ADC先锋迈向全球，创新平台大有可为

增持（investSuggestionChange＃首次 ） ＃title＃ADC先锋迈向全球，创新平台大有可为＃ 2023年12月02日 投资要点 summary＃抗体偶联药物（ADC）赛道快速发展，创新空间大，技术平台型公司具有显著优势。ADC与目前的标准疗法相比显示出显著改善治疗窗口的潜力。预计到2030年全球ADC药物市场规模将达到647亿美元，中国ADC药物市场规模将达到662亿元。ADC的创新涉及抗体、毒素、连接子以及偶联技术等，需要丰富的研发经验以及高效的平台能力。公司在ADC开发方面积累了超过十年的经验，搭建了具有全球竞争力的“OptiDC平台”。 携手全球药企巨头默沙东，提升国际化能力，海外市场想象空间大。公司与默沙东已签订三项合作协议，涉及7项ADC资产。此外，默沙东为公司股东，持股比例6.13%，体现了国际大药企对其产品潜力以及ADC平台的认可，默沙东将为公司ADC资产在海外的临床和商业化提供有力支撑。 海外研究 TROP2 ADC瞄准癌症大适应症，公司的SKB264具备全球同类最优潜力。SKB264与DS-1062相比，毒素间质性肺炎毒性极小；与戈沙妥珠单抗相比，不可逆的位点偶联使得血浆稳定性得到了改善。在国内，SBK264末线治疗三阴乳腺癌（TNBC）预计在23H2递交上市申请（NDA），耐药EGFR突变非小细胞肺癌（NSCLC）已进入关键注册临床，HR阳性乳腺癌（BC）预计在23H2进入关键注册临床。此外，预计默沙东将启动多个全球注册临床。 分析师：张忆东海外研究中心总经理zhangyd@xyzq.com.cnSFC：BIS749SAC：S0190510110012 多款产品蓄势待发，与核心资产形成协同与补充。A166（HER2 ADC）已NDA，将完善公司在乳腺癌领域的布局；A167（PD-L1单抗）也已NDA，是公司探究ADC药物联用方案的重要资产。此外，公司的A140（西妥昔单抗生物类似药）以及A400（RET抑制剂）也都处于关键注册临床阶段，十余款临床前以及临床早期产品也在稳步推进中，建立起完整的产品梯队。 盈利预测及投资建议：我们预计2023-2025年收入为14.00 / 8.29 / 10.16亿人民币，2023-2025年归母利润为-1.67 / -8.90 / -4.41亿人民币。采取DCF模型对公司进行绝对估值分析，给予公司估值282.9亿港币（约259亿人民币），首次覆盖，给予“增持”评级。 风险提示：新药研发失败、临床进展不及预期、价格降幅超预期 KELUN-BIOTECH(06990.HK) Outperform The ADC Pioneer Marches Global, (Initiate) Innovation Platform Has Promising Prospects Healthcare 02/12/2023 ＃summary＃The ADCtrack is developing rapidly,with a large space for innovation,andtechnology platform companies have significant advantages.ADCs show the potential tosignificantlyimprove the therapeutic window compared to current standard of caretherapies. It is estimated that by 2030, the global ADC drug market will reach 64.7 billionUS dollars, and the Chinese ADC drug market will reach 66.2 billion yuan. The innovationof ADCs involves antibodies, toxins, linkers, and conjugation technologies, etc., requiringrich R&D experience and efficient platform capabilities. The company has accumulatedmore than ten years of experience in ADC development and built a globally competitiveOptiDC platform. Joining hands with the global pharmaceutical giant Merck, we will enhance ourinternational capabilities and create a huge space for overseas market imagination.The company has signed three cooperation agreements with Merck, involving seven ADCassets, with a total of up to US$11.8 billion in early-stage and milestone payments. Inaddition, Merck holds 6.13% of the shares, reflecting the recognition of its product potentialand ADC platform by major international pharmaceutical companies. The company is oneof the few innovative drug companies in China that has in-depth cooperation with majorinternational pharmaceutical companies. Merck will provide strong support for the clinicaland commercialization of the company's ADC assets overseas. Analyst ZhangYidongzhangyd@xyzq.com.cnSFC:BIS749SAC:S0190510110012 TROP2 ADC targets major cancer indications, and SKB264 has the best potential ofits kind in the world.Compared with DS-1062, SKB264 uses a toxin that causes minimalILD toxicity; compared with gosatuzumab, the irreversible site coupling improves plasmastability. In China, SBK264 is expected to submit an NDA for 3L+ TNBC in 23H2,TKI-resistant NSCLC has entered key clinical trials, and HR+ BC is expected to enter keyclinical trials in 23H2. In addition, international multi-center registration clinical trials arealso expected to be launched by Merck. A variety of products are ready for launch, synergizing and complementing coreassets.A166 (HER2 ADC) has submitted an NDA, which will complete the company'slayout in the field of breast cancer; A167 (PD-L1 monoclonal antibody) has also submittedan NDA, which is an important asset for the company to explore ADC drug combinationsolutions. In addition, the company's A140 and A400 are also in the critical registrationclinical stage, and more than ten pre-clinical and early-stage clinical products are alsoprogressing steadily, establishing a complete product echelon. Profit forecast:It is estimated that the revenue from 2023-2025 will be 1.400 / 0.829 /1.016 billion RMB. According to the DCF absolute valuation method, the company isvalued at $28.29 billion HKD, with a first coverage and a "outperform" rating. Risks:the risk of new drug development failure, the risk of clinical progress not asexpected, and the risk of an unexpected price reduction. 目录 1、科伦博泰：中国ADC先锋迈向全球.................................................................- 5 -1.1、研发与商业化经验丰富，默沙东参股支持................................................ - 6 -1.2、ADC管线具备全球竞争力，产品储备丰富...............................................- 7 -2、ADC研发如火如荼，OptiDC平台优势显著.................................................. - 10 -2.1、ADC改善治疗窗口，市场规模快速增长.................................................- 10 -2.2、ADC持续迭代发展，考验平台创新能力.................................................- 12 -2.3、超过十年研发经验，OptiDC平台拥有巨大潜力.................................... - 13 -3、SKB264：具备全球BIC潜力的TROP2 ADC ................................................ - 15 -3.1、TROP2 ADC市场空间大，SKB264拥有差异化优势.............................- 15 -3.2、乳腺癌：TNBC数据亮眼，向HR+患者拓展...