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荣昌生物(09995)与艾伯维就RC148签署独家授权许可协议
智通财经网· 2026-01-12 12:58
Core Viewpoint - Rongchang Biopharmaceutical (09995) has signed an exclusive licensing agreement with AbbVie for its new dual-specific antibody drug RC148, targeting PD-1/VEGF, which will provide significant financial benefits to the company upon regulatory approval [1] Group 1: Agreement Details - The agreement grants AbbVie exclusive rights to develop, manufacture, and commercialize RC148 outside of Greater China [1] - Upon regulatory approval, the company will receive an upfront payment of $650 million [1] - The company is eligible for up to $4.95 billion in milestone payments related to development, regulatory, and commercialization achievements [1] Group 2: Financial Implications - The agreement includes tiered royalties on net sales outside of Greater China, which are expected to be in double digits [1] - The total potential milestone payment amount remains uncertain as it is contingent upon meeting specific conditions [1]
荣昌生物(09995) - 内幕消息 - 与艾伯维签署授权许可协议的公告
2026-01-12 12:50
本公告由榮昌生物製藥(煙台)股份有限公司(「本公司」)根據香港聯合交易所有限 公司證券上市規則(「上市規則」)第13.09(2)條及證券及期貨條例(香港法例第571 章)第XIVA部項下的內幕消息條文(定義見上市規則)作出。 協議概述 本公司董事(「董事」)會(「董事會」)欣然宣佈,於2026年1月12日(交易時段後), 本公司與艾伯維集團控股公司(以下簡稱「艾伯維」)就RC148簽署獨家授權許可協 議(以下簡稱「協議」)。RC148是本公司研發的一款新型靶向PD-1/VEGF的雙特異 性抗體藥物。根據協議,艾伯維將獲得RC148在大中華區以外地區的(以下簡稱 「合作範圍」)的開發、生產和商業化的獨家權利。協議經相關監管批准生效後, 本公司將收到6.5億美元的首付款,並有資格獲得最高達49.5億美元的開發、監管 和商業化里程碑付款,以及在大中華區以外地區淨銷售額的兩位數分級特許權使 用費。協議中所約定的里程碑付款需要滿足一定的條件,本公司最終可實現的里 程碑付款金額尚存在不確定性。 本次交易已經董事會審議通過,無需提交股東會審議。 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之內容概不負責,對其準 ...
HER2 ADC缩圈,国内玩家Live or Die?
3 6 Ke· 2026-01-12 04:26
Core Viewpoint - Enhertu (DS-8201) has evolved into a "complete entity" with the recent approval for first-line therapy in HER2+ breast cancer, marking significant progress from its initial approval as a third-line therapy in December 2019 to its current status [1][2] Group 1: Enhertu's Progression - Enhertu's journey includes approvals for HER2+ breast cancer in third-line therapy (December 2019), second-line therapy (January 2021), and now first-line therapy [2] - The first-line therapy approval is in combination with pertuzumab, with expectations for single-agent approval in the future [2] Group 2: Competitive Landscape - The HER2 ADC breast cancer market is approaching a critical phase, with companies like Rongchang Biopharma, Kelun-Biotech, and BaiLi Tianheng adopting various strategies to compete [3][6] - Rongchang Biopharma has focused on differentiated strategies, avoiding direct competition in breast cancer and targeting unmet clinical needs in other indications like gastric cancer [4][6] - Kelun-Biotech has actively pursued HER2+ breast cancer, achieving approval for its product A166 as the first domestic ADC for second-line therapy, leveraging a strategy of gradual advancement [7][9] Group 3: Strategic Approaches - BaiLi Tianheng aims to create a competitive product against Enhertu, with its T-Bren ADC targeting both HER2+ breast cancer and non-small cell lung cancer (NSCLC) [11][14] - HengRui Medicine adopts a multi-cancer strategy, focusing on various indications beyond breast cancer, with its SHR-A1811 ADC already approved for HER2-mutated NSCLC [16][17] Group 4: Differentiated Strategies - Lepu Biopharma's strategy centers on combining its ADC with PD-1 therapies, positioning its products as complementary rather than direct competitors [18][20] - In contrast, YingEn Biopharma has established a global strategy, securing a partnership with BioNTech for its DB-1303 ADC, focusing on unmet needs in endometrial cancer [22][24] Group 5: Future Outlook - The competitive landscape in the HER2 ADC market is intensifying, with companies employing diverse strategies to carve out their niches [26] - The future success in this sector may hinge on the depth of differentiated strategies and the ability to commercialize effectively, rather than solely on product efficacy [26]
创新药午后蹿升!骨髓瘤注射液获上市审批,智翔金泰大涨超8%,科创创新药ETF汇添富(589120)涨超3%,强势反包!创新药2026投资前瞻来了
Sou Hu Cai Jing· 2026-01-09 06:05
Core Viewpoint - The A-share market is experiencing a significant upward trend, with the Shanghai Composite Index returning to 4100 points for the first time in 10 years, driven by a strong performance in the innovative pharmaceutical sector, particularly the Sci-Tech Innovation Drug ETF Huatai (589120) which rose over 3% [1] Group 1: Market Performance - The Sci-Tech Innovation Drug ETF Huatai (589120) saw most of its constituent stocks surge, with notable increases such as Yuekang Pharmaceutical up over 10%, Zhixiang Jintai up over 8%, and Micron Biologics up over 6% [3] - The top ten constituent stocks of the ETF include major players in the pharmaceutical sector, with BeiGene (688235) rising by 1.77% and Aier Eye Hospital (688578) increasing by 2.18% [3] Group 2: