Workflow
AK112
icon
Search documents
森瑞投资董事长林存:剑指全球,中国创新药2026再启新程
Xin Lang Cai Jing· 2026-02-15 03:07
Core Viewpoint - The Chinese innovative pharmaceutical sector is entering a golden development period, presenting a once-in-a-century investment opportunity due to unmet global medical needs and significant advancements in the industry [4][9]. Group 1: Market Growth and Trends - In 2025, the total value of out-licensing (BD) transactions for Chinese innovative drugs reached $135.7 billion, a significant increase from $51.9 billion in 2024, with upfront payments rising to $7 billion from $4.1 billion [4][9]. - In January 2026 alone, the transaction volume reached $30 billion, with upfront payments of $3 billion, indicating a strong start to the year [4][9]. - The proportion of external procurement pipelines from China for multinational pharmaceutical companies surged from 10% in 2020 to 42% in 2025, highlighting China's growing importance in the global pharmaceutical landscape [4][9]. Group 2: Clinical Milestones and Innovations - 2026 is identified as a critical year for validating major drugs, with several key clinical milestones expected to emerge, potentially leading to a re-evaluation of industry value [5][9]. - Notable clinical trials include Kangfang Biotech's AK112 for non-small cell lung cancer, which is anticipated to redefine first-line treatment standards [5][9]. - The ADC sector is also poised for significant developments, with Kelong Botai's SKB264 and Baili Tianheng's BL-B01D1 expected to release important phase III clinical data [5][9]. Group 3: Impact on Related Industries - The CXO (Contract Research Organization) sector, closely tied to innovative pharmaceuticals, is expected to benefit from the technological advancements in drug development, leading to a recovery in industry sentiment [5][10]. - Companies within the "WuXi" ecosystem, such as WuXi Biologics and WuXi AppTec, are experiencing a resurgence in orders and performance, reaching historical highs despite previous unfavorable U.S. policies [10].
东方证券:IO和ADC为肿瘤头部MNC焦点 联用将迎突破
智通财经网· 2026-01-28 06:26
Group 1 - The core focus of the 2026 JPM Conference is on the strategic importance of IO (Immuno-Oncology) and ADC (Antibody-Drug Conjugates) in the oncology sector, with a significant emphasis on combination therapies [1] - The conference, held from January 12 to 15, 2026, in San Francisco, is recognized as a key event for insights into new drug development trends, capital flows, and business development collaborations in the healthcare industry [1] - Major multinational corporations (MNCs) are prioritizing second-generation IO and ADC, with a notable contribution from domestic innovations, particularly the introduction of sac-TMT by Merck as a focal point in oncology development [2] Group 2 - The exploration of combination therapies involving IO and ADC is accelerating, with multiple clinical trials underway, including 16 Phase III trials for sac-TMT and 4 Phase III trials for PD-(L)1/VEGF dual antibodies by Pfizer [2] - The year 2026 is identified as a pivotal year for the combination of IO and ADC, with expectations for increased demand for ADCs as they gain a core position in current cancer treatments [3] - Key players in the ADC market include companies such as Kangfang Biopharma, Sanofi, Rongchang Biopharma, and others, indicating a competitive landscape for ADC development [3]
创新药板块承压,益方生物等跌超3%,科创创新药ETF汇添富(589120)跌超2%,资金逆势涌入!"全球创新药春晚"JPM召开,中国创新药闪耀全球
Sou Hu Cai Jing· 2026-01-20 11:33
Core Viewpoint - The A-share market is experiencing fluctuations, particularly affecting the innovative drug sector, with the ETF Huatai Innovation Drug (589120) declining by 2.05% and facing a five-day losing streak, despite attracting over 7.9 million yuan in funds [1][3]. Group 1: Market Performance - The Huatai Innovation Drug ETF (589120) has seen a decline in its constituent stocks, with major players like I-Mab and Junshi Biosciences dropping over 3%, and others like BeiGene and Zai Lab falling more than 2% [3]. - The top ten constituent stocks of the ETF show a negative trend, with BeiGene-U down by 2.38% and Junshi Biosciences-U down by 3.42%, indicating a general downturn in the sector [3]. Group 2: Long-term Outlook - Despite the short-term market pressure, the long-term outlook for the innovative drug sector remains positive, with expectations of a clear beta market driven by liquidity recovery at the beginning of the year [4]. - The JPM conference highlighted the achievements of over 20 Chinese pharmaceutical companies, with projections for significant revenue growth in innovative drugs, such as a 25% increase for Heng Rui in 2026 [4]. Group 3: Business Development (BD) Trends - The BD activities in the sector are at a peak, with 17 transactions occurring since January, totaling approximately 10.15 billion USD in upfront payments, significantly exceeding market expectations [5]. - The ongoing trend of foreign companies expanding in China and the increasing flow of funds into the innovative drug sector suggest a favorable environment for growth and investment [5]. Group 4: Investment Strategy - The innovative drug sector is recommended for increased allocation, particularly in Hong Kong stocks, as the market is currently at a relative bottom, with potential for new historical highs [5]. - The ETF focuses on leading innovative drug companies, providing a high degree of exposure to the opportunities presented by the rise of Chinese innovative drugs [5].
