Investment Rating - The report maintains a "Buy" rating for the company, Kolun Botai Biopharmaceutical-B (06990) [1][9] Core Insights - Kolun Botai's core product, sac-TMT (Lukangshatuozhuzhujun), has accelerated commercialization with multiple indications approved by NMPA, including breast cancer and lung cancer treatments [5][6] - The company reported a revenue of 2.058 billion yuan for 2025, a year-on-year increase of 6.5%, with a significant increase in drug sales revenue by 949.4% [4][9] - The company has established a mature commercialization team of over 600 people, covering 30 provinces and more than 1,200 hospitals, indicating strong market penetration [5][6] Financial Performance - The company experienced a net loss of 382 million yuan in 2025, with adjusted losses of 211 million yuan, primarily due to increased R&D expenses and a decline in licensing and collaboration revenue [4][9] - The gross profit for 2025 was 1.479 billion yuan, with a gross margin of 71.9%, reflecting a 6 percentage point increase year-on-year [4][9] - Cash and financial assets reached 4.559 billion yuan, a year-on-year increase of 48.2% [4] Revenue Forecast - Projected revenues for 2026, 2027, and 2028 are 2.377 billion yuan, 3.299 billion yuan, and 6.016 billion yuan, respectively, with growth rates of 16%, 39%, and 82% [9][10] - The company anticipates a return to profitability by 2027, with a projected net profit of 296 million yuan and a significant increase to 1.201 billion yuan by 2028 [10][11] Clinical Development - sac-TMT is involved in 17 global Phase 3 clinical trials, targeting various cancers, with promising data expected to be released soon [6][7] - The drug has shown superior efficacy in clinical trials, with an objective response rate of 45.1% compared to 15.6% for chemotherapy in patients with EGFR-TKI and platinum-based chemotherapy failures [7]

Investment Rating - The report maintains a "Buy" rating for WuXi XDC [4][17]. Core Insights - WuXi XDC reported a revenue of RMB 5.94 billion for 2025, representing a year-on-year growth of 46.7%, and a net profit of RMB 1.48 billion, up 38.4% year-on-year. The adjusted net profit reached RMB 1.56 billion, reflecting a 70.0% increase, aligning with expectations [7][13]. - The company experienced significant growth in overseas revenue, with North America and Europe revenues increasing by 49% and 129% year-on-year, respectively, contributing to 76% of total revenue [8][14]. - The total backlog of orders grew by 50.3% year-on-year to USD 1.5 billion, with the cumulative number of customers increasing from 499 in 2024 to 643 in 2025 [9][15]. - WuXi XDC is expanding its production capacity through strategic acquisitions, including the acquisition of BioDlink, which is expected to enhance its production capabilities and customer base [10][16]. Financial Data and Earnings Forecast - The projected revenue for WuXi XDC is expected to reach RMB 8.06 billion in 2026, with a year-on-year growth rate of 35.64% [11][19]. - The adjusted earnings per share (EPS) forecast for 2026 has been raised from RMB 1.68 to RMB 1.69, with further increases projected for 2027 and 2028 [17].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company achieved total revenue of 2.058 billion yuan in 2025, representing a year-on-year increase of 6.5%. The revenue from drug sales surged by 949.8% to 543 million yuan, primarily due to the approval of new indications for its main products [8] - The commercialization of the core product, Sac-TMT, is progressing smoothly, with expectations for rapid growth as it covers over 30 provinces and 2,000 hospitals in China. Key indications have been included in the national medical insurance directory [8] - The company has a robust pipeline with multiple clinical trials ongoing, including four approved indications for Sac-TMT and several others in advanced stages. The ADC platform is also showing significant progress with multiple candidates entering clinical phases [8] Financial Summary - Total revenue projections for the company are 3.56 billion yuan in 2026, 5.89 billion yuan in 2027, and 7.66 billion yuan in 2028, indicating substantial growth rates of 72.99%, 65.56%, and 30.03% respectively [1][9] - The net profit is expected to turn positive by 2027, with a forecasted net profit of 649.8 million yuan, and further increasing to 1.62 billion yuan by 2028 [1][9] - The company maintains a strong cash position, with cash and financial assets exceeding 4.542 billion yuan, reflecting a 48% increase [8]

