Core Insights - The company Kolonbo Tai Biotech-B (06990) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Bodo Trastuzumab) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have previously received one or more anti-HER2 therapies [1][2] Group 1 - The approval is based on a multicenter, randomized, open-label, controlled Phase 3 study (KL166-III-06) that evaluated the efficacy and safety of Bodo Trastuzumab compared to T-DM1 in HER2-positive patients with unresectable or metastatic BC who had previously received trastuzumab and taxane treatments [1] - In the pre-specified interim analysis, Bodo Trastuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to T-DM1, as assessed by blinded independent central review (BICR) [1] - A trend towards improved overall survival (OS) with Bodo Trastuzumab was also observed, with results set to be presented at the 2025 European Society for Medical Oncology (ESMO) conference in Berlin [1] Group 2 - The company has initiated an open-label, multicenter Phase 2 clinical study of Bodo Trastuzumab for the treatment of HER2-positive unresectable or metastatic BC previously treated with an effective payload of topoisomerase inhibitor ADC [2] - Bodo Trastuzumab is a differentiated HER2 ADC designed for the treatment of advanced HER2-positive solid tumors, featuring a drug-antibody ratio (DAR) of 2 [2] - The drug specifically binds to HER2 on the surface of tumor cells, leading to internalization and release of the cytotoxic molecule Duo-5, which induces cell cycle arrest in the G2/M phase and triggers apoptosis in tumor cells [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。 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） （股 份 代 號：6990） 自願公告 核心產品博度曲妥珠單抗治療2L+ HER2+乳腺癌 獲國家藥品監督管理局批准上市 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 靶 向 人 類 表 皮 生 長 因 子 受 體2(HER2)的抗體偶聯 藥 物(ADC)博 度 曲 妥 珠 單 抗（亦 稱A166）（舒泰萊®）獲 國 家 藥 品 監 督 管 理 局 (NMPA)批准用於既往接受過一種或一種以上抗HER2藥物治療的不可切 除 ...

Group 1 - A-shares and Hong Kong stocks in the innovative pharmaceutical sector have rebounded, with significant gains in related stocks and ETFs [1][3][5] - The largest medical ETF in A-shares (512170) saw a trading volume of 589 million yuan, recovering 1.34% on the day [1] - The innovative drug sector is experiencing a collective rise, with notable stocks like Huahai Pharmaceutical increasing by 7.59% [3] Group 2 - The Hong Kong innovative drug ETF (520880) rose by 2.12%, with 35 out of 37 constituent stocks gaining, led by Green Leaf Pharmaceutical with an 8.31% increase [5][7] - Recent funding trends indicate a significant inflow into the innovative drug sector, with over 1.29 billion yuan added in the last three days [7] - Upcoming catalysts include the European Society for Medical Oncology (ESMO) annual meeting, which may showcase significant research results from Chinese innovative drugs [7] Group 3 - Investment strategies suggest focusing on innovative drugs, with specific ETFs like the Hong Kong innovative drug ETF (520880) and the A-share drug ETF (562050) highlighted for their potential [8] - The medical ETF (512170) is noted for its inclusion of CXO companies, which account for 26.77% of its weight [8] - The medical ETF is the largest in the market, with a scale of 26.4 billion yuan, while the drug ETF is the only one tracking the China Pharmaceutical Index [9]

Core Viewpoint - The innovative drug sector experienced a significant rally, with the innovative drug index rising by 2.35% as of the midday close on October 15, 2025, driven by strong performances from various companies [1][2]. Group 1: Market Performance - The innovative drug index (886015.TI) closed at 1366.835, reflecting a gain of 2.35%, equivalent to an increase of 31.422 points [2]. - Notable stock performances included Guangshentang, which surged by 20% to 122.65, and several other companies such as Shutaishen and Anglikang, which saw gains of 14.4% and 10.01%, respectively [2][3]. Group 2: Upcoming Events - The European Society for Medical Oncology (ESMO) conference is set to take place from October 17 to 21, 2025, in Berlin, Germany, where significant clinical research results and data are expected to be disclosed [3][4]. Group 3: Business Development Opportunities - There is growing market anticipation for the release of clinical data from domestic innovative drugs and business development (BD) collaborations, with 83 overseas BD transactions recorded in the first eight months of 2025, totaling 845 billion yuan, marking a 62.81% increase compared to the entire year of 2024 [4]. Group 4: Company Earnings Forecast - Several innovative drug companies are expected to report strong earnings for the third quarter of 2025, with Shengnuo Bio projecting a net profit of 114 million to 140 million yuan, representing a year-on-year increase of 100.53% to 145.10% [5]. - Boteng Co. anticipates a net profit of 73.2 million to 88.2 million yuan, indicating a turnaround from losses, driven by a 17% to 21% increase in revenue [5]. Group 5: Industry Outlook - Analysts express optimism regarding the innovative drug sector, anticipating stabilization and rebound due to upcoming catalysts such as BD and medical insurance negotiations [6]. - Long-term trends indicate that the Chinese pharmaceutical industry has transitioned to new growth drivers, particularly in innovative drugs, which are expected to significantly contribute to the growth of Chinese pharmaceutical companies over the next 5 to 10 years [7].

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） ...