每经记者｜金喆 每经编辑｜张海妮 5月30日，美国生物技术公司Summit Therapeutics（SMMT.US）宣布了依沃西单抗全球Ⅲ期临床试验 HARMONi研究的顶线结果。 该临床试验有两个主要终点，分别是无进展生存期（PFS）和总生存期(OS)。此前其他临床研究已经显 示了依沃西单抗的PFS数据优于同类药物，市场都在等待OS数据的揭晓。 结果显示，相比单纯化疗，依沃西单抗联合化疗在PFS这一主要终点上取得统计学显著且具临床意义的 改善，风险比为0.52（95% CI：0.41–0.66；p<0.00001）；在OS上显示出积极趋势，但未达到统计学显 著获益，风险比为0.79（95% CI：0.62–1.01；p=0.057）。 Summit表示，尽管另一项主要终点——总生存期（OS）未达到统计学显著差异，但数据显示出积极趋 势。公司将利用HARMONi试验的数据，向美国食品药品监督管理局提交生物制剂许可申请。 《每日经济新闻》记者注意到，这一结果与康方生物在中国开展的HARMONi-A试验结果一致。美股市 场对这一数据反应强烈，5月30日，Summit股价大跌。 依沃西单抗是一款PD-1/VEGF ...

智通财经APP获悉，美国生物技术公司Summit Therapeutics(SMMT.US)周五宣布，其与中国合作伙伴康 方生物合作开发的主要资产ivonescimab在肺癌联合治疗方案的临床试验中达成了主要目标。 Summit援引3期HARMONi试验的顶线数据称，这款PD-1/VEGF双特异性抗体与化疗联用，在无进展生 存期(PFS)这一主要终点上达到了统计学显著且具有临床意义的改善。此外，该公司表示，尽管另一项 主要终点——总生存期(OS)未达到统计学显著差异，但数据显示出积极趋势。 据悉，这项全球性试验旨在评估ivonescimab联合化疗与安慰剂联合化疗在局部晚期或转移性非鳞状非 小细胞肺癌患者中的疗效，这些患者的肿瘤携带表皮生长因子受体(EGFR)突变。这类患者对第三代 EGFR酪氨酸激酶抑制剂治疗无效。而在这一治疗设定中，已知的抗PD-1单克隆抗体在全球3期临床试 验中未能在PFS或OS方面取得成功。 关于耐受性，Summit表示，HARMONi试验未显示出新的安全性信号，在接受ivonescimab+化疗治疗的 患者中约有57%出现了3级或以上的治疗相关不良事件，而对照组中该比例约为50%。 ...

Core Points - The Shanghai Composite Index increased by 0.38%, while the China Hong Kong US Listed China-US Technology Index reported 4940.78 points [1] - The China Hong Kong US Listed China-US Technology Index has risen by 13.75% in the past month, decreased by 3.63% in the past three months, and increased by 9.97% year-to-date [1] - The index is composed of liquid and high market capitalization securities from the technology sector listed in Hong Kong and the US, calculated using equal-weighted methodology [1] Index Holdings - The top ten holdings of the index include BYD Company (3.34%), Xiaomi Group-W (3.19%), SMIC (2.91%), Innovent Biologics (2.56%), Alibaba (2.53%), Netflix Inc (2.47%), Avago Technologies Ltd (2.45%), Tencent Music (2.41%), CanSino Biologics (2.37%), and WuXi Biologics (2.36%) [1] - The index's market segment distribution shows that the Nasdaq Global Select Market accounts for 42.03%, Hong Kong Stock Exchange for 34.61%, New York Stock Exchange for 21.69%, and Nasdaq Capital Market for 1.66% [2] Industry Composition - The industry composition of the index indicates that Information Technology comprises 40.08%, Consumer Discretionary 21.52%, Communication Services 14.25%, and Healthcare 13.89% [2] - The index samples are adjusted biannually, with adjustments occurring on the next trading day after the second Friday of June and December [2]

