Group 1: Cobalt Export Quota in Congo - The Democratic Republic of Congo (DRC) has announced a cobalt export quota, effective from October 16, aimed at strengthening resource sovereignty and signaling a shift from a surplus to a shortage in the cobalt market, leading to a systematic increase in price levels [1] - The DRC's Strategic Mineral Market Regulatory Authority stated that miners will be allowed to export slightly over 18,000 tons of cobalt for the remainder of this year, with annual export limits of 96,600 tons for 2026 and 2027, which is less than half of last year's production [1] - The quota distribution includes major companies such as Luoyang Molybdenum, which received a quota of 31,200 tons (32.3%), exceeding some prior expectations [1] Group 2: Future Cobalt Supply and Demand - Institutions predict a cobalt supply gap in the next two years, with global supply expected to be 290,000 tons in 2024 (DRC 220,000 tons + Indonesia 28,000 tons) against a demand of 185,000 tons, resulting in a surplus of 105,000 tons; by 2026, supply is projected to drop to 180,000 tons (DRC 96,600 tons + Indonesia 40,000 tons) while demand will rise to 200,000 tons, leading to a shortfall of 20,000 tons [2] Group 3: Market Trends and Stock Performance - The Nasdaq China Golden Dragon Index fell by 6.1%, with major U.S. stock indices also experiencing significant declines, indicating a bearish trend in the market [3] - Notable declines were observed in large tech stocks, with companies like Broadcom and Tesla dropping nearly 6% and 5.06% respectively, reflecting broader market challenges [3] Group 4: Rare Earth Prices - Baotou Steel and Northern Rare Earth announced an increase in rare earth concentrate prices for Q4 2025, with a projected 37.13% increase compared to Q3 [7] Group 5: Company Announcements - China Energy Construction signed three new energy EPC contracts worth approximately 27.45 billion USD (about 195.54 billion RMB) with Saudi companies [11] - Smoore International reported a record high quarterly revenue of approximately 4.1968 billion RMB, a year-on-year increase of about 27.2% [12] - Kelun-Biotech's TROP2ADC drug received approval for a new indication, expanding its market potential in treating specific lung cancer cases [13] - Zhaojin Mining reported a net profit of approximately 2.117 billion RMB for the first three quarters of 2025, a year-on-year increase of 140.43% [14]

Major Events - Yuan Da Zhu Gong (02163) plans to apply for bankruptcy reorganization at Changsha Intermediate People's Court [1] - Yi Li Holdings (00076) subsidiary intends to issue blockchain vouchers V76, redeemable for bulk commodities on the platform [1] - Peijia Medical-B (09996): National Medical Products Administration accepts registration application for GeminiOne® transcatheter edge-to-edge repair system [1] - Paggen Biopharmaceutical-B (02565) proposes to grant exclusive license for VISEPEGENATIDE (PB-119) in the Middle East and Africa [1] - Beijing Enterprises Environment Group (00154) bids for Hong Kong I·PARK 2 project [1] - Fangda Holdings (01521) plans to acquire Shanghai Guanhua Medical Technology Co., Ltd. for 270 million yuan to enhance global laboratory service capabilities [1] - Lianzhong (06899) focuses on female user value, driving new entertainment through content [1] - Global New Materials International (06616) increases stake in CQV to 50.75%, strengthening global business collaboration [1] - Qianxin Biotechnology-B (02509): Qianxin's industrialization base successfully passes EU QP audit [1] - China Energy Construction (03996) subsidiary signs three new energy general contracting agreements, totaling approximately 19.554 billion yuan [1] - Yongyi International (01218) plans to sell all issued shares of Zhuoyi to Gaoshan (00616) [1] - Bohai Bank (09668) plans to list high capital-occupying debt assets for sale, with an initial pricing of no less than 48.883 billion yuan [1] - Chuangsheng Holdings (02680) plans to receive a premium of about 6% for full acquisition offer, resuming trading on October 13 [1] - Kelun-Botai Biopharmaceutical (06990): Core product TROP2ADC, Lukan-Satuzi (SAC-TMT) approved by National Medical Products Administration for third indication, treating EGFR mutation non-small cell lung cancer after EGFR-TKI progression [1] Operating Performance - Zhaojin Mining (01818) reports net profit of approximately 2.117 billion yuan for the first three quarters, a year-on-year increase of 140.43% [2] - Sunny Optical Technology (02382): September mobile phone camera module shipments reach 48.524 million units, a month-on-month increase of 15.3% and a year-on-year increase of 32% [2] - Yuexiu Property (00123) reports cumulative contract sales of approximately 79.812 billion yuan for the first nine months, a year-on-year increase of about 2.8% [2] - Qiu Tai Technology (01478) reports September camera module sales of 46.654 million units, a month-on-month decrease of 7.6% but a year-on-year increase of 45.1% [2]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) sac-TMT for a third indication marks a significant advancement in the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1: Product Approval and Clinical Significance - The National Medical Products Administration (NMPA) has approved sac-TMT for treating adult patients with locally advanced or metastatic NSCLC who have progressed after TKI treatment [1] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1] - The treatment has demonstrated statistically and clinically significant improvements in progression-free survival (PFS) and OS compared to standard platinum-based chemotherapy [1] Group 2: Clinical Research and Future Developments - The approval is based on the results of a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed plus platinum-based therapy in patients with EGFR mutation-positive NSCLC who have failed EGFR-TKI treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC has completed patient enrollment in China [2]

