自2024年下半年以来，TCE（T细胞衔接器，T cell-engager）逐渐成为MNC的BD心头好。诸多重磅TCE交易相继授出，出海盛况丝毫不逊于当年的ADC技 术。 所谓TCE是一种特殊双抗，一端（或两端）连接TAA（肿瘤相关抗原）定位肿瘤细胞，另一端连接T细胞的CD3表位，激活T细胞，发挥T细胞的肿瘤杀伤 作用。相比ADC用细胞毒素杀伤，TCE双抗本质是激活T细胞的免疫疗法，对靶点表达量要求更低、但肿瘤特异性要求更高。 与个性化、定制化的CAR-T疗法相比，"现货"型TCE双抗在便利性、可及性和生产成本上都具备优势。因此，我们看到，TCE双抗正在作为下一代免疫治 疗的核心方向重构肿瘤与自免疾病治疗格局。 这一潜力赛道中，国内药企百花齐放，进入规模化竞争阶段，形成差异化竞争梯队，既有技术平台驱动的管线深耕，也有全球化BD合作的价值释放。 一场技术革新风暴即将到来，谁会从众多参与者中杀出重围？这一过程中又会否诞生中国创新药的新王呢？ 01 TCE为何起风？ 过去的几十年中，治疗性抗体早已成为肿瘤治疗的关键组成部分，显著提高了疗效。如曲妥珠单抗治疗晚期HER2阳性乳腺癌，利妥昔单抗治疗B细胞淋 巴瘤。然而， ...

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **innovative drug industry** in China, highlighting its growth and international recognition, particularly in the context of major academic conferences like ASR and ASCO [1][2][4]. Core Insights and Arguments - **Policy Support**: Since early 2024, favorable policies have been introduced to support the pharmaceutical industry, positively impacting the valuation of innovative drugs [2][3]. - **International Recognition**: The number of Chinese companies and new drugs showcased at the 2025 ASR and ASCO conferences reached record highs, indicating increased international recognition and collaboration opportunities [1][2][4]. - **Medicare Fund Health**: The Medicare fund is operating well, with a healthy surplus rate, which reduces future payment pressures. New innovative drugs entering negotiations from 2018 to 2024 accounted for only 2% of total fund expenditures, suggesting significant growth potential in the market [1][5]. - **Leading Fields**: China holds a leading position in areas such as ADC (Antibody-Drug Conjugates), monoclonal antibodies, bispecific antibodies, and gene therapy, contributing to the establishment of global competitiveness [1][6]. - **Significant Transactions**: Notable transactions in the innovative drug sector include the licensing of TCE bispecific antibodies from Tongren Pharmaceutical to Merck, with an upfront payment of $700 million, reflecting increased recognition from multinational companies [1][7]. Additional Important Content - **Emerging "留扣" Model**: This new transaction model allows Chinese companies to license products or establish small companies overseas to collaborate with foreign funds, alleviating cash flow pressures and potentially leading to profitable sales in the U.S. market [3][8][9]. - **Profitability Expectations**: Companies like Innovent Biologics and BeiGene are expected to achieve profitability by 2025, indicating that the innovative drug sector is entering a profitable cycle, which may attract more investors [3][10]. - **Impact of Business Development (BD)**: BD activities significantly contribute to company performance, as high-quality research outputs gain international recognition, leading to more licensing deals and collaborations with multinational corporations [11]. - **Valuation Methods**: The common methods for evaluating innovative drug companies include RNPV (Risk-Adjusted Net Present Value) and simplified peak sales multiples, which consider various factors such as discount rates and growth rates [12][17]. - **Factors Influencing PS Multiples**: Key factors affecting the PS multiples include profit margins, product launch speeds, success rates of R&D, and discount rates, all of which have shown positive trends in the innovative drug sector [15][16][18]. This summary encapsulates the essential insights and developments within the innovative drug industry as discussed in the conference call records, providing a comprehensive overview of the current landscape and future prospects.