Group 1: Market Overview - The Hang Seng Index closed at 23,345 points, with investors considering the index's strength if it holds between 22,800 and 23,000 points. The past three days showed a volatility of 3%, making it challenging for derivative investors due to the lack of clear direction. The index is in a balanced state from April 23 to 30, with no significant change in the upward trend, although technical signals are not as strong as before. The support level is at 22,400 points, and the resistance level is at 23,800 points [1]. Group 2: Company Analysis - NetEase (09999) closed at 190 HKD, with strong buying signals indicated by 18 buy signals and only 2 sell signals. The stock has broken through the upper band of the Bollinger Bands, with the next resistance level at 213.9 HKD [3]. - Alibaba (09988) closed at 123.4 HKD, showing a weaker performance with a significant drop. However, it has not yet breached the middle line of the Bollinger Bands at 118.9 HKD. The support level is at 115 HKD, with a total of 14 buy signals and 6 sell signals, leaning towards a bullish outlook [5]. - China Mobile (00941) closed at 85.8 HKD, with a positive trend as it broke through the daily chart's top. The closing price is just above the top, indicating further upward potential. The resistance levels are at 87.5 HKD and 87 HKD [8]. - CanSino Biologics (9926) closed at 83.5 HKD, having fallen from 105 HKD. The stock remains below the Bollinger Bands, with 9 sell signals despite a primary buy signal. Key support levels are at 73.4 HKD and 75.8 HKD [11]. - Meituan (03690) closed at 131.4 HKD, with concerns about maintaining the 130 HKD level. The stock is on a downward trend, with support levels at 124.5 HKD and 126 HKD [14].

Core Viewpoint - The article emphasizes the importance of small and medium-sized enterprises (SMEs) in driving innovation in China, highlighting the role of specialized and innovative SMEs as leaders in this sector [1]. Group 1: Specialized and Innovative SMEs - Approximately 99% of enterprises in China are SMEs, with over 140,000 specialized and innovative SMEs cultivated, including more than 14,600 "little giant" enterprises [1]. - A meeting was held by the State Council Information Office featuring representatives from specialized and innovative SMEs to discuss their role in strengthening advanced manufacturing [1]. Group 2: Case Study - Guangdong Zhongshan Kangfang Biopharmaceutical Co., Ltd. - Summer Meng, a senior director at Guangdong Zhongshan Kangfang Biopharmaceutical Co., has been involved in clinical drug development for 12 years, focusing on confirming the efficacy and safety of new drugs [3]. - The company has developed 11 monoclonal antibody drugs, with over 16,000 patients participating in clinical trials, providing advanced treatment options for late-stage cancer patients [3]. - Four clinical projects managed by Summer Meng have been launched, including innovative drugs for gastric and cervical cancer, which have shown good clinical results and reduced medical costs [3]. Group 3: Policy Support and Industry Growth - The Guangdong government has identified biopharmaceuticals and health as one of its ten strategic pillar industries, implementing various supportive policies [4]. - In 2024, the biopharmaceutical and health industry cluster in Guangdong is expected to achieve approximately 448.66 billion yuan in revenue, with the pharmaceutical manufacturing sector generating 196.25 billion yuan [5]. - The government aims for the biopharmaceutical and health industry cluster to exceed one trillion yuan by 2027, with the scale of regulated pharmaceutical industry exceeding 500 billion yuan [5].

Core Viewpoint - The China-Hong Kong-US Technology Index has shown a recent increase of 16.93% over the past month, indicating a positive trend in the technology sector despite a slight decline of 2.72% over the last three months and a year-to-date increase of 4.73% [1] Group 1: Index Performance - The China-Hong Kong-US Technology Index opened at 4705.23 points [1] - The index is calculated using an equal-weighted methodology, reflecting the overall performance of high liquidity and high market capitalization technology companies listed in China and the US [1] Group 2: Index Holdings - The top ten holdings of the index include: SMIC (3.35%), Xiaomi Group-W (3.23%), BYD Company (3.13%), Innovent Biologics (2.67%), Alibaba (2.66%), Netflix Inc (2.52%), CanSino Biologics (2.52%), Tencent Holdings (2.33%), China Biologic Products (2.30%), and Avago Technologies Ltd (2.28%) [1] - The index is composed of companies from various exchanges, with the Nasdaq Global Select Market accounting for 40.80%, Hong Kong Stock Exchange for 35.55%, New York Stock Exchange for 22.12%, and Nasdaq Capital Market for 1.53% [2] Group 3: Sector Allocation - The sector allocation of the index shows that Information Technology comprises 39.80%, Consumer Discretionary 20.93%, Healthcare 14.20%, and Communication Services 14.16% [2] - The index samples are adjusted biannually, with adjustments occurring on the next trading day after the second Friday of June and December [2]

