股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[ 康 TIna 方fbole] 生 _T 物itle （] 9926） [评Tab级le_：Inv est] 增持 当前价格（港元）： 35.40 依沃西获批上市，ASCO 展现显著 PFS 获益 2024.05.28 海 ——康方生物公司跟踪点评 [ 交Ta易bl数e_据M arket] 外 丁丹(分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 52周内股价区间（港元） 31.25-51.95 当前股本（百万股） 866 公 0755-23976735 021-38675855 021-38674878 当前市值（百万港元） 30,651 司 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 证书编号 S0880514030001 S0880523080007 S0880123100004 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 依沃西获批上市，ASCO数据展现显著PFS获益趋势， ...

Summary of the Conference Call for 康方生物 (Kangfang Biologics) on May 24, 2024 Industry and Company Overview - The conference call focused on 康方生物, a biopharmaceutical company specializing in innovative therapies, particularly in the oncology sector. Key Points and Arguments EGFR TKI Resistance ASOO Data 1. The overall survival (OS) trend lines presented were distinct and impressive, marking 康方生物 as the only company to achieve positive results in this area [1] 2. The company demonstrated excellent control over brain metastases, with enrolled patients reflecting real-world scenarios [1] 3. 80% of enrolled patients were resistant to third-generation EGFR TKIs, with all subgroup analyses yielding strong results [1] 4. The hazard ratio (HR) reported was the best at 0.46, which is critical data from the Phase III controlled trial. In comparison, 信达's orient-31 had an HR of 0.51, and checkmate (without Bevacizumab) had an HR of 0.75 [1] Future Clinical Development 1. Upcoming results from head-to-head studies with K drugs are expected soon, which will better illustrate the advantages over K drugs. The resistance to third-generation EGFR TKIs is just an initial step, with ongoing trials planned for future indications [1] 2. The company has developed its own ADC platform, with plans to enter IND in Q3. The dual antibodies NECTIN-4 ADC and TROP2 ADC are set to enter IND next year, with a focus on dual antibody combinations as a future goal [1] 3. An innovative product for psoriasis is also expected to enter clinical trials in the second half of the year [1] Commercialization Outlook 1. The commercialization of AK104 is progressing well, indicating a strong commercial platform and positive clinical experiences with low toxicity [1] 2. There is high anticipation among doctors for AK112, with initial prescriptions expected shortly. The product has already been used by 2,000 patients in clinical settings, contributing to a positive reputation among physicians and ensuring effective commercialization [1] Additional Important Content - The company emphasized the robustness of its dual antibody platform and the positive clinical experiences that support its commercialization efforts [1]

Summary of Conference Call Company and Industry Involved - The conference call was organized by CITIC Securities Co., Ltd. to assist a listed company in a whitelist meeting, limited to invited guests [1] Core Points and Arguments - The content of the meeting does not constitute investment advice under any circumstances [1] - Participants are advised to fully understand various investment risks and make investment decisions based on their own situations, bearing the investment risks independently [1] Other Important but Possibly Overlooked Content - The meeting emphasizes the importance of individual responsibility in investment decisions [1]

Summary of Conference Call Company/Industry Involved - The conference call involves 康康生物 (KangKang Biotech) and the 健体研究会 (Health Research Association) [1] Core Points and Arguments - The call was initiated by Dr. Xia from 康康生物, confirming that all participants could hear him [1] - Dr. Xia expressed concern about the audio quality due to the use of a mobile phone during the call [1] Other Important but Possibly Overlooked Content - The introduction of the call indicates a collaborative effort between 康康生物 and the 健体研究会, suggesting a focus on health-related research and potential developments in the biotech sector [1]

大家参加本次会议会议即将开始请稍后感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后 感谢大家参加本次会议会议即将开始请稍后我们跟大总已经在线了还有一个李博应该马上也播录了待会介绍的时候就是大总李博好吗 大家好欢迎参加康方生物进化交流电话会议下面开始布报名字声声明布报完毕后主持人可直接开始发言本次会议为中信剑投证券股份有限公司中信剑投协助上市公司组织的白名单会议仅限受邀嘉宾参会本次会议内容在任何情形下都不构成对会议参加者的投资建议敬请会议参加者充分了解各类投资风险根据自身情况自主做出投资决策并自行承担投资风险 未经中性箭头和演讲嘉宾许可任何机构和个人不得以任何形式将会议内容和相关信息对外公布、转发、转载、传播、复制、编辑、修改等如有上述违法行为中性箭头保留追究相关方法律责任的权利各位好 各位好 我是那个康康生物的夏博士 我想看看你们是不是都能听得到我说话因为我也是在一个就是会议上就是上来拿着手机在打电话我怕你们听不到都能听到吧夏伯春您好我是建筑研究会非常清楚好呀那太 ...