Core Viewpoint - The domestic innovative drug sector is experiencing a resurgence, driven by the business development (BD) model, which allows companies to monetize their research through partnerships with multinational pharmaceutical firms [1][2]. Company Overview - An innovative biotech company, Aimi Biotech, is preparing for an IPO in Hong Kong and has gained attention for its significant BD transactions, accumulating over $2.1 billion in deal value since the end of 2023, ranking second globally in the TCE bispecific antibody market [1][5]. - Aimi Biotech's founder, Wu Chenbing, previously served as the Chief Scientific Officer and R&D President at 3SBio, indicating a strong connection between the two companies and reflecting the evolution of Chinese innovative drug companies from followers to leaders in the industry [1][5]. Financial Position - As of the end of 2024, Aimi Biotech's cash and cash equivalents are sufficient to sustain operations for only 12 months, highlighting the need for additional funding to support ongoing research and commercialization efforts [2][10]. - The company reported a net profit of 47.7 million yuan in 2024, following a loss of 595 million yuan in 2023, primarily due to R&D expenditures and changes in the fair value of preferred shares [9]. Product Pipeline - Aimi Biotech's lead product, EMB-01, is a bispecific antibody targeting EGFR/cMET, which is expected to enter Phase II clinical trials for metastatic colorectal cancer in the second half of 2025. The global bispecific antibody market is projected to reach $22 billion by 2034, with a compound annual growth rate of 32.4% [8][9]. - The company is also developing other bispecific antibodies, including EMB-06 and EMB-07, which are in various stages of clinical research [9]. Strategic Partnerships - Aimi Biotech has engaged in multiple licensing agreements, including a significant deal with a Spanish pharmaceutical company, Almirall, and a strategic research collaboration with Candid, which collectively contribute to its revenue and market presence [9].

Group 1 - The Hong Kong innovative drug sector has rebounded rapidly due to a favorable external environment, with the China Securities Hong Kong Innovative Drug Index (931787) experiencing a significant recovery since its low on April 9, 2023 [1][3] - As of April 25, 2023, the index reached a peak of 979.92 points, showing a maximum cumulative increase of 37.43% from its previous low [1] - The overall increase in the Hong Kong innovative drug sector has outperformed the Hang Seng Technology Index, which has only seen a year-to-date increase of 12.48% compared to the innovative drug index's 31.03% [3] Group 2 - Recent data indicates a collective performance improvement among Hong Kong innovative drug companies, significantly exceeding market expectations [4] - In 2024, 10 out of 12 Hong Kong innovative drug companies with a market capitalization over 10 billion HKD reported positive revenue growth, with 8 companies also showing positive profit growth [4] - The company with the highest revenue growth is CloudTop New Drug-B (01952), with a revenue growth rate of 341.8%, while Innovent Biologics (01801) reported a net profit growth of 91.8% [4] Group 3 - The trend of "going global" has become a key topic, with Chinese pharmaceutical companies achieving significant growth in overseas licensing transactions [6][8] - The total transaction amount for licensing-out by Chinese pharmaceutical companies reached a historical high of 51.9 billion USD in 2024, indicating a strong global competitiveness in innovative drug development [6] - The NewCo model has emerged as a favorable strategy for domestic biotech companies, allowing for cash flow support and risk sharing in international collaborations [8] Group 4 - New industry trends in pharmaceuticals, such as weight-loss drugs, dual-antibody drugs, ADC drugs, and innovative medical devices, are expected to create new investment opportunities [9] - The Chinese government is increasing support for innovative drug exports, as evidenced by recent policies aimed at facilitating the import of research materials for biopharmaceutical companies [9] - Despite market fluctuations due to trade tensions, the pharmaceutical sector remains relatively insulated, presenting a favorable opportunity for large-scale investments [9] Group 5 - The Hong Kong innovative drug sector is poised for a valuation recovery, with significant inflows of capital from southbound investors since the beginning of the year [11] - As of April 24, 2023, net capital inflows from A-share investors into Hong Kong stocks reached 611.1 billion HKD, with healthcare becoming the second most net inflow sector [11] - The current price-to-earnings ratio (TTM) for the pharmaceutical and biotechnology sector is 27.1, indicating that the sector is undervalued compared to other growth sectors [12][13]