Core Viewpoint - The recent developments surrounding Innovent Biologics' core product, Ivosidenib, have generated significant market interest, particularly following its positive clinical trial results against the leading PD-1 inhibitor, Keytruda [2][3]. Group 1: Clinical Trial Results - Ivosidenib's new indication for non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA) in China, based on the HARMONi-2 clinical trial data [2][5]. - The HARMONi-2 trial demonstrated a median progression-free survival (PFS) of 11.14 months for Ivosidenib compared to 5.82 months for Keytruda, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [5][9]. - The overall survival (OS) analysis showed an HR of 0.777, suggesting a 22.3% reduction in the risk of death, which is close to the FDA's threshold for approval [5][6][7]. Group 2: Market Reactions - Following the announcement of the OS data, shares of Summit, Ivosidenib's overseas partner, fell nearly 36%, while Innovent's stock dropped by 11% [3]. - The market's reaction reflects concerns over the OS data's adequacy for U.S. approval, despite the positive PFS results [3][7]. Group 3: Regulatory Insights - The FDA requires that for OS to be a primary endpoint in clinical trials, the HR must be less than 0.8 for approval, which Ivosidenib's data nearly meets [6][9]. - Innovent's strategy involved designing the HARMONi-2 trial with PFS as the primary endpoint, aligning with regulatory expectations while still aiming for OS data to support future approvals [8][9]. Group 4: Industry Impact - The results from the HARMONi-2 trial are seen as a significant milestone in the field of cancer immunotherapy, potentially reshaping treatment standards for NSCLC [11][12]. - The ongoing HARMONi-7 trial aims to further validate Ivosidenib's efficacy in a larger patient population, with plans to enroll nearly 800 patients [13].

Core Viewpoint - 康方生物's new indication for依沃西单抗 has been approved by the National Medical Products Administration (NMPA) for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC), based on positive results from the HARMONi-2 clinical trial [1][2]. Group 1: Clinical Trial Results - In the HARMONi-2 trial, the median progression-free survival (PFS) for the依沃西 group was 11.14 months, compared to 5.82 months for the帕博利珠 group, with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [2]. - The interim analysis for overall survival (OS) showed a HR of 0.777, reflecting a 22.3% reduction in the risk of death for the依沃西 group compared to the帕博利珠 group [2]. Group 2: Market Reaction - Despite the positive clinical data,康方生物's stock fell over 19% on April 28, closing at 87.20 HKD per share, while its partner Summit's stock dropped more than 36% [3]. - Market sentiment suggests that while依沃西 shows clinical benefits compared to帕博利珠, it did not achieve the statistical significance expected by investors, as帕博利珠 has shown greater risk reductions in OS in previous trials [3]. Group 3: Company Perspective - 康方生物's CEO,夏瑜, stated that the market's interpretation of the data is somewhat misaligned, emphasizing that OS was not the primary endpoint of the study and that the low maturity of the OS data (39%) was intended to show a trend of benefit [3][4]. - The company designed the HARMONi-2 trial to focus on PFS as the primary endpoint, with the aim of obtaining approval for the first-line NSCLC indication in China [4].

