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].

每经记者｜周逸斐 每经编辑｜陈星 她举了一个例子，团队研发的一款用于治疗非小细胞肺癌的双抗新药，这个药物目前已经在一项Ⅲ期关键性临床试验中， 对比国际标准治疗方案，实现疗效接近翻倍，这让团队感到欢欣鼓舞。当这个非常好的疗效数据公布在世界肺癌大会以及 国际期刊上以后，引发了产业界和国际医学界很大反响。 "年轻人不应该只盯着风口" 5月13日，国新办举行"新征程上的奋斗者"中外记者见面会。 党的十八大以来，我国大力推进新型工业化，加快制造业转型升级，涌现出一大批专精特新中小企业，数量已经超过了14 万家。其中，专精特新"小巨人"企业达到14600多家。这些企业都具有专业化、精细化、特色化和创新能力强的特征，在整 个产业中发挥了强链、固链、稳链的重要作用。 当天，来自"小巨人"企业的五位代表走进国新办发布厅，围绕"走专精特新之路 做大做强先进制造业"与记者交流。 通过科技创新研发出疗效更好、安全性更高的药品 专精特新中小企业是以专注、专业、专长见长，一般都在特定领域有自己的"绝活"。 广东中山康方生物医药有限公司临床运营资深总监夏梦莹表示："我们的'绝活'就是通过科技创新研发出疗效更好、安全性 更高的药品。在传统的 ...

Core Viewpoint - The company aims to leverage technological innovation to provide patients with access to groundbreaking disease treatment solutions despite facing significant challenges [1]. Group 1: Company Overview - Guangdong Zhongshan Kangfang Biopharmaceutical Co., Ltd. is focused on the development of innovative drugs, with a commitment to clinical research and drug efficacy [1]. - The company has successfully developed and launched two innovative drugs for the treatment of gastric cancer and non-small cell lung cancer, which have shown excellent clinical efficacy and are included in the national medical insurance catalog [1][2]. Group 2: Drug Development Challenges - The development of innovative drugs is inherently difficult, requiring over $1 billion and more than 10 years from project initiation to market approval [1]. - The team specializes in creating dual-target monoclonal antibodies that can act on two critical disease targets simultaneously, enhancing both efficacy and safety [2]. Group 3: Clinical Trial Success - A dual-target drug developed for non-small cell lung cancer achieved nearly double the efficacy compared to international standard treatment in a Phase III clinical trial, garnering significant attention from the industry and international medical community [2]. - Over 16,000 patients have participated in clinical trials using the drugs developed by the team, with four projects already on the market benefiting a growing number of patients [2].

Core Viewpoint - The recent policy announced by Trump to align U.S. drug prices with the lowest global prices could lead to a significant decrease in prescription drug prices in the U.S., potentially by 30% to 80%, raising concerns among pharmaceutical companies, especially those exporting to the U.S. [1][2] Group 1: Market Performance - As of May 13, 2025, the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Composite Index (930965) rose by 2.42%, with notable increases in stocks such as BeiGene (06160) up 4.15% and Innovent Biologics (01801) up 3.14% [1] - The Hong Kong Pharmaceutical ETF (159718) opened high and increased by 2.04%, with a latest price of 0.70 yuan, and a one-month cumulative increase of 3.32% [1] - The CSI Pharmaceutical and Medical Device Innovation Index (931484) increased by 0.87%, with stocks like East China Pharmaceutical (000963) rising by 2.23% [4] Group 2: Trading Volume and Liquidity - The Hong Kong Pharmaceutical ETF had a turnover of 1.72% during the trading session, with a transaction volume of 4.0999 million yuan, and an average daily transaction volume of 95.7602 million yuan over the past month [1] - The latest scale of the Medical Innovation ETF (516820) reached 1.588 billion yuan [4] Group 3: Index Composition - The top ten weighted stocks in the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Composite Index accounted for 60.54% of the index, including BeiGene (06160) and WuXi Biologics (02269) [5] - The top ten weighted stocks in the CSI Pharmaceutical and Medical Device Innovation Index represented 66.51% of the index, featuring companies like Hengrui Medicine (600276) and WuXi AppTec (603259) [8]

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]

● 本报记者傅苏颖 近期，中国创新药行业利好消息不断，行业景气度提升。日前备受瞩目的美国癌症研究协会(AACR)年 会在芝加哥召开，多家中国创新药企受邀参会。与此同时，信达生物、康方生物等企业相关产品取得阶 段性突破；部分创新药企业一季报和年报数据亮眼，实现显著同比增长。业内人士认为，随着政策支 持、市场认可提升、投融资环境改善以及研发成果逐步显现，创新药板块发展前景广阔。受益于多个积 极因素推动，医药行业有望在2025年继续迎来估值修复。 创新药密集获批 作为全球规模最大的癌症研究会议之一，AACR年会一直是癌症领域最新研究成果的重要展示平台。近 年来，中国创新药在该会议上的影响力持续攀升。据不完全统计，今年有126家中国药企亮相AACR会 议，共发布近300项新药研究结果，其中包括超80项ADC研究、近40项双抗研究和超10项单抗研究，其 他药物类型还有多肽偶联药物、分子胶、细胞疗法、三抗、PROTAC等，展现出中国创新药研发的强大 实力。 4月28日，和誉医药和信达生物在AACR年会上展示多项最新临床前数据的信息和时间表。信达生物以 壁报的形式展示旗下一系列双抗、三抗及双抗体偶联药物(ADC)肿瘤管线的 ...

根据2025年5月2日披露数据，中国电信（00728）、新天绿色能源（00956）、凯盛新能（01108）位居 港股通持股比例前3位，分别为73.85%、67.51%、67.45%。此外，美团-W（03690）、康方生物 （09926）、中银香港（02388）在最近有统计数据的5个交易日内，持股额增幅最大，分别为+26.00亿 元、+5.73亿元、+4.88亿元;腾讯控股（00700）、阿里巴巴－W（09988）、盈富基金（02800）在最近 有统计数据的5个交易日内，持股额减幅最大，分别为-31.32亿元、-23.84亿元、-17.21亿元。 具体数据如下（交易所数据根据T+2日结算）： 1、港股通最新持股比例排行（前20名） | 公司名称 | 持股数量 | 最新持股比例 | | --- | --- | --- | | 中国电信(00728) | 102.49亿股 | 73.85% | | 新天绿色能源(00956) | 12.42亿股 | 67.51% | | 凯盛新能(01108) | 1.69亿股 | 67.45% | | 白云山(00874) | 1.46亿股 | 66.27% | | 绿色动力环保 ...

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].