本报讯 （记者王镜茹）12月30日晚，百奥泰生物制药股份有限公司（以下简称"百奥泰"）发布公告称，公司已于近日收到 合作伙伴Sandoz AG（以下简称"Sandoz"）支付的450万美元里程碑付款。此笔款项源于双方此前就BAT1706（贝伐珠单抗）注 射液签署的授权许可与商业化协议。 公告显示，该笔450万美元里程碑付款的到账，进一步充实了公司的现金储备，将为后续管线研发及国际化战略的推进提 供资金支持。 回溯此前合作，百奥泰于2021年9月8日与Sandoz达成协议，将BAT1706在美国、欧洲、加拿大及大部分其他未覆盖国际市 场的排他性产品商业化权益有偿许可给Sandoz。 根据当时签署的协议条款，该项合作的首付款及里程碑款总金额最高可达1.55亿美元，其中包括2750万美元的首付款、累 计不超过1.275亿美元的里程碑付款，以及两位数百分比的利润分成。 （编辑 张伟） ...

Core Insights - The transaction involves the sale of the Just - Evotec Biologics manufacturing site in Toulouse for approximately US$ 350 million in cash, along with upfront technology license fees for Evotec's continuous manufacturing platform [1] - Evotec is eligible for additional license fees and development revenues, including success-based milestones, which could exceed US$ 300 million in the coming years [1] - The agreement covers royalties on a portfolio of up to ten biosimilars, targeting over US$ 90 billion in originator net sales, enhancing Evotec's revenue mix and profit margins [1] Financial Impact - The sale is immediately earnings accretive, improving Evotec's short, mid, and long-term revenue mix and capital efficiency [1] - Total potential payments from the transaction may exceed US$ 650 million, in addition to royalties from up to ten biosimilar molecules, six of which have an originator net sales value of US$ 90 billion [1] Transaction Details - The agreement was finalized following a non-binding term-sheet in July and a contract signing in November, with the effective date of the transaction being December 5, 2025 [1] - The buyer of the Toulouse site is Sandoz AG, which will benefit from Evotec's continuous manufacturing platform technology [1]

Core Insights - Company announced the completion of the first patient dosing in a Phase 1 clinical trial for HLX13, a biosimilar of ipilimumab, for the treatment of unresectable hepatocellular carcinoma (HCC) in China [1] - The trial is a multicenter, randomized, double-blind, parallel-controlled study aimed at evaluating the pharmacokinetics, safety, efficacy, and immunogenicity of HLX13 compared to the original drug YERVOY® in previously untreated advanced HCC patients [1][2] - HLX13 is also being developed for multiple indications including melanoma, renal cell carcinoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The global sales of ipilimumab are projected to be approximately $2.873 billion in 2024 [3] Group 1 - HLX13 is a biosimilar of ipilimumab, designed to enhance immune response by blocking CTLA-4, thereby targeting tumors [2] - The Phase 1 trial involves a 1:1 random allocation of participants to receive either HLX13 or YERVOY® combined with OPDIVO® treatment [1] - The primary endpoint of the trial is the area under the concentration-time curve (AUC) from dosing to 21 days post-administration [1] Group 2 - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023 [2] - The company has entered into a licensing agreement with Sandoz AG for the commercialization of HLX13 in the U.S. and select European regions, Japan, Australia, and Canada [2] - The sales figure for ipilimumab indicates a significant market potential for HLX13 as a biosimilar in the oncology sector [3]

Core Insights - EirGenix Inc. has entered into a second global exclusive licensing agreement with Sandoz AG for the commercialization of its breast cancer biosimilar EG1206A, covering all territories except specific Asian markets [1][2] - The agreement includes up to USD 152 million in upfront and milestone payments, along with profit sharing and sales incentives post-launch [1][2] - EG1206A has received positive feedback from the U.S. FDA and EMA, allowing for an abbreviated development pathway without Phase III trials [2] Company Developments - EirGenix has successfully developed multiple biosimilar products using reverse engineering technologies, enhancing its global competitiveness [5] - The company is accelerating the development of four HER2-targeted antibody programs and expanding its product pipeline and CDMO services [5] - EirGenix's production capacity and facilities have attracted attention from international pharmaceutical companies, indicating strong growth potential [5] Market Context - There are approximately 2.3 million breast cancer patients globally, with 20% diagnosed with HER2-positive disease, indicating a significant market for EG1206A [3] - The combination therapy of Trastuzumab and Pertuzumab is the current standard of care, with potential market expansion for EG1206A as new treatment options emerge [3] - Roche's Perjeta® generated global sales of approximately USD 4 billion in 2024, highlighting the lucrative market for HER2-targeted therapies [3][4] Strategic Partnership - The partnership with Sandoz strengthens the existing collaboration, following a previous agreement for EG12014, which is already approved in Europe and under review in the U.S. [2] - Sandoz is a leader in affordable medicines, with a portfolio of around 1,300 products and net sales of USD 10.4 billion in 2024 [4]