Innovation and Product Development - Akeso, Inc. has developed over 50 innovative projects in various fields, including oncology, autoimmune, and metabolic diseases, with 71 products approved for market and 1 product under NMPA review[10]. - The company has 12 products in Phase III clinical trials and 12 products in Phase I/II clinical trials, with 15 potential first-in-class or best-in-class bispecific/multispecific antibodies[10]. - The company aims to become a leading global biopharmaceutical enterprise by focusing on innovative R&D, establishing a world-class production system, and continuously expanding its commercial network[10]. - Three new products were approved for market launch, and two new indications were approved for existing products[20]. - A total of 24 products are undergoing global clinical research, with over 25 registration/Phase III clinical studies conducted[20]. - The company has submitted new indication applications for five products, indicating ongoing innovation[20]. - The approval of the self-developed drugs Inusimab (PCSK9) and Yiruoqi (the first self-developed IL-12/IL-23 in China) marks the official launch of the company's non-oncology specialty drug business[21]. - The company is building an international leading advantage in tumor immunotherapy with over 40 indications explored through clinical therapy and Phase III clinical studies[21]. - The company is focused on global market expansion and innovative drug development, enhancing its long-term growth foundation[20]. - The company continues to strengthen its global development momentum through source innovation[20]. - The company aims to continue developing new drugs and integrating global resources, focusing on the global development and commercialization of Kadooni and Yiwosi[24]. - The company is strategically advancing Yidafang in various cancers, with ongoing Phase III trials for colorectal cancer and pancreatic cancer initiated[45]. - The company has multiple IND-stage projects in development, indicating a robust pipeline for future growth[105]. Financial Performance - The total revenue for the year ending December 31, 2024, was RMB 2,123.9 million, a decrease of 53.08% compared to RMB 4,526.3 million for the year ending December 31, 2023[25]. - The commercial sales revenue after deducting distribution costs was RMB 2,002.4 million, an increase of 24.88% from RMB 1,603.5 million in 2023, driven by the continued growth of Kadooni (卡度尼利) and the positive sales contribution from Yiwosi (依沃西) after its approval in May 2024[28]. - The gross profit for the year ending December 31, 2024, was RMB 1,834.9 million, a decrease of 58.23% from RMB 4,393.0 million in the previous year[26]. - The company recorded a loss of RMB 501.1 million for the year ending December 31, 2024, compared to a profit of RMB 1,942.4 million for the year ending December 31, 2023[27]. - The company's research and development expenses for the year ending December 31, 2024, were RMB 1,187.7 million, a decrease of 5.29% from RMB 1,254.0 million in the previous year, due to enhanced internal clinical team capabilities[85]. - The sales and marketing expenses for the year ending December 31, 2024, were RMB 1,001.8 million, reflecting a 12.51% increase from RMB 890.4 million in the previous year, driven by accelerated commercialization efforts[87]. - The financial cost for the year ending December 31, 2024, was RMB 68.3 million, a decrease of 21.53% from RMB 87.0 million in the previous year, primarily due to lower borrowing rates[89]. - The company has short-term and long-term loans totaling RMB 3,941.6 million, with RMB 535.5 million due within the next year[91]. - As of December 31, 2024, the company's current assets totaled RMB 8,691.6 million, with cash and cash equivalents amounting to RMB 7,343.9 million, an increase of RMB 2,449.4 million from RMB 4,894.4 million as of December 31, 2023[90]. Clinical Trials and Approvals - Kadooni has received approval for second-line treatment of cervical cancer and has initiated 28 clinical trials across 20 indications, including gastric, lung, and liver cancers[29]. - Yiwosi has shown significant positive results in three Phase III clinical trials, establishing its clinical and commercial value in the NSCLC field[23]. - Kadooni's sNDA for first-line treatment of unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma was approved in September 2024[31]. - The company is advancing over 12 Phase III clinical trials and more than 20 Phase II clinical trials for Yiwosi globally, positioning itself as a leader in the market[23]. - The company is advancing multiple Phase III clinical trials for Cardunili, focusing on major indications such as lung cancer and gastric cancer, with ongoing patient enrollment[36][37]. - The AK117 (CD47) trial for head and neck squamous cell carcinoma is the first Phase III registration trial for a CD47 product in solid tumors, with data presented at the 2024 ESMO[48]. - The Phase III trial (AK112-303/HARMONi-2) for Yidafang against Pembrolizumab in treating PD-L1 positive NSCLC achieved positive results, with data presented at the 2024 WCLC[42]. Market Strategy and Expansion - The commercial development journey will begin in 2025, focusing on the hospital market[21]. - The company is committed to upgrading its commercial system to seize opportunities in the rapidly changing Chinese innovative drug industry[73]. - The company has a strategic focus on expanding its oncology and immunology product lines, with substantial investment in clinical trials[108]. - The company aims to leverage its cornerstone drugs, Kadcyla® and Ivosidenib, to cover a broader market space through extensive combination therapies[64]. - The company has established an exclusive sales agreement for monoclonal antibodies with a projected annual cap of RMB 3,000 million for sales and promotion fees by December 31, 2024, and RMB 6,000 million for sales of monoclonal products[150]. Workforce and Operations - The total number of employees as of December 31, 2024, is 3,035, an increase from 2,778 in 2023, reflecting a growth of approximately 9.3%[70]. - The workforce in clinical research has increased to 700 from 679, showing a focus on enhancing research capabilities[70]. - The production, quality assurance, and quality control department has expanded to 814 employees, up from 687, indicating growth in operational support[70]. - The sales and marketing team has grown to 816 employees, an increase from 788, reflecting an emphasis on market expansion[70]. - The company has maintained stable employee relations without any significant strikes or labor disputes affecting business activities[142]. Governance and Compliance - The company is committed to compliance with relevant laws and regulations, with no significant violations reported for the year ending December 31, 2024[141]. - The company has implemented internal controls to ensure compliance with listing rules regarding related party transactions[157]. - The board of directors includes Dr. Xia Yu as the Chairman, President, and CEO, and Dr. Li Baiyong as the Executive Vice President and Chief Scientific Officer[137]. - The company has undergone changes in its board composition, with several appointments and resignations effective June 30, 2024[137]. - The company has a dedicated company secretary with over 17 years of experience in providing corporate services[134]. Financial Commitments and Investments - The company completed the acquisition of a 35% stake in 康融東方 for RMB 267.4 million on February 8, 2024, making it a wholly-owned subsidiary[95]. - The company's capital commitments as of December 31, 2024, were RMB 734.0 million, down from RMB 770.0 million a year earlier, primarily due to ongoing construction of production facilities[98]. - The net proceeds from the 2024 March placement were utilized according to previously disclosed intentions, ensuring transparency in fund allocation[106]. - The company plans to accelerate clinical trials for multiple products, including PD-1/CTLA-4 and CD47, with significant funding allocated for these initiatives[105]. Community Engagement and Corporate Responsibility - The group made charitable donations of approximately RMB 41.8 million during the year, an increase from RMB 23.6 million in 2023[179]. - The company is committed to environmental sustainability and adheres to relevant environmental protection laws and regulations[140]. - The company has a strong focus on resource efficiency, waste reduction, and energy savings in its operations[140].

