康方生物 (9926 HK) 1 年股价表现 7/23 11/23 3/24 7/24 -30% -20% -10% 0% 10% 20% 30%9926 HK 恒生指数 资料来源: FactSet 专家解读:看好依沃西海外成功率,安全性或成关键优势;重申买入 个股评级 买入 医药 2024 年 7 月 4 日 收盘价 目标价 潜在涨幅 港元 36.50 港元 70.00 +91.8% | 股份资料 | | |------------------------|-----------| | 52 周高位 (港元 ) | 51.95 | | 52 周低位 (港元) | 31.25 | | 市值 ( 百万港元 ) | 31,508.63 | | 日均成交量 (百万) | 5.14 | | 年初至今变化 (%) | (21.34) | | 200 天平均价 (港元 ) | 44.40 | | | | 财务数据一览 | 年结 12月31 日 | 2022 | 2023 | 2024E | 2025E | 2026E | |--------------------------------|----------|----- ...

港股通 决胜肺癌,依沃西单抗带来新曙光 | 华泰研究 | 深度研究 | 投资评级(维持 ): | 买入 | |---------------------------------------|--------------|---------------------|--------| | 2024 年 6 月 26 日│中国香港 | 生物医药 | 目标价 (港币): | 60.54 | 依沃西单抗获得两大临床阳性结果,维持公司"买入"评级 近日,公司连续披露两项 PD-1/VEGFR 双抗依沃西单抗的 III 期临床结果, 在 PD-L1 TPS ≥ 1%的 NSCLC 患者中头对头击败帕博利珠单抗(全球首个 在 III 期临床单药头对头胜出的 PD-1 抗体)、和在 EGFR-TKI 耐药 NSCLC 患者中取得 PFS 7.1 vs 4.8 月的显著获益。依沃西单抗于 5 月 24 日在国内 获批上市,我们预计其国内峰值销售额 71 亿元。我们预计 2024/2025/2026 年公司营收为 25.72/42.20/62.93 亿元,归母净利润为(3.60)/3.77/10.30 亿 元,对应 EPS (0 ...

Investment Rating - The report assigns a "Buy" rating for the company, with a target market price of HKD 35.5 and a total valuation of HKD 377 billion [3][4]. Core Insights - The company is positioned as a leading player in the dual antibody market, with significant advancements in internationalization and product commercialization, particularly with its innovative therapies targeting various cancers [5][6]. - The company has successfully launched multiple products, including AK105, AK104, and AK112, and is actively pursuing global market opportunities, especially for AK112 [5][6]. - The report highlights the company's strong growth trajectory, with projected revenues of CNY 24.73 billion, CNY 37.43 billion, and CNY 55.81 billion for 2024, 2025, and 2026, respectively [6]. Summary by Sections Company Overview - The company, established in 2012, focuses on developing innovative antibody drugs for major diseases, including cancer and autoimmune disorders. It has launched several products in the domestic market and is expanding its pipeline into non-cancer areas [13][14]. Product Pipeline - AK105 is the first commercialized product, approved for multiple indications, including first-line NSCLC and relapsed cervical cancer. The company has established partnerships for its overseas sales [22][25]. - AK104 is the world's first PD-1/CTLA-4 dual-specific antibody, recently approved for treating recurrent cervical cancer, with ongoing studies for additional indications [28][30]. - AK112 targets non-small cell lung cancer (NSCLC) and has received approval for its first indication, with further studies underway to expand its application [5][6]. Financial Projections - The company anticipates significant revenue growth driven by its product launches and international collaborations, with a total valuation of HKD 377 billion based on a segmented valuation approach [6][4].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 70.00, indicating a potential upside of 59.1% from the current price of HKD 44.00 [1][2]. Core Insights - The company has achieved positive results in its Phase III clinical trial (AK112-303/HARMONi2) against Keytruda for PD-L1 positive NSCLC, demonstrating a significant improvement in progression-free survival (PFS) [1][2]. - AK112 is the first drug to show survival benefit improvement in a head-to-head Phase III trial against a PD-1 monotherapy, with expected hazard ratio (HR) below 0.7 [1][2]. - The company plans to submit a supplemental application for new indications to the National Medical Products Administration soon [1]. Summary by Sections Clinical Trial Results - The HARMONi-A study reported a median PFS of 7.1 months for the treatment group (AK112 + chemotherapy) compared to 4.8 months for the control group, with an HR of 0.46 (P<0.001) [5]. - Subgroup analyses showed significant PFS benefits across various patient populations, including those with brain metastases and specific mutations [7][9]. Financial Projections - Revenue is projected to grow from RMB 838 million in 2022 to RMB 4,526 million in 2023, with a subsequent decline to RMB 3,097 million in 2024, followed by recovery in the following years [12]. - The net profit is expected to turn positive in 2023, reaching RMB 2,220 million, before experiencing fluctuations in the following years [12]. Market Position - The company is positioned as a leading player in the biopharmaceutical sector, with a market capitalization of HKD 37,983 million and a significant trading volume [3][11]. - The report highlights the company's strong potential in the global market, particularly in the oncology segment, following the successful trial results [2][5].