海 外 研 证券研究报告 究 ＃industryId＃ 医药生物 ＃09926 .HK ＃康dy方Com生pa物ny＃ 港股通（沪） dyStockco ＃investSuggestion＃ ＃ 增持 ( in首 ve次 stS） d e＃ ＃title＃ 依沃西单抗上市申请获受理，卡度尼利单抗快速放量 uggesti onChan ＃createTime1＃ ge＃ 2024年 5月 15日 公 投资要点 ＃市场ma数rk据et Data＃ 司 ＃summary＃ 日期 2024/5/14 ⚫ 产品销售收入高速增长，许可费收入助力公司首次财务盈利：2023年，康方 点 收盘价（港元） 49.20 生物实现上市以来的首次年度财务盈利。报告期内总收入达 45.26 亿元人民 评 总股本（百万股） 865.86 币，同比增长440%；净利润高达19.42亿元人民币，实现首次年度盈利。1） 报 流通股本（百万股） 865.86 2023年公司全年商业化业绩再创新高，全年实现产品销售额16.31亿元人民 告 净资产（百万港元） 5,178 币，同比增长达48%。其中，全球首个获批上市的肿瘤免疫双抗开坦尼®（卡 总资产 ...

Pipeline and Clinical Development - Akeso has over 50 innovative projects in the pipeline, covering oncology, autoimmune, and metabolic diseases, with 19 in clinical trials, including 6 potential global first-in-class or best-in-class bispecific antibodies[15] - The company has 3 drugs in the commercialization phase and 8 registration clinical studies reaching primary endpoints in 2023, including the global first-in-class bispecific antibody PD-1/VEGF (Ivonescimab) and PD-1/CTLA-4 (Cadonilimab)[21] - There are 12 ongoing registrational Phase III clinical studies for the two core bispecific antibodies, Ivonescimab and Cadonilimab[22] - Ivonescimab's NDA for advanced lung cancer was submitted and granted priority review, with potential approval expected in 2024[23] - Cadonilimab's NDA for first-line treatment of advanced gastric cancer was accepted in January 2024, showing superior clinical efficacy regardless of PD-L1 expression status[23] - The company has 4 first-in-class/best-in-class bispecific antibodies in clinical development and over 80 combination therapy studies ongoing[23] - AK112 (PD-1/VEGF) reached primary endpoints in Phase III trials for NSCLC, with NDA submitted and accepted for priority review by NMPA in 2023[31] - Global Phase III trials for AK112 in NSCLC, including HARMONi and HARMONi-3, have commenced patient enrollment, accelerating global clinical development[32] - The company has 3 self-developed innovative products commercialized and 3 additional products under NDA review by NMPA[29] - Annike® (penpulimab, PD-1) received NMPA approval in January 2023 for first-line treatment of locally advanced or metastatic squamous NSCLC, and the company submitted an sNDA in December 2023 for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)[33] - The company submitted NDAs for Inusirumab (AK102, PCSK9) in June 2023 for primary hypercholesterolemia and mixed hyperlipidemia, and for Eruxizumab (AK101, IL-12/IL-23) in August 2023 for moderate-to-severe plaque psoriasis[33] - As of December 31, 2023, the company had over 50 innovative projects in its pipeline, with 19 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[34] - The company is conducting clinical trials for multiple products, including Kadunili (PD-1/CTLA-4), Ewuxi (AK112, PD-1/VEGF), and Annike® (penpulimab, PD-1), covering a wide range of indications in solid tumors and hematologic malignancies[35] - The company submitted NDAs for Inusirumab (AK102, PCSK9) in June 2023 and Eruxizumab (AK101, IL-12/IL-23) in August 2023, and is actively preparing for their commercialization[36] - The company is advancing clinical research and exploration for other products, including Gumoximab (AK111, IL-17) and Mandoximab (AK120, IL-4Rα)[36] - The company's clinical development plan includes global experiments, market approvals, registration clinical trials, and breakthrough therapies, with significant progress in tumor immunotherapy and other therapeutic areas[37] - AK105 (PD-1) combined with AK112 and AK104 is being developed for advanced solid tumors[38] - AK104-302 Phase III