新诺威选择在此刻递表，面临的不仅是自身业务的挑战，更是一个日益复杂和挑剔的港股资本市场环 境。其H股发行定价，将直面三重市场现实的拷问。 双重失血？ 新诺威的港股之路，始于一个宏伟蓝图，却陷于现实的泥潭。 起初，作为石药集团旗下的重要资本平台，新诺威被赋予了构建"创新药帝国"的使命，试图从一家功能 性原料(合成咖啡因)生产商，转型为创新药企。其转型路径清晰而大胆：一方面，控股创新药资产平台 巨石生物，布局ADC、mRNA疫苗等前沿领域；另一方面，计划收购控股股东旗下成熟的"现金奶牛"石 药百克，用其稳定利润来反哺创新研发的巨大投入。 然而，这一叙事的关键一环在2025年4月彻底断裂。新诺威终止了对石药百克76亿元的收购。背后的原 因残酷而现实：石药百克的核心产品"津优力"在集采冲击下，价格从约1600元/支骤降至约666元/支，销 量却未实现增长，市场竞争因多款同类长效药物获批而急剧恶化。更重要的是，其被寄予厚望的GLP-1 类减肥药管线，在拥挤的赛道中既无进度优势也无差异化优势，难以填补收入缺口。 失去了外部"供血"，新诺威自身的财务状况迅速恶化，陷入"双重失血"的境地。 一方面，传统的咖啡因业务增长乏力， ...

Core Insights - The article discusses the competitive landscape of the drug Diphenylhydantoin, primarily dominated by CSPC Pharmaceutical Group, and highlights the recent failed market entry attempt by a subsidiary of Fosun Pharma, Jinzhou Aohong Pharmaceutical, with their modified new drug SBK010 [1][11]. Market Overview - Diphenylhydantoin, marketed as Enbip, is a Class 1 new drug in China, providing new hope for patients with ischemic stroke. The soft capsule form was launched in 2004, and the injection form was approved in 2009, making it the third Class 1 new drug with independent intellectual property rights in China after artemisinin and bifendate [3]. - The market for Diphenylhydantoin is substantial, with projected total sales exceeding 6 billion yuan in 2024, and sales nearing 3 billion yuan by mid-2025, accounting for nearly 30% of CSPC's revenue [3][5]. Competitive Challenges - Despite the attractive market prospects, many companies have attempted to enter the Diphenylhydantoin market through generic or modified versions but have ultimately failed [5]. - The primary obstacles for generic versions include the lack of inclusion in the reference preparation directory, which has delayed the approval process for many companies that have completed bioequivalence (BE) trials [8][14]. Clinical Trial Insights - The failure of Fosun's SBK010 is attributed to the absence of Phase III clinical trials, which CSPC has rigorously conducted, establishing a robust clinical trial system that ensures the safety and efficacy of Diphenylhydantoin [11][14]. - Currently, only Hebei Saipuruisi Pharmaceutical Technology Co., Ltd. is advancing a Phase III clinical trial for a modified version of Diphenylhydantoin, which could potentially break the current deadlock in the market [14]. Patent Landscape - Although the compound patent for Diphenylhydantoin has expired, CSPC has successfully extended the composition and preparation method patents until 2032, complicating the entry of other companies into the market [14][15]. - The combination of unresolved reference preparation status, unclear clinical pathways, and stringent patent restrictions creates significant barriers for competitors seeking to develop their own versions of Diphenylhydantoin [14]. Innovation and Future Outlook - CSPC continues to innovate, having launched several new drugs in 2024, including Enlansumab and Omab, while also achieving breakthrough therapy designations for multiple projects, reinforcing its leadership in the pharmaceutical market [15].