Core Viewpoint - The approval of sac-TMT (also known as SKB264/MK-2870) for a third indication by the National Medical Products Administration (NMPA) represents a significant advancement in the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1: Drug Approval and Indications - The NMPA has approved sac-TMT for treating adult patients with locally advanced or metastatic non-squamous NSCLC who have progressed after TKI treatment [1] - Sac-TMT is the first and only antibody-drug conjugate (ADC) to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy [1][2] - The approval is based on the results of the OptiTROP-Lung04 study, which evaluated the efficacy and safety of sac-TMT compared to pemetrexed plus platinum-based therapy [2] Group 2: Clinical Study and Results - The OptiTROP-Lung04 study is a randomized, open-label, multicenter Phase III clinical trial that will present its findings at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study aims to assess the effectiveness of sac-TMT administered every two weeks at a dose of 5 mg/kg via intravenous injection against standard treatment in patients with EGFR mutation-positive NSCLC who have failed EGFR-TKI therapy [2] - Sac-TMT has shown statistically and clinically significant improvements in progression-free survival and overall survival compared to standard platinum-based chemotherapy [1][2]

Core Insights - The company Keren Biotechnology (06990.HK) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for a third indication in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - The approval is based on a randomized, open-label, multi-center Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to standard platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for use in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI and platinum-based chemotherapy [2] - The single-agent therapy with sac-TMT significantly extends the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [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2025年3月，蘆 康 沙 妥 珠 單 抗(sac-TMT)已 獲NMPA批准用於EGFR-TKI和 含鉑化療治療後進展 的EGFR基 因 突 變 陽性的局部晚期或轉移性非鱗狀 NSCLC。與 標 準 治 療 相 比，蘆 康 沙 妥 珠 單 抗(sac-TMT)單一療法顯著延長 此 類 患 者 的 總 生 存 期。另外一項 蘆康沙妥珠單抗(sac-TMT)聯合奧希替尼 一線治療EGFR突變的局部晚期或轉移性非鱗狀NSCLC的III期註冊性研究 已 在中國 完成全部患者入組。 關於蘆康沙妥珠單抗(sac-TMT)（佳泰萊®） Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） ...

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, particularly focusing on innovative drugs and the recovery of left-side sectors as the biggest investment opportunities for the year [5][14]. Core Insights - The innovative drug sector is expected to continue its upward trend, with BD (business development) activities anticipated to catalyze market movements. The upcoming ESMO conference (October 17-21) is highlighted as a key event for clinical data disclosures from domestic innovative drug companies [2][13]. - The report emphasizes the importance of recent Nobel Prize discoveries related to peripheral immune tolerance, which are relevant to the development of new therapies in oncology and autoimmune diseases. This underscores the significance of innovation in these fields [40][50]. - The report notes that the CXO industry in China is entering a recovery phase, with improvements expected in industry orders, capacity utilization, and performance metrics due to enhanced domestic investment and financing data [2][5]. Summary by Sections Innovative Drugs - The innovative drug sector has seen a recent pullback, but the long-term upward trend remains intact. The report suggests that the market is awaiting further BD catalysts and highlights the importance of upcoming clinical data from the ESMO conference [2][13]. - The report indicates that the overall sentiment in the innovative drug sector is still positive, with a focus on potential breakthroughs in cancer and autoimmune therapies following the recent Nobel Prize discoveries [40][50]. Biologics - Novo Nordisk announced an agreement to acquire Akero for $4.7 billion, with Akero's FGF21 analog EFX showing promise as a leading therapy for metabolic dysfunction-related fatty liver disease (MASH) [3][51]. - The report suggests that EFX is the only drug in Phase 2 trials demonstrating significant fibrosis regression in F4 patients, highlighting the need for continued attention to developments in this area [51][57]. Medical Devices - The commercialization of innovative products is accelerating, with domestic replacements making significant progress. For instance, MicroPort's Tumi laparoscopic surgical robot has surpassed 100 global orders and is leading the domestic market share [4][58]. - The report notes that the Tumi robot has received market access in over 60 countries and regions, with a strong presence in high-end markets such as Europe [60][62]. Traditional Chinese Medicine - There has been a continuous increase in new drug IND and NDA applications for traditional Chinese medicine, with 92 new IND applications and 42 NDA applications reported in the first nine months of 2025 [3][64]. - The report highlights ongoing policy support for traditional Chinese medicine, which is expected to drive further innovation and development in this sector [64][65].