Core Viewpoint - Rongchang Biopharmaceutical (09995) has received approval from the National Medical Products Administration of China for the drug registration certificate of Vedisituzumab (RC48), which is now approved for a new indication in treating HER2 low-expressing breast cancer with liver metastasis [1][2] Group 1: Drug Approval Details - The new indication is for adult breast cancer patients with unresectable or metastatic HER2 low-expressing (IHC 1+ or IHC 2+/ISH-) who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after completing adjuvant chemotherapy [1] - This approval is based on data from a randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China, which demonstrated good efficacy and safety for Vedisituzumab in this specific patient population [1] Group 2: Product Background - Vedisituzumab is the first original ADC independently developed in China, targeting the HER2 protein on tumor cells, and has achieved world-leading clinical data in trials for gastric cancer, urothelial carcinoma, and breast cancer [2] - With this latest approval, Vedisituzumab is now approved for four indications in China: HER2 overexpressing locally advanced or metastatic gastric cancer; HER2 overexpressing locally advanced or metastatic urothelial carcinoma; HER2 positive with liver metastasis in advanced breast cancer; and HER2 low-expressing with liver metastasis in breast cancer [2]

Core Viewpoint - Rongchang Biopharmaceutical (09995) has received approval from the National Medical Products Administration of China for the drug registration certificate of Vidixtimab (RC48), which is now approved for a new indication in treating HER2 low-expressing breast cancer with liver metastasis [1][2] Group 1 - The new indication is for adult breast cancer patients with unresectable or metastatic HER2 low-expressing (IHC 1+ or IHC 2+/ISH-) tumors who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy [1] - This approval is based on data from a randomized, open-label, parallel-controlled, multi-center Phase III clinical trial (RC48-C012) conducted in China, which demonstrated good efficacy and safety for Vidixtimab in this specific patient population [1] Group 2 - Vidixtimab is the first original ADC independently developed in China, targeting the HER2 protein on tumor cells, and has achieved world-leading clinical data in trials for gastric cancer, urothelial carcinoma, and breast cancer [2] - With this latest approval, Vidixtimab is now approved for four indications in China: HER2 overexpressing locally advanced or metastatic gastric cancer; HER2 overexpressing locally advanced or metastatic urothelial carcinoma; HER2 positive with liver metastasis in advanced breast cancer; and HER2 low-expressing with liver metastasis in breast cancer [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，並表明概不就因本公告全部或任何部份內容而產生或因依賴該等 內容而引致的任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）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：9995） 自願公告 批准維迪西妥單抗用於治療HER2低表達且 存在肝轉移的乳腺癌適應症上市申請 本公告乃由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司已收到中國國家藥品監督管理局（「中 國藥監局」）核准簽發的藥品註冊證書。維迪西妥單抗（代號：RC48，商品名：愛 地希®，批准文號：國藥准字S20210017，證書編號：2026S00808）用於治療HER2 低表達且存在肝轉移的乳腺癌的新適應症上市申請獲得批准。這是維迪西妥單抗 在國內獲批的第四項適應症。 於本公告日期，本公司董事會成員包括執行董事王威東先生、房健民博士、 溫慶凱先生及林健先生；非執行董事王荔強博士及蘇曉迪博士；及獨立非執行 董事郝先經 ...

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Insights - The report highlights the acceleration of domestic innovation in China, transitioning from "follow" to "first" in the pharmaceutical and biotechnology sector, particularly in areas such as second-generation immune combination therapies, single/double antibody ADCs, and AI-assisted diagnostics [5][14][15] - The report emphasizes significant survival benefits from ADC drugs in the treatment of EGFRm NSCLC and SCLC, indicating a paradigm shift in treatment approaches [6][21][22] Summary by Sections 1. Chinese Leadership in ADC Era - ELCC 2026 showcases China's rapid innovation in the pharmaceutical sector, with a focus on advanced therapies and AI applications [5][14] - Key studies presented at ELCC 2026 include sac-TMT (Trop2 ADC) and Iza-bren (EGFR/HER3 ADC), demonstrating promising clinical outcomes [15][17] 2. Market Performance - The pharmaceutical and biotechnology sector experienced a decline of 2.77% in March, underperforming the CSI 300 index by 0.59 percentage points [24] - Among sub-sectors, the in vitro diagnostics segment showed the smallest decline, while the hospital sector faced the largest drop [27] 3. Recommended Stocks - Monthly recommended stocks include WuXi AppTec, CSPC Pharmaceutical, Innovent Biologics, and others [8] - Weekly recommended stocks include Heng Rui Medicine, Kelun Pharmaceutical, and others [8]

