智通财经APP讯，中国同辐(01763)发布公告，本公司附属公司原子高科股份有限公司(原子高科)与诺华 医药科技(浙江)有限公司(诺华公司)正式签署派威妥®(镥[177Lu]特昔维匹肽注射液)商业合作协议(商业 合作协议)。派威妥® 是国内首个且目前唯一获批的靶向PSMA的放射配体疗法药物，主要用于治疗晚 期前列腺癌，未来将为患者提供延长生命并改善生活质量的全新核药治疗方案。此次签约开启了双方在 创新核药产品派威妥®方面的战略合作，原子高科将凭藉在放射性药物领域的多年合规运营经验，与诺 华公司强强联合，为医疗机构和患者提供定制化的派威妥®产品供应与解决方案，以惠及更多的患者。 ...

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The report emphasizes three core investment directions: 1) Breakthroughs in cutting-edge technologies (e.g., First-in-class drugs in oncology, weight loss, autoimmune fields, and innovative devices like brain-machine interfaces); 2) Clinical validation and commercialization potential (focus on the progress of domestic innovative drugs going abroad and the clinical development progress post-BD transactions); 3) Efficiency advantages in the industry chain (CXO leaders and high-value consumables' global layout) [8] Industry Review - The pharmaceutical and biotechnology industry index increased by 0.81%, ranking 21st among 31 primary industries, outperforming the CSI 300 index which decreased by 0.27% [5][16] - The sub-industries of pharmaceutical circulation and in vitro diagnostics saw significant gains of 7.61% and 5.32% respectively, while medical research outsourcing and medical devices experienced declines of 3.49% and 1.76% [5][16] - As of November 14, 2025, the industry PE (TTM overall method, excluding negative values) was 30.89x, up from 30.67x in the previous period, indicating an upward valuation trend that remains below the average [21] - The top three PE ratios among the sub-industries were for vaccines (50.42x), hospitals (43.67x), and medical devices (37.84x), while pharmaceutical circulation had the lowest valuation at 15.46x [21] Important Industry News - The National Health Commission and others issued implementation opinions to promote and regulate the application of "AI + healthcare" [7] - The NMPA released a new version of the "Medical Device Production Quality Management Specifications" [7] - Novartis received NMPA approval for its first radioligand therapy drug "Pluvicto®" for dual indications [7] - Sanofi's innovative targeted nano-antibody "Cablivi®" was approved by NMPA for treating immune-mediated thrombotic thrombocytopenic purpura [7] - The U.S. government reached a drug price control agreement with Eli Lilly and Novo Nordisk, leading to significant price reductions for GLP-1 drugs [7]

Core Insights - Novartis announced the approval of its radioligand therapy (RLT) drug, Pluvicto® (Lutetium [177Lu] vipivotide tetraxetan injection), for two indications in China, targeting metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed after androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy [1][2] - This approval marks Pluvicto® as the first and only targeted PSMA radioligand therapy approved in China, providing new treatment options for advanced prostate cancer patients with limited choices [1] - The approvals are based on results from global Phase III VISION and PSMAfore studies, along with corresponding bridging studies conducted in China [1] Group 1 - Novartis is actively exploring the use of Lutetium [177Lu] vipivotide tetraxetan injection for earlier lines of prostate cancer treatment [2] - The Phase III PSMAddtion study in metastatic hormone-sensitive prostate cancer (mHSPC) has shown a significant 28% reduction in the risk of radiographic progression or death (HR 0.72, p=0.002) [2] - Based on these results, Novartis has submitted a new drug application to Chinese regulatory authorities for this indication, aiming to benefit a broader range of prostate cancer patients in China [2]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1]. Core Views - The report highlights a positive change in the specialty raw materials sector, recommending companies such as Aorite and Prolo Pharmaceuticals [1]. - The report suggests that the Q3 performance of raw material pharmaceutical companies has reached a bottom, indicating potential recovery in profitability as high-cost inventory is consumed [19][20]. Summary by Sections Investment Highlights - The recommended sub-industry rankings are: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12]. - Specific stock recommendations include: - From raw materials: Aorite, Qianhong Pharmaceutical - From Traditional Chinese Medicine: Zorui Pharmaceutical, Fangsheng Pharmaceutical, Dong'e Ejiao - From medical devices: United Imaging Healthcare, Yuyue Medical - From AI pharmaceuticals: Jingtai Holdings - From GLP-1 sector: Lianbang Pharmaceutical, Borui Pharmaceutical, Zhongsheng Pharmaceutical, and Innovent Biologics - From PD-1/VEGF dual antibodies: Sanofi Biopharmaceuticals, Kangfang Biologics, and Rongchang Biopharmaceuticals - From innovative drugs: Innovent Biologics, BeiGene, HengRui Medicine, Zai Lab, Baillie Tianheng, Kelun Pharmaceutical, Dize Pharmaceutical, and Haizheng Pharmaceutical [3][15]. Industry Trends - The A-share pharmaceutical index has seen a year-to-date increase of 18.2%, while the Hang Seng Biotechnology Index has increased by 76.6% [6][11]. - The report notes that the raw material pharmaceutical sector is under pressure due to high base effects and declining prices, with significant revenue impacts [19][20]. R&D Progress and Company Dynamics - Recent approvals include Novartis' radioligand therapy drug, which received dual indications for prostate cancer treatment [2]. - The report provides an overview of ongoing clinical trials and drug approvals, emphasizing the importance of innovation in the pharmaceutical sector [30]. Market Performance - The report indicates that the pharmaceutical sector has experienced adjustments, with notable stock performances including significant gains for companies like Hezhong China (+61%) and Wanze Shares (+30%) [11]. - The report also highlights the performance of various pharmaceutical stocks, noting both gains and losses in the market [16][17]. Raw Material Pricing Trends - The price of 6-APA has dropped significantly, from 370 RMB/kg in 2022 to 180 RMB/kg in October 2025, a decrease of 51% [23]. - The price of Amoxicillin has also decreased from 320 RMB/kg in January 2023 to 190 RMB/kg in October 2025, a decline of 41% [23]. Conclusion - The report suggests that as high-cost inventory is depleted, the gross margins for raw material producers are expected to improve, indicating a potential recovery in profitability for companies like Fuxiang Pharmaceutical and Lukang Pharmaceutical [19][23].

Core Viewpoint - Novartis Pharmaceuticals (NVS.US) announced that its radioligand therapy (RLT) drug, Pluvicto® (lutetium [177Lu] vipivotide tetraxetan injection), received approval from the National Medical Products Administration for two indications related to metastatic castration-resistant prostate cancer (mCRPC) in adult patients [1] Group 1: Drug Approval Details - Pluvicto® is the first and currently the only targeted PSMA radioligand therapy drug approved in China [1] - The two approved indications are for adult patients with PSMA-positive mCRPC who have previously progressed after androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy, and for those who have progressed after ARPI and taxane chemotherapy [1] - Both indications had previously received priority review designation, indicating their significance in addressing unmet medical needs [1] Group 2: Market Implications - The approval is expected to provide a new treatment option for Chinese patients with advanced prostate cancer who have limited treatment choices, potentially extending survival and improving quality of life [1]