、藥效學(PD)及初步療效(NCT04886804)。最新數據將於今年晚些時候公布。 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 ...