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Insights - The report highlights the acceleration of domestic innovation in the pharmaceutical and biotechnology sector, showcasing a shift from "follow" to "first" in local innovation, particularly in areas such as second-generation immune combination therapies, single/double antibody ADCs, and AI-assisted diagnostics [5][14][15] - The report emphasizes significant survival benefits from ADC drugs in the treatment of EGFRm NSCLC and SCLC, indicating a paradigm shift in treatment approaches [6][21] Summary by Sections 1. Domestic Leadership in ADC Era - ELCC 2026 will focus on key areas such as second-generation immune combination therapies and targeted therapies for KRAS/HER2/EGFR [5][14] - Notable studies presented at ELCC 2026 include sac-TMT (Trop2 ADC) by Kelun-Biotech and Iza-bren (EGFR/HER3 ADC) by BaiLi Tianheng, among others [15][16] 2. Market Performance - The pharmaceutical and biotechnology sector experienced a decline of 2.77% in March, underperforming the CSI 300 index by 0.59 percentage points [24][27] - Among sub-sectors, the in vitro diagnostics segment had the smallest decline, while the hospital sector faced the largest drop [27][28] 3. Recommended Stocks - Monthly recommended stocks include WuXi AppTec, CSPC Pharmaceutical, Innovent Biologics, BaiLi Tianheng, and others [8] - Weekly recommended stocks include HengRui Medicine, Kelun-Biotech, and others [8]

Core Insights - The company has reported an upward trend in the market price of experimental monkeys and has taken measures to ensure a stable supply to meet operational needs [3][4] - The growth of the company's overseas business is driven by a deepened global layout, improved business systems, and enhanced comprehensive service capabilities [4][6] - The company is focusing on building innovative technology platforms related to human cell models, AI predictions, and organoids, while also strengthening its preclinical capabilities in biopharmaceuticals [5][6] Group 1: Supply and Pricing - The market price of experimental monkeys has been increasing recently, prompting the company to diversify procurement channels and deepen cooperation with suppliers to ensure a stable supply [3][4] Group 2: Overseas Business Growth - The company's overseas business growth is attributed to a comprehensive global strategy, including the establishment of a 2,000 square meter R&D office in Boston, which has already begun generating revenue [4][6] - The company is enhancing its laboratory capabilities and business team configurations in key overseas regions, improving communication between overseas business development and domestic research teams [4][6] Group 3: Technology Platform Development - The company is advancing its innovative technology platforms, focusing on areas such as CGT, nucleic acid drugs, PROTAC, and AI, with ongoing projects in ADC preclinical research [5][6] - The company has completed numerous ADC preclinical studies and received 30 approvals, indicating a strong capability in this area [5][6] Group 4: Capacity and Talent Management - The company operates R&D laboratories in multiple locations, including Zhangjiang, Chuansha, Nanhui, and Boston, with ongoing expansion projects to enhance drug discovery and research capabilities [6][7] - The company plans to dynamically recruit talent based on business needs, focusing on technical and management personnel, while also implementing internal training and incentive mechanisms [6][7] Group 5: Project Execution Cycles - The company has three service models with varying execution cycles: product customization (1-3 months for chemical/biological services, 1-10 months for pharmacodynamics), design and development (approximately 6 months to 2.5 years), and joint efforts (typically 6 months to 1 year) [8]

Core Viewpoint - Rongchang Biopharma (09995) has seen its stock price increase by over 5%, currently trading at 90 HKD, following the acceptance of its RC288 injection application by NMPA, indicating strong market interest in its innovative drug pipeline [1] Group 1: Product Development - The RC288 injection, developed by Rongchang Biopharma, is a PSMA/B7H3 ADC that has demonstrated excellent anti-tumor activity and safety in preclinical studies [1] - The company is expected to enter a new growth phase starting in 2026, primarily driven by the launch of new indications for RC18, RC48, and RC28, which will also be included in medical insurance [1] Group 2: Future Revenue Streams - Sales from overseas indications for RC48 and RC18 are projected to begin in 2027, contributing to revenue through sales sharing agreements [1] - Starting in 2025, the company anticipates multiple asset licensing agreements, with upfront payments and milestones expected to enhance financial statements in the coming years [1] Group 3: Competitive Positioning - The newly entered global FIC pipeline, including CDCP1 ADC RC278 and B7H3/PSMA ADC RC288, holds potential global competitiveness and may lead to external licensing opportunities [1]