Company Overview - Yifang Biotechnology (Shanghai) Co., Ltd. is a research-driven biopharmaceutical company based in China, focusing on significant unmet medical needs in oncology, autoimmune diseases, and metabolic disorders [5] - The company has established a comprehensive and differentiated product pipeline, including two commercialized products (BPI-D0316 and D-1553), two core clinical-stage products (D-2570 and D-0502), one clinical-stage candidate (D-0120), and three preclinical candidates (YF087, YF550, and YF057) [5][6] - BPI-D0316, a third-generation EGFR inhibitor, and D-1553, a KRAS G12C inhibitor, have been approved for marketing in China and included in the National Reimbursement Drug List (NRDL) [5][6] Financial Performance - For the fiscal year ending December 31, 2024, the company reported revenues of approximately RMB 168.79 million, with a gross profit of RMB 164.77 million [8][9] - The company recorded a net loss of approximately RMB 240.20 million for the same period [10] - As of September 30, 2025, the company achieved revenues of approximately RMB 30.89 million, with a gross profit of RMB 26.74 million, and a net loss of approximately RMB 181.39 million [8][10] Customer Dependency - The company has a high customer dependency, with revenues from its largest customer accounting for 90.3% and 73.6% of total revenues for the fiscal years ending December 31, 2024, and September 30, 2025, respectively [7] Industry Overview - The global oncology drug market is projected to grow from USD 143.5 billion in 2019 to USD 253.3 billion by 2024, with a compound annual growth rate (CAGR) of 12.0%, and expected to reach USD 702.7 billion by 2035 [12] - The Chinese oncology drug market is expected to grow from USD 26.5 billion in 2019 to USD 35.9 billion by 2024, with a CAGR of 6.3%, and projected to reach USD 145 billion by 2035 [12] - The global targeted oncology drug market is anticipated to grow from USD 85.5 billion in 2019 to USD 154 billion by 2024, with a CAGR of 12.5%, and expected to reach USD 320.5 billion by 2035 [14] - The Chinese targeted oncology drug market is expected to grow from USD 6.2 billion in 2019 to USD 16.6 billion by 2024, with a CAGR of 21.8%, and projected to reach USD 61.6 billion by 2035 [14]

君赛生物向港交所递交上市申请，中信证券为其独家保荐人。君赛生物是一家致力于实体瘤创新细胞疗 法与创新药开发的生物科技企业，专注开发更安全、更有效、更可及、更可负担的免疫细胞疗法。 TIL疗法是一项个性化疗法，其核心优势在于突破性的疗效，劣势在于制备工艺繁琐，临床方案复杂， 导致综合成本过高，可及性较低，限制其广泛应用。为了使高临床价值的TIL疗法惠及更广大患者，公 司实现从生产端到临床端的创新，在维持TIL疗法治癒性机会的前提下，简化生产工艺与临床方案，显 著提升TIL细胞疗法的安全性、可及性和可负担性。 近年来，全球肿瘤药物市场实现了强劲增长。2024年，该市场规模增至2533亿美元，2020年至2024年的 复合年增长率为13.9%。预计到2030年，市场规模将进一步扩大至4525亿美元，2024年至2030年的复合 年增长率为10.2%，到2035年，市场规模将达到7027亿美元，2030年至2035年的复合年增长率为9.2%。 2024年，中国肿瘤药物市场规模达到人民币2582亿元，2020年至2024年的复合年增长率为6.9%。未来 几年，该市场预计将加速增长，到2030年，市场规模将增至人民币52 ...

Core Viewpoint - The company, Huayi Family, is responding to a regulatory inquiry regarding its acquisition of Haihe Pharmaceuticals, which is focused on innovative cancer drugs. The inquiry raises questions about the necessity of the transaction given the financial performance of both companies, particularly the losses incurred by Haihe Pharmaceuticals and the strategic rationale behind the acquisition [1][20]. Group 1: Industry Overview - The oncology drug market is experiencing significant growth, with global cancer incidence rising from 18.52 million in 2019 to 20.78 million in 2023, reflecting a compound annual growth rate (CAGR) of 2.9%. Projections indicate that by 2030, the number of new cancer cases could reach approximately 24.46 million [2]. - In China, the number of new cancer cases is also on the rise, reaching 4.93 million in 2023, with an expected increase to 5.65 million by 2030, representing a CAGR of 2.0% from 2026 to 2030 [3]. - The global oncology drug market grew from $129 billion in 2018 to $223.2 billion in 2023, with a CAGR of 11.6%. The Chinese oncology drug market increased from $19.9 billion to $30.9 billion during the same period, with a CAGR of 9.2% [4]. Group 2: Haihe Pharmaceuticals Overview - Haihe Pharmaceuticals specializes in the research and development of small molecule anti-cancer drugs, with a pipeline that includes over ten research projects. Three products have been commercialized in China and Japan, while five are in clinical research [4][10]. - The company's main products include SCC244 (Gumetinib) and RMX3001 (oral paclitaxel), with SCC244 approved for treating advanced non-small cell lung cancer (NSCLC) with c-Met exon 14 mutations. RMX3001 is the only approved oral paclitaxel product globally, targeting gastric cancer and showing significant patient compliance advantages [5][6][10]. - Haihe's products demonstrate competitive advantages in clinical efficacy, pharmacological characteristics, and safety profiles compared to similar products in the market [5][10]. Group 3: Financial Performance and Strategic Rationale - Haihe Pharmaceuticals reported revenues of CNY 323 million and CNY 76.82 million for 2024 and the first two months of 2025, respectively, but incurred net losses of CNY 209 million and CNY 16.08 million during the same periods [1]. - Huayi Family's main business is real estate development, with revenues of CNY 161 million and CNY 353 million for 2023 and 2024, respectively, and a projected net loss of CNY 12.5 million to CNY 8.35 million for the first half of 2025 [1][14]. - The acquisition of Haihe Pharmaceuticals is seen as a strategic move to diversify Huayi Family's business and tap into the growing biopharmaceutical sector, which is supported by national policies aimed at fostering innovation in drug development [17][20].