机构：中金公司 研究员：张琎/杨一正/朱言音 在全球范围内积极开展对外合作。公司已与阿斯利康就CLDN 18.2 ADC（CMG901）达成全球独家授权 协议，阿斯利康已启动CM901 单药治疗2L 及以上晚期或转移性胃及胃食管结合部腺癌的III 期MRCT 研 究，目前入组进度已过半。此外，公司就CM512（TSLPxIL13）、CM536、CM336（BCMAxCD3）、 CM313（CD38）、CM355（CD20xCD3）通过NewCo的形式，快速推进海外临床进度：1）CM313 和 CM355 均于今年1 月份分别于Timberlyne 和Prolium 达成独家授权，1H25 合计确认首付款和近期付款 3.18 亿元，增厚公司收入；2）CM512 正在探索更长给药间隔，其中重度特应性皮炎、慢性鼻窦炎伴鼻 息肉、中重度哮喘、COPD 均处于国内II期临床阶段，Belenos 也启动了哮喘适应症的美国I 期临床，首 例受试者于3 月入组；3）Ouro 获得了CM336 首个海外IND 批准，首例受试者于8 月入组。 盈利预测与估值 由于公司CM313 和CM355 对外授权首付款及近期付款确认增厚，我 ...

Core Insights - The innovative drug market in China is experiencing significant growth, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing share of BD transactions, particularly in the autoimmune disease sector, which is gaining attention due to unmet medical needs [2][23] - The emergence of bispecific antibodies (dual antibodies) in the autoimmune disease field is anticipated to create new blockbuster drugs, as they can target multiple antigens simultaneously, enhancing treatment efficacy [7][8][23] Group 1: Market Dynamics - The market for autoimmune disease treatments is projected to reach $119.35 billion by 2027, driven by high demand and long treatment cycles for conditions like systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) [2] - The TNFα inhibitors, particularly AbbVie's Humira, have generated over $200 billion in revenue over its lifecycle, showcasing the potential for successful drug development in the immune market [2][4] - The competition in the immune drug market is intensifying, with a growing number of patented drugs and a shift towards precision medicine in clinical and commercial strategies [5] Group 2: Bispecific Antibodies - Bispecific antibodies are gaining traction in autoimmune disease treatment, with the ability to simultaneously target different antigens, potentially leading to more effective disease management [7][8] - Clinical data from Roche's bispecific antibody shows significant efficacy in treating refractory SLE patients, indicating the potential of this class of drugs in the autoimmune sector [8] Group 3: Company Insights - Kangnuo Pharmaceutical is positioned as a leading player in the autoimmune field, with its core product CM310 being the first domestically approved IL-4Rα antibody, currently in the commercialization stage [13][23] - The success of CM310 in the market is contingent on its inclusion in the medical insurance negotiation, which is crucial for its sales growth [16][23] - Kangnuo's innovative approach through the NewCo model for licensing out its products has proven beneficial, providing cash flow support and reducing risks for the company [22][23] Group 4: Future Outlook - The potential for Kangnuo's CM310 to achieve significant sales in the Chinese market is optimistic, with projections suggesting it could reach nearly $5 billion by 2030 if it successfully navigates the insurance landscape [23] - The company's advancements in the ADC drug CMG901 for cancer treatment are also noteworthy, with clinical progress ahead of competitors [19][23]

Group 1 - The innovative drug market in China is experiencing a surge, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing proportion of BD transactions. The share of tumor pipeline overseas licensing transactions decreased from 72% in 2023 to 61% in 2024, while the share of metabolic and autoimmune drugs increased from 12% to 25% [1][2] - The autoimmune disease market is gaining attention due to its large unmet medical needs, with the global treatment market projected to reach $119.35 billion by 2027 [2] Group 2 - The immune drug market has evolved since the introduction of TNFα inhibitors, with new targets emerging, including interleukin classes and JAK/Tyk2 inhibitors. The competition in clinical and commercial stages is intensifying, with a focus on precision treatment [5][7] - Bispecific antibody drugs are gaining traction in the treatment of autoimmune diseases, offering the ability to target two different antigens simultaneously, which may lead to more effective disease management [7][8] - The first bispecific antibody drugs in the autoimmune field are expected to create a new wave of growth, with companies like 康诺亚 leading the development [23] Group 3 - 康诺亚's core product, CM310, is the first domestically approved IL-4Rα antibody drug, with significant market potential in treating various allergic diseases. Its success in entering the medical insurance negotiation at the end of the year is crucial for its market performance [13][16] - The company has a strong pipeline in the autoimmune field, with CM310 expected to generate substantial sales, potentially reaching 5 billion yuan by 2030 [23] - 康诺亚 is also advancing in the oncology sector with its ADC drug CMG901, which is in the lead for clinical development among competitors [19][23] Group 4 - 康诺亚 has successfully engaged in multiple NewCo agreements, indicating its potential for international expansion and valuation growth in the innovative drug sector [22] - The NewCo model provides a favorable environment for domestic biotech companies, allowing them to secure cash flow and mitigate risks while advancing their research and clinical trials [22] - The recent licensing deal with GSK, which includes a $500 million upfront payment and up to $12 billion in milestone payments, highlights 康诺亚's strong position in the market [12]