Summary of Conference Call Company and Industry - The conference call pertains to ZTE Corporation, specifically focusing on its pharmaceutical division and the clinical trial results of its drug AK12 [1] Core Points and Arguments - The company announced that AK12, a first-line head-to-head competitor to K drug, has achieved excellent results in its Phase III clinical trials [1] - Key metrics highlighted include improvements in Progression-Free Survival (PFS) and Health-Related Quality of Life (HFV) [1] Other Important but Possibly Overlooked Content - The success of AK12 in clinical trials may position the company favorably in the competitive pharmaceutical market, potentially leading to increased market share and revenue growth [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 63, indicating a potential upside of 43% from the current price of HKD 44 [4][5]. Core Insights - The interim analysis of the AK112 head-to-head trial against Keytruda (K drug) for the treatment of 1L PD-L1+ NSCLC has shown positive results, aligning with expectations and driving a significant rebound in the company's stock price [2][3]. - The specific interim analysis data from the HARMONi-2 trial is expected to be presented at the WCLC 2024 conference in September, which could further influence market sentiment [3]. - The success of the HARMONi-2 trial is anticipated to accelerate the company's ongoing trials and open up new potential combination therapies, although the commercial potential in the 1L NSCLC market remains to be clarified by the results of the HARMONi-3 trial [3]. Financial Projections - Revenue is projected to grow significantly from RMB 838 million in 2022 to RMB 6,200 million by 2026, with a notable increase of 440.3% in 2023 [7][8]. - The company is expected to return to profitability with a net profit of RMB 1,501 million by 2026, following a loss of RMB 1,168 million in 2022 [7][8]. - The price-to-sales (PS) ratio is forecasted to decrease from 35.1 in 2022 to 5.0 by 2026, indicating improved valuation metrics as the company scales [7][8].

证券研究报告 | 2024年06月02日 康方生物（09926.HK） 优于大市 AK112 头对头 K 药达到优效，有望成为免疫治疗新基石  公司研究·海外公司快评  医药生物·生物制品  投资评级：优于大市（维持） 证券分析师： 张佳博 021-60375487 zhangjiabo@guosen.com.cn 执证编码：S0980523050001 证券分析师： 陈益凌 021-60933167 chenyiling@guosen.com.cn 执证编码：S0980519010002 证券分析师： 陈曦炳 0755-81982939 chenxibing@guosen.com.cn 执证编码：S0980521120001 事项： 康方生物的核心产品PD-1xVEGF双抗依沃西（AK112）在近期取得了一系列重要的研发和监管进展： 1）AK112获得中国药监局批准上市，适应症为联合化疗治疗EGFR-TKI进展的EGFRm nsqNSCLC； 2）AK112在ASCO年会上披露联合化疗治疗EGFR-TKI进展的EGFRm nsqNSCLC的3期临床数据； 3）AK112头对头帕博利珠单抗一线治疗PD- ...

