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华丽家族: 华丽家族股份有限公司关于上海证券交易所监管工作函的回复公告

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].