trial for G/GEJ adenocarcinoma met the primary endpoint of overall survival (OS) in interim analysis[42] - AK104-303 Phase III trial for cervical cancer met the primary endpoint of progression-free survival (PFS) in interim analysis[42] - AK102 (PCSK9) NDA submitted in June 2023 for familial hypercholesterolemia[40] - AK101 (IL-12/IL-23) NDA submitted in August 2023 for moderate to severe plaque psoriasis[40] - AK120 (IL-4Rα) is in Phase II trials for moderate to severe atopic dermatitis[40] - AK104 combined with chemotherapy completed enrollment for Phase III trial in G/GEJ adenocarcinoma in March[41] - AK104 combined with SPH4336 (CDK4/6 inhibitor) is being developed for WDLS/DDLS tumors[41] - AK104 combined with AK117 received NMPA approval for Phase II trial in G/GEJ adenocarcinoma in April[41] - AK104 combined with chemotherapy received NMPA approval for Phase II trial in pancreatic cancer in May[41] - Kadunilizumab's new indication for first-line treatment of G/GEJ adenocarcinoma was accepted by NMPA in January 2024[45] - Ivonescimab (AK112) combined with LM-302 for advanced gastrointestinal tumors entered clinical studies in March 2023[46] - Ivonescimab's Phase III HARMONi trial for EGFR-mutated NSCLC achieved first patient dosing in the US in May 2023[46] - Ivonescimab's Phase III trial for squamous NSCLC completed patient enrollment in August 2023[46] - AK117's Phase II trial for high-risk MDS was approved by FDA in September 2023[49] - AK117's Phase II trial for AML was approved by NMPA in January 2024[51] - AK102's NDA for hypercholesterolemia was accepted by NMPA in June 2023[58] - AK101's Phase III trial for plaque psoriasis met primary endpoints in February 2023[61] - AK111's Phase III trial for plaque psoriasis achieved all efficacy endpoints in December 2023[63] - The company is conducting over 20 clinical trials for its core bispecific antibody product cadonilimab, covering 16 indications including gastric cancer, liver cancer, and lung cancer[70] - AK120 (IL-4Rα) completed Phase II clinical trial enrollment for moderate-to-severe atopic dermatitis in March 2023[65] - The company has four self-developed bispecific antibody products (AK129, AK130, AK131, AK132) in clinical stages, targeting various solid tumors[70] - Production and commercialization preparations are underway for AK102 (PCSK9) and AK101 (IL-12/IL-23) in the non-oncology sector[71] Financial Performance - Total revenue for 2023 reached RMB 4,526.3 million, a 440% increase compared to RMB 837.7 million in 2022[25][28] - Product sales for 2023 amounted to RMB 1,631.1 million, with Kadunili (PD-1/CTLA-4) sales reaching RMB 1,357.8 million, a 149% increase from RMB 546.3 million in 2022[25][28][29] - Technology licensing and collaboration income for 2023 was RMB 2,922.8 million, largely due to the upfront payment from Summit Therapeutics for AK112 (PD-1/VEGF) licensing[25][28] - Gross profit for 2023 was RMB 4,393.0 million, a 491% increase from RMB 743.5 million in 2022, driven by significant growth in technology licensing and collaboration income[26] - The company recorded a net profit of RMB 1,942.4 million in 2023, compared to a net loss of RMB 1,422.2 million in 2022[27][28] - Total product market sales for the year ended December 31, 2023, reached RMB 1,631.1 million, a 48% increase compared to RMB 1,104.4 million in 2022, driven by strong sales of Cadonilimab (PD-1/CTLA-4) and other products[73] - Cadonilimab (PD-1/CTLA-4) sales for 2023 were RMB 1,357.8 million, a 149% increase from RMB 546.3 million in 2022, contributing significantly to the overall growth[74] - Technology