REMEGEN CO LTD(9995.HK):LICENSED OUT RC148 TO ABBVIE AT DEAL SIZE OF ABBVIE AT DEAL SIZE OF US$5.6BN
Ge Long Hui· 2026-01-14 05:54
Core Viewpoint - RemeGen has entered a licensing agreement with AbbVie for RC148, which includes significant upfront and milestone payments, indicating strong market expectations for the drug's potential [1] Company Summary - RemeGen will receive an upfront payment of US$650 million and milestone payments of up to US$4.95 billion from AbbVie for the rights to develop, manufacture, and commercialize RC148 outside Greater China [1] - The licensing agreement is expected to alleviate RemeGen's cash position, which was RMB1.45 billion as of September 30, 2025 [2] Clinical Data Summary - RC148 demonstrated an overall response rate (ORR) of 61.9% and a disease control rate (DCR) of 100% in first-line PD-L1-positive NSCLC patients [2] - In combination with docetaxel for second/third-line NSCLC, RC148 showed an ORR of 66.7% and a median progression-free survival (mPFS) of 8.3 months [2] - The safety profile of RC148 is considered manageable, with clinical benefits observed across all subgroups [2] Industry Insights - The licensing-out activity in the China healthcare industry is expected to remain robust in 2026, particularly in the area of immuno-oncology (IO) [2] - The transaction reflects overseas recognition of RemeGen's R&D capabilities and highlights the competitive landscape of the PD-(L)1/VEGF market, with other companies like Pfizer also advancing their products [2]
创新药迎利好!一周五个BD,核心资产驱动不断
Zheng Quan Shi Bao· 2026-01-13 08:12
创新药迎来利好! 另外,有报道指出,艾伯维是荣昌生物合作过的药企中市值最大的一家,根据美国《制药经理人》 (Pharm Exec)杂志公布的2025年度《全球制药企业50强》排行榜,艾伯维2024财年的处方药销售数据 高达544.84亿美元,在全球药企中排名第二,与第一名强生的差距仅约2%。 值得注意的是,昨天,中国创新药核心资产——二代IO疗法发生三件大事。一是荣昌生物重磅且超预 期BD落地;二是康方生物/Summit:AK112与美国BLA申报上市;三是三生制药/辉瑞:PF- 08634404/SSGJ-707将于2026年开展五项全球多中心Ⅲ期临床试验。有分析人士认为,二代IO赛道在全 球的竞争力值得看好。 根据荣昌生物公告,1月12日,公司与艾伯维集团控股公司(以下简称"艾伯维")就RC148——一款新 型靶向PD-1/VEGF的双特异性抗体药物签署独家授权许可协议,本次交易总额最高为56亿美元(折合人 民币390亿元),首付款为6.5亿美元。 受此带动,今天创新药成为市场主角。荣昌生物A股20%涨停,港股创新药ETF上涨超3%。A股创新药 板块上涨超2.7%。诺思格(301333)、普蕊斯(3012 ...
