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中国创新药企破纪录！三生制药与辉瑞百亿BD引爆全球双抗赛道
015303SBIO(01530) 新浪证券·2025-05-27 08:41

Core Insights - Chinese innovative pharmaceutical company 3SBio has entered a record-breaking License out agreement with Pfizer, potentially worth up to 60.5billion(approximately435billionRMB)[1]−ThistransactionsetsanewrecordfortheamountofasingleproductgoingoverseasfromaChinesepharmaceuticalcompanyandhighlightsthestrongemergenceofChineseinnovativedrugcompaniesintheglobalbispecificantibodymarket[1]TransactionDetails−TheagreementgrantsPfizertherightstodevelop,produce,andcommercialize3SBio′sself−developedPD−1/VEGFbispecificantibodySSGJ−707inglobalmarketsoutsidemainlandChina[2]−Pfizerwillpayanupfrontfeeof60.5 billion (approximately 435 billion RMB) [1] - This transaction sets a new record for the amount of a single product going overseas from a Chinese pharmaceutical company and highlights the strong emergence of Chinese innovative drug companies in the global bispecific antibody market [1] Transaction Details - The agreement grants Pfizer the rights to develop, produce, and commercialize 3SBio's self-developed PD-1/VEGF bispecific antibody SSGJ-707 in global markets outside mainland China [2] - Pfizer will pay an upfront fee of 12.5 billion (approximately 90 billion RMB) and up to 4.8billioninmilestonepayments,alongwithadouble−digitpercentagetieredrevenuesharefromsalesinthelicensedregions[2]−Allpaymentsarenon−refundableandnon−offsettable,andPfizerretainstheoptiontocommercializetheproductinmainlandChina[2]ProductAdvantages−SSGJ−707isdevelopedbasedon3SBio′sproprietaryCLF2platform,featuringacommonlightchainsymmetricaldesignandIgG−likestructure,whichsignificantlyreducesproductioncostsandenhancesefficiency[3]−Clinicaldatashowspromisinganti−tumoractivityandsafety:−Objectiveresponserate(ORR)of70.84.8 billion in milestone payments, along with a double-digit percentage tiered revenue share from sales in the licensed regions [2] - All payments are non-refundable and non-offsettable, and Pfizer retains the option to commercialize the product in mainland China [2] Product Advantages - SSGJ-707 is developed based on 3SBio's proprietary CLF2 platform, featuring a common light chain symmetrical design and IgG-like structure, which significantly reduces production costs and enhances efficiency [3] - Clinical data shows promising anti-tumor activity and safety: - Objective response rate (ORR) of 70.8% and disease control rate (DCR) of 100% for PD-L1 positive non-small cell lung cancer (NSCLC) [3] - ORR of 81.3% for squamous NSCLC and 58.3% for non-squamous NSCLC, with DCR at 100% when combined with chemotherapy [3] - Adverse event rates for grade 3 or higher treatment-related adverse events (TRAE) range from 8.9% to 23.5%, significantly lower than similar products [3] Market Outlook - The PD-1/VEGF bispecific antibody market is expected to explode, with Evaluate Pharma predicting a global market size exceeding 80 billion by 2030 [5] - Currently, only Kangfang Biotech's Ivosidenib is on the market, and 3SBio's rapid advancement positions it to seize market opportunities [5] Industry Trends - The total value of License out transactions for Chinese innovative drugs reached 51.9billionin2024,ayear−on−yearincreaseof27.451.9 billion in 2024, a year-on-year increase of 27.4%, accounting for 30% of global similar transactions [6] - In the first quarter of 2025, Chinese companies completed 41 overseas transactions totaling over 36.9 billion, with a growing proportion of "heavyweight transactions" [6] - This collaboration further confirms the transition of Chinese innovative drug companies from "followers" to "leaders" in the global market [6] Industry Outlook - This transaction not only brings substantial cash flow to 3SBio but also highlights the maturity of Chinese pharmaceutical companies in target selection, clinical design, and international collaboration [7] - As more original Chinese drugs enter the global market, the "two-way rush" between multinational and Chinese pharmaceutical companies may become the new norm, accelerating the gathering of global pharmaceutical innovation resources in China [7] Conclusion - The collaboration between 3SBio and Pfizer marks a significant milestone for Chinese innovative drugs going global, transitioning from "Made in China" to "Created in China" [8] - With support from policies, capital, and technological breakthroughs, Chinese pharmaceutical companies are entering a golden era of License out, potentially reshaping the global pharmaceutical market landscape [8]