Group 1: Innovation Drug Development - The company is optimistic about the future of China's innovative drug market, with a record-breaking overseas transaction amount in 2025 [2] - The company has multiple products in critical clinical trial stages and is committed to accelerating innovation pipelines [3] - The company’s R&D investment accounts for 43% of revenue, significantly exceeding industry standards, yet revenue from biopharmaceuticals is only 0.94 billion [5] Group 2: Financial Management and Cash Flow - The company reported a net cash outflow of 1.235 billion, but has 455 million in idle funds for financial management [3] - The company maintains a low-risk investment strategy for idle funds to support R&D and operational activities [3] - The caffeine business has a global market share exceeding 50%, but revenue has declined due to a 20% drop in export prices [5] Group 3: Market Strategy and Competition - The company’s product, Enlansumab, has entered the insurance reimbursement list, with ongoing commercialization efforts [10] - The company faces intense competition in the PD-1 market, with an average annual price drop exceeding 20% [10] - The company is exploring various strategies to maintain gross margins in the face of price drops due to centralized procurement [8] Group 4: Future Plans and Strategic Direction - The company aims to transform into an innovative drug company, leveraging its strong cash flow from functional raw materials to support R&D [5] - The company plans to enhance its core competitiveness in the biopharmaceutical sector and achieve profitability in its innovative drug segment [9] - The company is actively utilizing national policies to promote innovative development [7]

Core Viewpoint - The company is actively involved in the development of SYS6010 and has made significant progress in clinical trials, while also addressing the decline in revenue from its functional raw materials business due to fluctuating caffeine prices [1] Group 1: Product Development - The company currently does not have any GLP-1 related products [1] - The clinical study for SYS6010 targeting EGFR mutation TKI-resistant non-small cell lung cancer has officially started in March this year and is currently enrolling participants [1] - The company is exploring multiple combination therapy studies covering esophageal squamous cell carcinoma, small cell lung cancer, and both EGFR mutant and wild-type non-small cell lung cancer frontline patients [1] - There are no data release plans for H2 this year, with updates expected next year [1] Group 2: Commercialization and Clinical Trials - The company's Enlansumab has been included in the medical insurance, and commercialization is proceeding normally [1] - Key clinical trials for first-line recurrent or metastatic cervical cancer are currently underway [1] - A II/III phase clinical trial for small cell lung cancer post-chemotherapy consolidation treatment is set to begin in June 2025 in China, with the first subject already enrolled [1] - The company is also exploring trials related to the combination of PD-1 and SYS6010 (EGFR-ADC) products [1] Group 3: Revenue and Market Conditions - Revenue from the functional raw materials business has declined primarily due to the drop in caffeine prices compared to the highs of 2022 and 2023 [1] - Currently, caffeine prices have stabilized, and this business segment continues to maintain a high level of profitability [1]

Group 1: Production and Market Strategy - The company has a caffeine production capacity of 16,700 tons/year, with a sales volume of 14,010 tons in 2023. It aims to enhance gross margins through product structure upgrades and explore new application fields such as medical beauty and pet health [1] - The company is committed to maintaining its competitive edge in the functional raw materials industry by expanding into niche products like theobromine and theophylline, leveraging its production advantages to create a diversified profit engine [1] Group 2: Research and Development - The company emphasizes innovation and R&D as core drivers for future growth, focusing on aligning product development with market demand to mitigate the high failure rates and costs associated with drug development [2] - Significant resources are being allocated to accelerate product layout and R&D progress, with a goal to solidify and expand its innovative biopharmaceutical platform [2] Group 3: Financial Performance and Shareholder Information - As of April 10, 2025, the number of shareholders is 10,386 [4] - The company plans to disclose its Q1 2025 report on April 24, 2025, and has already released its 2024 annual report on March 21, 2025 [4] Group 4: Market Impact and Risk Management - The direct revenue from the U.S. market is low, and the current tariff policies have minimal direct impact on the company's profitability, indicating manageable risk [4] - The company is actively monitoring changes in international trade policies to address potential risks [4] Group 5: Product Development and Sales - The company is in the process of commercializing the innovative drugs Enlansumab and Omabuzumab, which have been approved for inclusion in the medical insurance directory [5] - The sales network for these products is being developed systematically [5]