创新药迎利好!一周五个BD,核心资产驱动不断
证券时报· 2026-01-13 08:06
Core Viewpoint - Rongchang Biopharma signed an exclusive licensing agreement with AbbVie for RC148, a novel bispecific antibody targeting PD-1/VEGF, with a total deal value of up to $5.6 billion (approximately 39 billion RMB) and an upfront payment of $650 million [1][3]. Group 1: Licensing Agreement Details - The agreement grants AbbVie exclusive rights to develop, manufacture, and commercialize RC148 outside Greater China, with Rongchang Biopharma eligible for up to $4.95 billion in milestone payments and a double-digit royalty on net sales outside Greater China [3]. - This deal marks a new high for Rongchang Biopharma in terms of both upfront payment and potential total deal value compared to previous licensing agreements since its Hong Kong listing in 2020 [3]. Group 2: Market Impact - Following the announcement, Rongchang Biopharma's A-shares hit a 20% limit up, and the Hong Kong innovative drug ETF rose over 3%, with the A-share innovative drug sector increasing by over 2.7% [1]. - Significant stock price increases were observed in companies like Nossg, Prasis, and Huaren Health [1]. Group 3: Industry Developments - In the same week, five business development (BD) deals were reported in the innovative drug sector, showcasing China's leading position across various technology fields [6]. - Notable events included the collaboration of Kangfang Biopharma with Summit for AK112's BLA submission in the U.S. and the initiation of global Phase III trials for PF-08634404/SSGJ-707 by 3SBio and Pfizer [4]. Group 4: Market Trends and Valuation - Since the peak of the Hong Kong innovative drug index in September 2025, it has retraced 24%, while the U.S. biotech indices have seen gains of 18% to 29% [7]. - Despite not being at historical lows, the valuation of Hong Kong innovative drugs remains attractive compared to global peers, indicating a growing disparity in asset values between U.S. and Chinese innovative drugs [7].
创新药,重磅!最高390亿元!一周五个BD,核心资产驱动不断
券商中国· 2026-01-13 06:25
Core Viewpoint - The article highlights a significant development in the innovative drug sector, particularly focusing on the exclusive licensing agreement between Rongchang Biopharma and AbbVie for the dual-specific antibody drug RC148, which is expected to drive market interest and stock performance in the innovative drug space [1][2]. Group 1: Licensing Agreement Details - Rongchang Biopharma signed an exclusive licensing agreement with AbbVie for RC148, a novel dual-specific antibody targeting PD-1/VEGF, with a total transaction value of up to $5.6 billion (approximately 39 billion RMB) [1][2]. - The agreement includes an upfront payment of $650 million, with potential milestone payments of up to $4.95 billion and tiered royalties on net sales outside Greater China [2]. Group 2: Market Impact - Following the announcement, Rongchang Biopharma's A-shares hit a 20% limit-up, and the Hong Kong innovative drug ETF rose over 3%, indicating strong market enthusiasm [1]. - The innovative drug sector saw a general increase, with the A-share innovative drug sector rising over 2.7%, and notable gains in companies like Nossg, Proris, and Huaren Health [1]. Group 3: Recent Developments in Innovative Drugs - The article notes that three significant events occurred in the second-generation IO therapy sector on January 12, including the successful BD deal for Rongchang Biopharma, AK112's BLA submission by Kangfang Biopharma/Summit, and the initiation of five global Phase III clinical trials for PF-08634404/SSGJ-707 by 3SBio/Pfizer [3]. - A total of five BD deals were reported in the innovative drug sector within a week, showcasing China's leading position across various technological fields [5]. Group 4: Market Trends and Valuation - According to Huatai Securities, since reaching a yearly high in September 2025, the Hong Kong innovative drug index has retraced 24%, while the US biotech indices have shown positive growth, indicating a valuation disparity between Chinese and global innovative drug assets [6]. - Despite not being at historical lows, the current valuation of Hong Kong innovative drugs remains attractive compared to global peers [6].