licensing and collaboration income surged to RMB 2,922.8 million in 2023, up from RMB 3.9 million in 2022, primarily due to upfront payments from the Summit collaboration for AK112 (PD-1/VEGF)[76] - Gross profit for 2023 was RMB 4,393.0 million, a 491% increase from RMB 743.5 million in 2022, largely driven by the significant rise in technology licensing income[78] - Other income and net gains for 2023 were RMB 454.2 million, a 186% increase from RMB 158.6 million in 2022, mainly due to foreign exchange gains and interest income[80] - R&D expenses for 2023 decreased by 5% to RMB 1,254.0 million from RMB 1,323.1 million in 2022, as the company internalized some clinical services[81] - Sales and marketing expenses increased by 61% to RMB 890.4 million in 2023, up from RMB 552.7 million in 2022, driven by marketing activities for Cadonilimab[83] - The company reported a net profit of RMB 1,942.4 million for 2023, compared to a net loss of RMB 1,422.2 million in 2022[86] - As of December 31, 2023, the company's cash and cash equivalents, fixed deposits, and financial products totaled RMB 4,894.4 million, a significant increase from RMB 2,288.4 million in 2022[87] - Total employee count increased to 2,778 in 2023, up from 2,341 in 2022, with significant growth in clinical (679 vs. 532) and sales & marketing (788 vs. 652) functions[96] - Total employee compensation costs rose to RMB 847.1 million in 2023, up from RMB 624.1 million in 2022, driven by increased headcount[96] - Capital commitments decreased to RMB 770.0 million in 2023 from RMB 981.1 million in 2022, primarily due to progress in production and R&D facilities in Zhongshan and Guangzhou[97] - The company's quick ratio improved significantly to 4.39 in 2023 from 2.0 in 2022, indicating stronger liquidity position[89] - Total assets pledged as collateral amounted to RMB 793.3 million as of December 31, 2023, securing loans and bank credit facilities[89] - The 2021 placement proceeds of HKD 1,171.3 million (RMB 978.1 million) were fully utilized by December 31, 2023, with 40% allocated to commercialization team establishment and talent retention[99] - R&D employee count increased to 320 in preclinical and 679 in clinical functions in 2023, up from 275 and 532 respectively in 2022[96] - Production, quality assurance, and quality control staff grew to 687 in 2023 from 605 in 2022, reflecting capacity expansion efforts[96] - The company maintains no significant foreign exchange risk, with most transactions settled in RMB and partial cash holdings in HKD and USD[95] - No significant contingent liabilities or major investments were reported as of December 31, 2023[91][93] - The net proceeds from the 2022 placement amounted to approximately $73.46 million (HK$576.66 million), with 40% allocated to the marketing and commercialization of Cadonilimab (AK104, PD-1/CTLA-4), totaling HK$230.6 million[101] - 20% of the 2022 placement proceeds (HK$115.3 million) were allocated to accelerate the Phase III clinical trials of Ivonescimab (AK112, PD-1/VEGF), including head-to-head trials with Keytruda for 1L PD-L1(+) NSCLC[101] - 20% of the 2022 placement proceeds (HK$115.3 million) were used to accelerate Phase III clinical trials of Cadonilimab (AK104) for indications such as 1L gastric adenocarcinoma and 1L cervical cancer[101] - 10% of the 2022 placement proceeds (HK$57.7 million) were allocated to accelerate Phase III trials and NDA applications for Inclisiran (AK102, PCSK9) and Ebdarokimab (AK101, IL-12/IL-23), with HK$41 million utilized and HK$16.7 million remaining unused[101] - The remaining unused