Core Viewpoint - The article highlights the significant milestone of the company starting the Phase III registration clinical trial for Ivosidenib in colorectal cancer (CRC), suggesting it could lead to a transformative impact for the company [3]. Group 1: Colorectal Cancer Overview - Colorectal cancer is the third most common cancer globally, following lung and breast cancer, and is the second leading cause of cancer-related deaths [4]. - The classification of colorectal cancer primarily includes microsatellite instability-high (MSI-H/dMMR) and microsatellite stable (MSS/pMMR), with the latter accounting for approximately 90% of cases [4]. - Prior to the advent of immunotherapy, treatment for metastatic colorectal cancer did not significantly differ between MSI-H and MSS patients, primarily involving VEGF inhibitors and chemotherapy [4]. Group 2: Immunotherapy Efficacy - Immunotherapy, particularly PD-1 inhibitors, has shown significant efficacy in treating MSI-H colorectal cancer, with a median overall survival (OS) of 77.5 months compared to 36.7 months for chemotherapy [5]. - For MSS colorectal cancer, PD-1 inhibitors have demonstrated poor efficacy, with many trials failing to show significant benefits [5][10]. - The combination of PD-1 inhibitors with standard treatments has shown some improvement in overall response rates (ORR) and duration of response (DoR), but overall survival did not improve significantly [9][10]. Group 3: AK112's Potential - AK112 represents a promising advancement in the treatment of MSS colorectal cancer by combining PD-1 and VEGF targeting, potentially enhancing efficacy while reducing side effects [12]. - Initial clinical data for AK112 shows an ORR of 81.8% and a promising progression-free survival (PFS) rate, indicating its potential to outperform existing therapies [14][15]. - The market potential for AK112 in MSS colorectal cancer is substantial, with estimates suggesting a market size of 350-400 billion CNY in China alone, driven by high patient numbers and treatment duration [20]. Group 4: Market Analysis - The colorectal cancer market is expected to be comparable to that of non-small cell lung cancer (NSCLC), with a significant patient population and treatment duration [19]. - In China, the estimated market size for MSS colorectal cancer could reach 150 billion CNY if the company captures a 50% market share [20]. - In the U.S. and other developed countries, the market potential for AK112 could exceed 300 billion USD, reflecting a significant opportunity for the company [22].

新京报讯（记者王卡拉）日前在法国巴黎举行的欧洲肺癌大会（ELCC）上，吉林省癌症中心主任程颖 教授公布了度伐利尤单抗（商品名：英飞凡）治疗同步放化疗后疾病无进展的局限期小细胞肺癌在 ADRIATIC三期临床试验中国队列研究数据，数据显示，与安慰剂相比，患者在两个主要研究终点总生 存期（OS）和无进展生存期（PFS）的获益趋势与全球患者一致。 小细胞肺癌是一种高侵袭性的肺癌类型。Ⅰ-Ⅲ期的局限期小细胞肺癌约占小细胞肺癌的30%。尽管局 限期小细胞肺癌患者对初始化疗和放疗有应答，但仍会复发并且进展迅速 。局限期小细胞肺癌患者预 后极差，只有15%-30%的患者在确诊后可活过5年。 基于ADRIATIC的试验结果，度伐利尤单抗已在美国、欧洲和一些其他国家获批。目前，中国、日本及 其他多个国家与地区的监管机构正在进行相关审评。 在全球530例随机受试者中，95例（17.9%）为中国人群。中国队列的数据显示：与安慰剂相比，度伐 利尤单抗可降低死亡风险29%，两组患者的中位OS均未达到；度伐利尤单抗单药治疗和安慰剂治疗的 三年生存率预估分别为63.7%和55.4%；度伐利尤单抗还将疾病进展或死亡风险降低了33%。度伐利尤 ...

Investment Rating - The industry investment rating is "Positive" with expectations of overall returns exceeding the CSI 300 Index by more than 5% in the next six months [15]. Core Insights - The leading CRO company, WuXi AppTec, has shown continuous improvement in performance, with a revenue of 39.241 billion RMB in 2024, reflecting a year-on-year growth of 5.2% after excluding COVID-19 commercialization projects [3]. - The adjusted non-IFRS net profit for WuXi AppTec reached 10.583 billion RMB, with a net profit margin of 27.0%, marking a historical high [3]. - The company anticipates a revenue growth of 10%-15% in 2025, projecting total revenue to reach between 41.5 billion and 43 billion RMB [5]. - The global medical investment market is showing signs of recovery after two years of decline, with 2,291 investment deals completed in 2024, totaling 58.2 billion USD, a slight increase of 1% compared to 2023 [7]. - Despite the positive outlook for global investment, domestic medical health financing in China decreased by 33% in 2024 compared to 2023, with only 7.3 billion USD raised [8]. Summary by Sections Company Performance - WuXi AppTec's revenue and profit have been steadily increasing, with Q4 2024 revenue reaching 11.54 billion RMB, a 45% increase from Q1 [3]. - The company has maintained a strong performance despite challenges, indicating robust strength and trust from overseas clients in Chinese CROs [5]. Market Trends - The biopharmaceutical sector remains the largest category for investment, with oncology drugs being a hot topic in domestic investments [13]. - The global biopharmaceutical financing landscape is dominated by projects related to AI in pharmaceuticals, weight-loss drugs, and immunotherapy, reflecting significant investor interest [13].

As filed with the Securities and Exchange Commission on July 14, 2023. Registration No. 333- 273067 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTEVO THERAPEUTICS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 2834 81-1567056 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Sean M. Donahue Paul Hastings L ...