Regulatory Support - A national drug supervision conference held from January 6 to 7 emphasized the need to actively support the pharmaceutical industry in enhancing quality and efficiency, alongside comprehensive reforms in drug regulation [4] Group 3: Innovation and Drug Approvals - Innovation remains a key theme in the Sci-Tech Innovation Drug sector, with recent announcements including Zhixiang Jintai's conditional listing application for a dual-antibody drug and Micron Biologics receiving approval for clinical trials of a new drug for pancreatic cancer [5] - BeiGene announced the conditional approval of its new BCL2 inhibitor, providing new treatment options for patients with chronic lymphocytic leukemia [6] - Rongchang Biologics is seeking breakthrough therapy designation for a new indication of its drug, which would mark a significant regulatory achievement for domestic ADC products [7] Group 4: Future Outlook - The Pacific Securities report anticipates that by 2026, the innovative drug sector will benefit from enhanced international capabilities and supportive industry policies, leading to increased market confidence and investment [8] - The report highlights that the average deal value for innovative drugs purchased from China by top multinational corporations is significantly higher than those from overseas, indicating a growing recognition of the value of Chinese innovative drugs in the global market [9]
A股异动丨国家药监局重磅发声,创新药概念股集体走强,必贝特创上市新高
Ge Long Hui A P P· 2026-01-08 02:27
Group 1 - The A-share market continues to show strength in innovative drug concept stocks, with notable gains from companies such as Bibot-U nearing the daily limit and reaching a new high, and Yuandong Bio rising over 9% [1] - The National Medical Products Administration (NMPA) is set to support the "China debut" of innovative drugs, with plans to implement a data protection system for drug trials and establish exclusive market periods for pediatric and rare disease medications by 2026 [1] - The NMPA has announced further optimization of the review and approval process for urgently needed foreign drugs already on the market to meet the pressing clinical needs of patients [1] Group 2 - Notable stock performances include Bibot-U with a 19.95% increase, Yuandong Bio up 9.33%, and Hongbo Pharmaceutical rising 8.16%, among others [2] - The total market capitalization for Bibot-U is 22.3 billion, while Yuandong Bio stands at 11.5 billion, and Hongbo Pharmaceutical at 4.867 billion [2] - Year-to-date performance shows Bibot-U leading with a 70.89% increase, followed by Hongbo Pharmaceutical at 16.74% and Lai Mei Pharmaceutical at 7.59% [2]
创新药领衔科技IPO突围!全市场孤品·创新药ETF天弘(517380)标的指数冲击五连阳,昨日净流入近9000万元,创25年4月以来新高!
Sou Hu Cai Jing· 2026-01-08 02:22
Core Viewpoint - The innovative drug ETF Tianhong (517380) has seen significant trading activity and growth, indicating a strong interest in the innovative drug sector, which is experiencing a historic surge in IPOs and commercialization efforts [1][4]. Group 1: ETF Performance - As of January 8, 2026, the innovative drug ETF Tianhong (517380) recorded a transaction volume of 18.58 million yuan, with the tracked index HSSSHID rising by 0.92% [1]. - The latest scale of the innovative drug ETF Tianhong reached 1.578 billion yuan, with a total of 1.962 billion shares, both marking all-time highs since its inception [2]. - The net inflow of funds into the innovative drug ETF Tianhong was 89.42 million yuan, the highest since April 2025 [3]. Group 2: Market Trends - The innovative drug sector is experiencing a "volume and price increase" opportunity, with the top ten constituent stocks of the ETF heavily weighted towards leading companies like WuXi AppTec and HengRui Medicine, benefiting from a surge in business development (BD) transactions and breakthroughs in AI drug development [3]. - In 2025, the innovative drug sector achieved a historic explosion, with over 30 biotech companies successfully listed in A-shares and Hong Kong, and more than 50 companies awaiting approval, reflecting unprecedented capital activity [4]. - The sector has transitioned from mere speculation to substantial commercialization, becoming a benchmark sector with both growth potential and certainty in the current bull market [4]. Group 3: Institutional Insights - Southwest Securities noted that in early 2025, Hong Kong companies began achieving BD, leading to a rise in the innovative drug sector; a government report in March emphasized support for innovative drugs and medical devices, further boosting A-share performance [5]. - The sector experienced a significant price increase following a major BD deal worth 1.25 billion USD in May, but faced a high-level adjustment by the end of the third quarter [5]. - The firm predicts that in 2026, the innovative drug sector will shift from a broad rally to a selective stock market [5].