Investment Rating - The report maintains an "Accumulate" rating for the company [1][3]. Core Insights - The company is entering a harvest period as its R&D pipeline accelerates, with revenue forecasts for 2024-2026 raised to 28.96 billion, 45.25 billion, and 63.86 billion RMB, respectively [3]. - The drug Ivoris has shown positive results in head-to-head trials against Keytruda (K drug) for PD-L1 positive patients, marking a significant advancement in treatment options [3]. - Ivoris has recently received approval from NMPA for its first indication, and multiple core indications are progressing [3]. - The company is actively developing its pipeline with several monoclonal antibodies and ADCs in various stages of clinical trials [3]. Summary by Sections Investment Rating - The company is rated "Accumulate" based on its strong market performance expectations [1][3]. Revenue Forecast - Revenue projections for 2024, 2025, and 2026 have been adjusted to 28.96 billion, 45.25 billion, and 63.86 billion RMB, respectively, indicating a positive growth outlook [3]. Clinical Development - Ivoris has outperformed K drug in a Phase III trial, achieving significant improvements in overall response rate (ORR) and progression-free survival (PFS) [3]. - The company has initiated several Phase III clinical trials for Ivoris in various lung cancer indications, with expected completion of enrollment in the second half of 2024 [3]. Pipeline and Long-term Growth - The company is advancing multiple monoclonal antibodies and ADCs, with several candidates in NDA and Phase III stages, ensuring a robust pipeline for future growth [3].

Summary of the Conference Call for 康方生物 (Kangfang Biologics) Company Overview - 康方生物 is a biopharmaceutical company focused on developing innovative therapies, particularly in oncology. The company recently achieved significant milestones in its clinical trials. Key Points and Arguments Clinical Trial Success - 康方生物 announced positive results from the Phase III clinical trial of its drug 伊沃西单抗 (H112), which is a head-to-head comparison with 帕布利珠单抗 (Pembrolizumab) for the treatment of PDL1 positive non-small cell lung cancer (NSCLC) [7][10]. - The trial enrolled 398 patients, and the independent data monitoring committee (IDMC) confirmed that the results were significantly better than expected, particularly in terms of progression-free survival (PFS) [8][10][11]. - The risk ratio for the treatment was reported to be significantly favorable, indicating a strong clinical benefit [10][11]. Market Response and Future Plans - Following the announcement of the positive trial results, 康方生物's stock experienced a notable increase, reflecting investor confidence in the drug's potential [14]. - The company plans to submit for new drug approval (NDA) and aims to present detailed data at the World Lung Cancer Conference in September [13][24]. - 康方生物 is also preparing to expand its commercial team to support the launch of its products, with a focus on ensuring effective market penetration [46][48]. Safety and Efficacy - The safety profile of 伊沃西单抗 was emphasized, with the drug designed to minimize adverse effects while maximizing therapeutic efficacy [20][44]. - The company highlighted that the drug's design allows for better accumulation in tumor environments, contributing to its safety and effectiveness [44][45]. Long-term Vision and Strategy - 康方生物 is committed to a long-term strategy in the biopharmaceutical industry, focusing on continuous innovation and development of its product pipeline [35][36]. - The company has a robust research and development team and plans to introduce additional non-oncology products in the near future [33][34]. Industry Context - The conference highlighted the competitive landscape of the oncology market, particularly the advancements in PD-1/PD-L1 therapies. 康方生物 aims to position its products as foundational therapies in cancer treatment [25][26][27]. Investor Communication - 康方生物 maintains a transparent communication policy with investors, ensuring that all research outcomes, regardless of their nature, are shared openly [9][10]. Additional Important Content - The conference included discussions on the implications of the trial results for future collaborations and the potential for accelerated clinical development in partnership with other companies [29][41]. - The management expressed confidence in overcoming market volatility and emphasized the importance of a strong, experienced team in navigating challenges [36][37]. This summary encapsulates the key insights from the conference call, focusing on the company's recent achievements, strategic direction, and commitment to transparency and safety in its product offerings.