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926 HK) with a target price of HKD 115, indicating a potential upside of 16.3% from the current price of HKD 98.90 [7]. Core Insights - 康方生物's application for the PD-L1 positive NSCLC indication for its drug 依沃西 has been approved in mainland China earlier than expected, just 9 months after submission [1]. - The initial overall survival (OS) interim analysis from the HARMONi-2 study shows a hazard ratio (HR) of 0.777, indicating a 22.3% reduction in the risk of death, although it has not yet reached statistical significance [1]. - The report expresses optimism regarding the overseas development of 依沃西, particularly the ongoing HARMONi-7 study, which is expected to have a higher probability of achieving significant results due to a larger sample size and a focus on patients with higher PD-L1 expression [1]. Summary by Sections Approval and Clinical Data - The approval of 依沃西 for PD-L1 positive NSCLC in mainland China reflects regulatory confidence in the clinical benefits observed [1]. - The interim analysis of the HARMONi-2 study is based on a sample size of 398, with a low alpha allocation value of 0.0001, suggesting that the results may improve as more data matures [1][2]. Market Potential - The report forecasts peak sales of 61 billion RMB in mainland China and 5.7 billion USD overseas for 依沃西, highlighting its significant commercial potential [1]. - The upcoming data readout from the global Phase III HARMONi study for 2L EGFR+ NSCLC is anticipated to be a key event for investors [1]. Pipeline Developments - The report notes that the first clinical-stage antibody-drug conjugate (ADC) targeting HER3 has commenced enrollment in Australia, and a second ADC targeting TROP-2/Nectin-4 has received FDA clinical approval [1].