ETF日报|见证历史,沪指14连阳逼空!创新药逆市领涨港股,520880大涨超3%!人工智能还看创业板,159363再创新高
Sou Hu Cai Jing· 2026-01-07 13:46
Core Viewpoint - The A-share market is experiencing a historic moment with the Shanghai Composite Index recording a 14-day winning streak, while the Hong Kong market shows weakness, particularly in technology stocks. However, innovative drug ETFs are performing well, indicating strong investor interest in the healthcare sector [1][3][4]. ETF Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) has risen over 3%, marking three consecutive days of gains, while the overall market shows mixed results. The Pharmaceutical ETF (562050) also recorded three consecutive daily gains, indicating a strong performance in the pharmaceutical sector [1][3][4]. - The largest medical ETF in the market (512170) is approaching its six-month line, reaching a new 20-day high, reflecting positive momentum in the healthcare sector [1][3][4]. Sector Highlights - The pharmaceutical sector is significantly outperforming the broader market, with leading innovative drug companies like Rongchang Bio surging over 11%. The overall performance of the pharmaceutical ETF indicates a strong bullish sentiment among investors [3][4]. - The AI application sector is also gaining traction, with the Entrepreneurial Board AI ETF (159363) reaching a new high, supported by strong performance in AI hardware and applications [9][11]. Market Outlook - Huaxi Securities suggests that the current market dynamics indicate an early spring rally, maintaining a bullish outlook. Key investment themes include emerging growth sectors and opportunities arising from anti-involution trends, particularly in AI, robotics, and renewable energy [2][20]. - The outlook for the metals sector remains optimistic, driven by macroeconomic factors such as potential interest rate cuts by the Federal Reserve and strong demand in traditional and emerging industries [13][15]. Investment Recommendations - Analysts recommend focusing on sectors benefiting from policy support, such as AI computing chains, robotics, and domestic replacements, as well as sectors poised for price increases like chemicals and non-ferrous metals [2][20]. - The innovative drug and medical device sectors are highlighted as key areas for investment, with a focus on companies that are expected to maintain strong growth trajectories through 2026 [7][20].
荣昌生物(09995) - 截至二零二五年十二月三十一日止月份之股份发行人的证券变动月报表
2026-01-07 09:39
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 榮昌生物製藥(煙台)股份有限公司 呈交日期: 2026年1月7日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09995 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 2. 股份分類 | 普通股 | 股份類別 | A ...
生物制品板块1月7日涨0.61%,荣昌生物领涨,主力资金净流入1.58亿元
Core Insights - The biopharmaceutical sector experienced a rise of 0.61% on January 7, with Rongchang Biopharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 4085.77, up 0.05%, while the Shenzhen Component Index closed at 14030.56, up 0.06% [1] Stock Performance - Rongchang Biopharmaceutical (688331) closed at 91.24, with a significant increase of 11.13%, and a trading volume of 129,800 shares, amounting to 1.134 billion yuan [1] - Other notable performers included Buyuan Biopharmaceutical (688765) with a closing price of 78.16, up 8.14%, and Aidi Pharmaceutical (688488) at 17.45, up 6.73% [1] - The overall trading volume and turnover for the biopharmaceutical sector indicated strong investor interest, with Rongchang Biopharmaceutical leading in both metrics [1] Capital Flow - The biopharmaceutical sector saw a net inflow of 158 million yuan from institutional investors, while retail investors experienced a net outflow of 163 million yuan [2] - The data indicates a mixed sentiment among different investor types, with institutional investors showing confidence in the sector [2][3] Individual Stock Capital Flow - Rongchang Biopharmaceutical had a net inflow of 128 million yuan from institutional investors, while retail investors showed a net outflow of approximately 50 million yuan [3] - Other companies like Ganli Pharmaceutical (603087) and Junshi Biosciences (688180) also experienced net inflows from institutional investors, indicating a trend of institutional support for select stocks within the sector [3]
港股创新药板块尾盘持续拉升,荣昌生物涨超13%
Xin Lang Cai Jing· 2026-01-07 07:16
港股创新药板块尾盘持续拉升,荣昌生物涨超13%,泰格医药、凯莱英涨超9%,药明生物、信达生物 涨超5%。 ...