net proceeds of approximately HK$16.7 million from the 2022 placement are expected to be fully utilized by June 30, 2024, due to recent progress in Phase III trials and NDA applications for Inclisiran and Ebdarokimab[102] - The 2024 placement raised approximately $149.53 million (HK$1,180.5 million) through the issuance of 24.8 million shares at HK$47.68 per share, representing a 6.02% discount to the last closing price before the placement agreement[103] - 65% of the 2024 placement proceeds will be allocated to R&D, including IND-stage preclinical projects, ADC platform development, and global clinical trials for Cadonilimab (AK104) and Leflunomide (AK117, CD47)[103] - 25% of the 2024 placement proceeds will be used for the commercialization of Cadonilimab and Ivonescimab, while 10% will be allocated for general corporate purposes[103] - The company expects to utilize the 2024 placement proceeds by December 31, 2025, based on current market conditions and operational needs[104] - Total revenue for the year ended December 31, 2023, was RMB 4,526.3 million, including total sales from products and license income of RMB 4,553.9 million, minus distribution costs of RMB 27.6 million[148] - Sales from the top five customers accounted for approximately 75.4% of the company's total revenue in 2023, compared to 29.7% in 2022[148] - The largest customer, SUMMIT, accounted for approximately 64.8% of the company's total revenue in 2023, up from 14.1% in 2022[148] - Purchases from the top five suppliers accounted for approximately 26.2% of the company's total purchases in 2023, down from 30.3% in 2022[149] - The largest supplier accounted for approximately 8.1% of the company's total purchases in 2023, down from 11.0% in 2022[149] - The company made charitable donations of approximately RMB 23.6 million in 2023, compared to RMB 11.8 million in 2022[160] - The company's distributable reserves as of December 31, 2023, were RMB 5,143,796,000, compared to RMB 5,169,255,000 in 2022[165] - The company did not declare a final dividend for the year ended December 31, 2023[163] - The company did not issue any debentures during the year ended December 31, 2023[161] - The company did not provide any financial assistance or guarantees to its affiliates during the year ended December 31, 2023[156] - The company's bank loans and other borrowings as of December 31, 2023, are detailed in the financial statements, with no significant seasonal borrowing requirements[166] Technology and Innovation - The company has developed the Tetrabody technology, which addresses three CMC challenges in bispecific antibody development: low expression levels, process development obstacles, and antibody stability and druggability[15] - The company's ACE platform integrates end-to-end drug discovery and development functions, including target validation, antibody discovery and development, CMC process development, and GMP-compliant manufacturing[15] - The company has expanded its R&D into ADC technology, mRNA technology, and cell therapy to maintain long-term global competitive advantage[24] - The company is proactively developing multiple proprietary technology platforms, including ADC, cell therapy, and mRNA, to efficiently advance more candidate molecules to the clinical stage[36] Commercialization and Sales - Akeso has 31 commercialized products and 42 externally licensed products, including AK107 (CTLA-4) licensed to Merck, AK105 (PD-1) licensed to Lepu Biotech, and AK112 (PD-1/VEGF) licensed to SUMMIT[15] - Akeso's key products include Cadonilimab (PD-1/CTLA-4), Penpulimab (PD-1), and Pucotenlimab (PD-1), which is licensed to Lepu Biotech[15] - Cadonilimab achieved sales of RMB 1.36 billion in 2023, with cumulative sales exceeding RMB 1.9 billion within 18 months of launch[21] - Annike® (penpulimab, PD-1) was included in multiple clinical authoritative recommendations and regional惠民保 catalogs in 2023, and the company expanded its indications to accelerate the transformation of clinical applications into commercial value[33] - In April 2023, the company signed a licensing agreement with Specialised Therapeutics Asia Pte Ltd (ST) for the exclusive sales rights of Annike® in Australia, New Zealand, Papua New Guinea, and 11 Southeast Asian countries[33] - The company's subsidiary, Tianqing Kangfang, entered into an exclusive sales agreement with Lianyungang Zhengda Tianqing for the sales of the monoclonal antibody product, with a fixed sales fee rate of no less than 35%[131][133] - The annual cap for sales and promotion services fees payable to Zhengda Tianqing by Tianqing Kangfang is RMB 2,500 million for 2023, with a cap of RMB 5,000 million for the sales of monoclonal antibody products[134] - The actual sales and promotion services fees paid by Tianqing Kangfang to Zhengda Tianqing during the reporting period were RMB 120,000, and the revenue from the sales of monoclonal antibody products was RMB 117.116 million, both within the 2023 annual cap[134] Organizational and Leadership - The company's organizational capabilities in strategic planning, R&D efficiency, and commercialization have been key to its rapid growth over 11 years[24] - The company's board consists of four executive directors, two non-executive directors, and three independent non-executive directors[105] - Dr. Xia Yu holds a Ph.D. in Molecular Biology and Microbiology from Newcastle University, UK, and has extensive experience in cancer immunotherapy research[108] - Dr. Li Baiyong, co-founder and Chief Scientific Officer, has over 24 years of experience in therapeutic biologics, including leadership roles at Pfizer Inc[

股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[康I Tnaf 方bol]e 生_Ti物tle]（ 9926） [评Tab级le_：Inv est] 增持 当前价格（港元）： 46.65 卡度尼利胃癌数据亮眼，全人群获益优势显著 2024.04.09 海 ——康方生物公司跟踪点评 [ 交Ta易bl数e_M据a rket] 外 丁丹(分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 52周内股价区间（港元） 31.25-51.95 当前股本（百万股） 866 公 0755-23976735 021-38675855 021-38674878 当前市值（百万港元） 40,392 司 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 证书编号 S0880514030001 S0880523080007 S0880123100004 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 公司 AACR年会披露卡度尼利一线胃癌数据，展现全人群获益优势，有望 ...

M N 9 Apr 2024 CMB International Global Markets | Equity Research | Company Update Akeso (9926 HK) Promising Ph3 data of cadonilimab in 1L GC  Promising Ph3 data of cadonilimab in 1L GC, especially for patients with Target Price HK$59.61 low PD-L1 expression. The interim Ph3 (NCT05008783) data of (Previous TP HK$59.61) cadonilimab in 1L GC was recently released at the AACR meeting (link). With Up/Downside 27.8% a median follow-up of 18.7 months, cadonilimab + chemo (XELOX) extended Current Price HK$46.65 t ...

证券研究报告 | 2024年03月25日 康方生物（09926.HK） 买入 卡度尼利销售增长强劲，多款产品研发快速推进 核心观点 公司研究·海外公司财报点评 依沃西有望获批上市，期待头对头K药的数据读出。康方生物的潜在FIC双 医药生物·生物制品 抗依沃西的首个适应症（EGFR-TKI进展的nsqNSCLC）的上市申请已在23年 证券分析师：张佳博 证券分析师：陈益凌 8月获得受理，预计将于今年获批上市。在中国，依沃西单药一线治疗PD-L1 021-60375487 021-60933167 zhangjiabo@guosen.com.cnchenyiling@guosen.com.cn 阳性的NSCLC的3期临床（头对头K药）已于23年8月完成患者入组，预 S0980523050001 S0980519010002 计将于24年中读出中期分析结果。另外，依沃西联合化疗一线治疗sqNSCLC 证券分析师：陈曦炳 的3期临床（头对头替雷利珠单抗）正在进行临床入组。在海外，依沃西针 0755-81982939 chenxibing@guosen.com.cn 对三代EGFR-TKI进展的nsqNSCLC适应症（ ...