Core Viewpoint - Company plans to adjust the development strategy of BAT3306 (a biosimilar of Pembrolizumab) and terminate the ongoing BAT3306-002 study, with future decisions pending careful evaluation [1][2][3] Development Strategy Adjustment - BAT3306 is currently involved in a Phase I/III study (BAT3306-002) assessing its pharmacokinetics, efficacy, and safety in combination with chemotherapy for stage IV non-small cell lung cancer [2] - The adjustment in development strategy is influenced by recent communications from the FDA and EMA, indicating a reduced necessity for comparative efficacy studies for biosimilars in the approval process [2][3] - Two other companies developing Pembrolizumab biosimilars have also halted their Phase III efficacy studies, opting for submissions based on Phase I and analytical data [2] Financial Implications - The total investment in the BAT3306 project has reached 224 million yuan, with all R&D expenses accounted for in the respective accounting periods, indicating no substantial impact on current or future financial performance [4] - The company has incurred cumulative losses exceeding 1.8 billion yuan since its listing, with only one profitable year in 2021 due to licensing income [5] Revenue and R&D Expenditure - Revenue figures from 2020 to 2024 show fluctuations, with revenues of 185 million yuan, 837 million yuan, 456 million yuan, 705 million yuan, and 743 million yuan respectively, while net profits remained negative [6] - R&D expenses have consistently exceeded revenue, with ratios of R&D expenditure to revenue ranging from 304% to 104.7% over the same period [6] Market Context - Pembrolizumab (Keytruda) is a leading PD-1 inhibitor with over 30 approved indications and sales reaching 25.011 billion USD in 2023, with its key patent expiring in 2028, potentially opening a significant market for biosimilars [4] - The company will continue to monitor regulatory developments and evaluate the future of the BAT3306 project based on the latest policy dynamics [4] Competitive Risks - The company faces risks from centralized procurement policies, as three of its four approved products are biosimilars, which are a major source of revenue [7]

Core Viewpoint - Fosun Pharma reported a decline in revenue but an increase in net profit for Q1 2025, attributed to asset sales and financial asset valuation changes [1][2]. Financial Performance - The company achieved operating revenue of 9.42 billion yuan, a year-on-year decrease of 7.26% [1]. - Net profit attributable to shareholders was 765 million yuan, a year-on-year increase of 25.42 [1]. - The non-recurring net profit was 410 million yuan, a year-on-year decrease of 32.56% [1]. - Net cash flow from operating activities was 1.056 billion yuan, a year-on-year increase of 15.08% [1]. Strategic Developments - Fosun Pharma is actively exiting and integrating non-core assets to optimize its asset structure and accelerate cash flow [2]. - The company received approvals for two innovative drugs during the reporting period: Hetronifly in the EU and a phosphate absorption inhibitor in China [2]. - Fosun Pharma strengthened global licensing collaborations, including agreements with Dr. Reddy's and Sandoz AG for commercialization rights in various regions [2]. Management Changes - The company announced a restructuring of its board, with key leadership changes including Chen Yuqing becoming the new chairman and executive director [3]. - The new leadership will focus on strategic development and talent management [3].

Core Viewpoint - The company has entered into a collaboration and licensing agreement with Sandoz AG for the development, production, and commercialization of its investigational product HLX13 in specified regions [1] Group 1: Agreement Details - The agreement grants Sandoz AG rights to develop, produce, and commercialize HLX13 in the United States, 42 European countries, Japan, Australia, and Canada [1] - Sandoz AG will pay up to $191 million to the company, which includes an upfront payment of $31 million and milestone payments related to development [1]