Market Performance - The Hong Kong stock market continued its decline, with notable drops in several biotech companies [1] - Innovent Biologics (09969) fell by 11.19%, closing at 14.760, with a market capitalization of 26.021 billion and a year-to-date increase of 141.18% [2] - Rongchang Biologics (09995) decreased by 10.22%, with a latest price of 95.350 and a total market value of 53.74 billion, reflecting a year-to-date increase of 562.15% [2] - WuXi AppTec (02268) and WuXi Biologics (02269) experienced declines of 5.68% and 5.32%, respectively, with market caps of 89.818 billion and 1585.28 billion [2] - Other companies such as Fuhong Hanlin (02696) and Kelun-Biotech (06990) also saw declines of over 4% [1][2] Company Highlights - Innovent Biologics has shown a significant year-to-date performance increase of 141.18% despite the recent drop [2] - Rongchang Biologics has the highest year-to-date increase among the listed companies at 562.15% [2] - WuXi Biologics and WuXi AppTec have maintained strong year-to-date increases of 120.84% and 138.50%, respectively [2] - Fuhong Hanlin and Kelun-Biotech also reported substantial year-to-date increases of 205.49% and 199.33% [2]

Core Viewpoint - The Hong Kong biopharmaceutical stocks continued to decline, with significant drops in several key companies, indicating a bearish trend in the sector [1]. Group 1: Stock Performance - Innovent Biologics (09969) experienced a decline of 11.19%, with a latest price of 14.760 and a total market capitalization of 26.021 billion, despite a year-to-date increase of 141.18% [2]. - Rongchang Biologics (09995) fell by 10.22%, with a latest price of 95.350 and a market cap of 53.747 billion, showing a remarkable year-to-date increase of 562.15% [2]. - WuXi AppTec (02268) saw a decrease of 5.68%, with a latest price of 73.100 and a market cap of 89.818 billion, maintaining a year-to-date increase of 138.50% [2]. - WuXi Biologics (02269) dropped by 5.32%, with a latest price of 38.780 and a market cap of 158.528 billion, reflecting a year-to-date increase of 120.84% [2]. - Fuhong Hanlin (02696) declined by 4.42%, with a latest price of 72.400 and a market cap of 39.349 billion, showing a year-to-date increase of 205.49% [2]. - Kelun-Biotech (06990) decreased by 4.25%, with a latest price of 488.800 and a market cap of 113.981 billion, with a year-to-date increase of 199.33% [2]. - WuXi AppTec (02359) fell by 4.19%, with a latest price of 114.400 and a market cap of 339.275 billion, reflecting a year-to-date increase of 109.21% [2]. - Gendicine (09688) saw a decrease of 2.83%, with a latest price of 25.440 and a market cap of 28.432 billion, with a year-to-date increase of 21.72% [2]. - CanSino Biologics (09926) declined by 2.05%, with a latest price of 128.800 and a market cap of 118.643 billion, reflecting a year-to-date increase of 112.19% [2]. - Junshi Biosciences (01877) fell by 2.02%, with a latest price of 29.100 and a market cap of 29.877 billion, showing a year-to-date increase of 151.30% [2].

Core Viewpoint - The domestic innovative drug industry is transitioning from a follower to FIC/BIC innovation, supported by engineer dividends, abundant clinical resources, and favorable policies, indicating a qualitative improvement as it enters the 2.0 era [1][2] Group 1: Industry Development - The innovative drug sector is expected to benefit from policy reforms in payment systems, enhancing the profitability of innovative drug companies as they commercialize domestic products [2] - The upcoming ESMO conference in mid-October is anticipated to provide new investment opportunities through the release of relevant clinical data and business development (BD) activities [2] Group 2: Investment Climate - The investment landscape has improved since early this year, with a notable reversal in the financing trend for the innovative drug industry, particularly in the A/H market [3] - The recovery of IPO projects and financing activities in the secondary market is expected to positively impact investment data in Q3, benefiting domestic CROs and upstream research sectors [3] Group 3: Policy Support - Continuous advancement of commercial medical insurance policies since 2025 is likely to accelerate payment system reforms, easing supply-demand conflicts and supporting domestic innovation [4] - Fiscal policy enhancements are expected to increase market interest in domestic medical equipment stocks [4] Group 4: Target Companies - A-share targets include: BeiGene (688235.SH), Hengrui Medicine (600276.SH), Kelun Pharmaceutical (002422.SZ), WuXi AppTec (603259.SH), Tigermed (300347.SZ), New Industry (300832.SZ), BGI Genomics (688114.SH), Huatai Medical (688617.SH), and Dian Diagnostics (300244.SZ) [5] - H-share targets include: Kelun Biotech (06990), CSPC Pharmaceutical (01093), China Biologic Products (01177), CanSino Biologics (09926), WuXi Biologics (02269), Junshi Biosciences (01877), and Zai Lab (09688) [5]