荣昌生物(688331):RC148授权艾伯维,进入大药postBD阶段
Huaan Securities· 2026-01-13 05:33
Investment Rating - The investment rating for Rongchang Biologics (688331) is "Buy" (maintained) [2] Core Insights - On January 12, 2026, Rongchang Biologics announced an exclusive licensing agreement with AbbVie for its self-developed PD-1/VEGF bispecific antibody drug RC148. AbbVie will receive exclusive rights for development, production, and commercialization outside Greater China, with an upfront payment of $650 million and potential milestone payments up to $4.95 billion, along with double-digit royalties on net sales outside Greater China [5][11] - The deal is seen as a significant entry into the business development (BD) market for 2026, highlighting the growing trend of large licensing transactions in the PD-1/VEGF space, which is crucial for next-generation cancer immunotherapy [6] - AbbVie, a well-established player in oncology, aims to enhance treatment standards for patients with difficult-to-treat cancers, and the acquisition of RC148 will further strengthen its pipeline in immuno-oncology [7] Financial Projections - Revenue projections for Rongchang Biologics are adjusted to 2.25 billion, 7.42 billion, and 3.98 billion yuan for 2025, 2026, and 2027 respectively, reflecting year-on-year growth rates of 31.1%, 229.6%, and -46.3% [11] - The net profit attributable to the parent company is expected to be -763 million, 3.19 billion, and 220 million yuan for the same years, with growth rates of 48.0%, 517.8%, and -93.1% [11] - The gross margin is projected to remain stable, increasing from 80.4% in 2024 to 82.2% in 2027 [13]
森瑞投资林存:创新药2026年开了个好头!|生物医药大健康2026思享汇
Jin Rong Jie· 2026-01-09 10:43
Core Insights - The biopharmaceutical industry is at a pivotal moment as it transitions from the "14th Five-Year Plan" to the "15th Five-Year Plan," emphasizing the balance between technological innovation and value-driven growth [1] - The recent surge in the innovative drug sector, with the Shanghai Composite Index achieving a 14-day winning streak and the Hong Kong innovative drug index rising by an average of 12% over three days, indicates strong market support for innovative pharmaceuticals [4] - The Chinese government has reinforced its commitment to the innovative drug sector through policies like "Full Chain Support for Innovative Drug Development," which is expected to create significant industry opportunities [4] Industry Growth Drivers - Innovative drugs are recognized as a critical new productive force, comparable in priority to AI and other emerging technologies, with substantial government backing [4] - In 2025, China signed over 150 new business development (BD) agreements in the innovative drug sector, totaling more than $130 billion, a 150% increase from 2024, with upfront payments reaching $7 billion [5] - The anticipated "milestone" rewards from these agreements could exceed $30 billion in the next 3-5 years, fostering the growth of China's innovative drug market despite inherent development risks [5] Market Dynamics - The global biopharmaceutical development landscape is revitalizing due to expiring drug patents and a favorable interest rate environment, with major pharmaceutical companies increasing their R&D investments [6] - The emergence of blockbuster innovative drugs in China, such as AK112 and SKB264, showcases the potential for significant sales in the global market, with some products challenging established leaders [6][7] - The international geopolitical climate is expected to enhance China's economic prospects, leading to increased capital inflows into A-shares and Hong Kong stocks, signaling the onset of a major bull market [7] Future Outlook - The period between 2026 and 2027 is anticipated to yield significant clinical breakthroughs in innovative drugs, potentially leading to substantial stock price revaluations [7] - The next 20 years are projected to be a prosperous era for China, with substantial returns expected for those following technological innovations in the biopharmaceutical sector [8]
2026:或许是决定创新药国运的一年
Xin Lang Cai Jing· 2026-01-09 00:55
Core Viewpoint - The article discusses the potential impact of AK112, a PD-1×VEGF dual antibody developed by Kangfang, on the future of innovative drugs in China, suggesting it could lead to significant changes in the market dynamics over the next 3-5 years [1][16]. Group 1: AK112's Market Performance - AK112 has been approved for the Chinese market and shows promising results in treating EGFR mutation patients with non-small cell lung cancer (NSCLC), with a progression-free survival (PFS) of 7.06 months compared to 4.8 months for chemotherapy, and a hazard ratio (HR) of 0.46 [2][17]. - The overall survival (OS) data for AK112 is less impressive, with a median survival of 16.8 months for the combination therapy versus 14.1 months for chemotherapy, resulting in a risk ratio of 0.74 (p=0.019) [2][17]. Group 2: Challenges and Concerns - A small issue is identified regarding the limited market size for EGFR TKI resistant treatments, which constitutes only 4% of the total NSCLC market, suggesting limited impact on overall sales [2][18]. - A significant concern arises from the OS data being statistically insignificant (HR=0.79, p=0.057), which could hinder the drug's acceptance and market potential [3][18]. Group 3: Future Trials and Implications - The success of future trials, particularly Harmoni-2 and Harmoni-6, is crucial for AK112's market position. Harmoni-2 has already been approved, while Harmoni-6 is critical for first-line treatment of squamous NSCLC [6][21]. - If Harmoni-6 fails to demonstrate significant OS benefits, it could jeopardize the global clinical value of AK112 and lead to negative repercussions for other companies involved in PD-1×VEGF dual antibodies [6][22]. Group 4: Market Trends and Investment Opportunities - The innovative drug sector has seen a resurgence in the secondary market, particularly in Hong Kong, with the Hang Seng Innovation Drug Index showing over a 10% increase in 2026 [13][25]. - The index offers unique advantages, including a focus on pure innovative drugs, a high concentration of leading companies, and controlled risks through liquidity management [14][28].