01 中国创新药全球化进程 迈入新阶段 近年来，中国创新药产业正经历从"跟跑"到"并跑"乃至"领跑"的历史性跨越。随着国内生物医药研发能力 的系统性提升，以及全球医药产业链分工的深化调整，中国创新药企业的对外授权交易（Business Development，简称BD）已成为衡量产业国际竞争力的核心指标之一。2025年至2026年初，这一趋势呈现 出明显的加速态势，交易规模屡创新高，交易结构持续优化，标志着中国创新药出海已从早期的单一产品 授权向平台化、体系化合作演进。 从产业逻辑来看，BD交易的密集落地并非偶然现象。一方面，国内创新药企业在抗体药物偶联物 （ADC）、双特异性抗体、小分子靶向药物等前沿领域已建立起差异化的技术平台优势，研发效率与成本 控制能力的国际比较优势日益凸显；另一方面，全球大型制药企业面临专利悬崖压力与研发回报率下降的 双重挑战，对中国创新资产的配置需求显著增强。这种供需两侧的深度耦合，构成了当前BD市场高热运行 的基本面支撑。 撰文：Pharmadeep 编辑：维他命 PART. PART. 02 近期二级市场表现 与BD交易特征分析 2026年1月，医药生物板块整体跑赢沪深300指 ...

Core Viewpoint - The Chinese innovative pharmaceutical sector is entering a golden development period, presenting a once-in-a-century investment opportunity due to unmet global medical needs and significant advancements in the industry [4][9]. Group 1: Market Growth and Trends - In 2025, the total value of out-licensing (BD) transactions for Chinese innovative drugs reached $135.7 billion, a significant increase from $51.9 billion in 2024, with upfront payments rising to $7 billion from $4.1 billion [4][9]. - In January 2026 alone, the transaction volume reached $30 billion, with upfront payments of $3 billion, indicating a strong start to the year [4][9]. - The proportion of external procurement pipelines from China for multinational pharmaceutical companies surged from 10% in 2020 to 42% in 2025, highlighting China's growing importance in the global pharmaceutical landscape [4][9]. Group 2: Clinical Milestones and Innovations - 2026 is identified as a critical year for validating major drugs, with several key clinical milestones expected to emerge, potentially leading to a re-evaluation of industry value [5][9]. - Notable clinical trials include Kangfang Biotech's AK112 for non-small cell lung cancer, which is anticipated to redefine first-line treatment standards [5][9]. - The ADC sector is also poised for significant developments, with Kelong Botai's SKB264 and Baili Tianheng's BL-B01D1 expected to release important phase III clinical data [5][9]. Group 3: Impact on Related Industries - The CXO (Contract Research Organization) sector, closely tied to innovative pharmaceuticals, is expected to benefit from the technological advancements in drug development, leading to a recovery in industry sentiment [5][10]. - Companies within the "WuXi" ecosystem, such as WuXi Biologics and WuXi AppTec, are experiencing a resurgence in orders and performance, reaching historical highs despite previous unfavorable U.S. policies [10].

Summary of Conference Call Notes Industry Overview - The conference call primarily focuses on the pharmaceutical industry, specifically highlighting key players such as Merck and Takeda. Key Points from Merck - Merck emphasizes the continuity of its product pipeline, with SKB264 identified as a next-generation core product [1] - The report highlights the performance focus, aiming for multiple blockbuster products to be launched, which is expected to completely offset the patent cliff of Keytruda (K drug) [1] - SKB264 is anticipated to have several overseas Phase III clinical trial data disclosures starting in 2027, with CNPV expected to significantly accelerate the commercialization approval process [1] Key Points from Takeda - Takeda introduces several core products: - Oveporexton (TAK-861) for Type 1 Narcolepsy (NT1) is expected to receive approval in H2 2026 [1] - Rusfertide (TAK-121) for Polycythemia Vera (PV) is also projected to be approved in H2 2026 [1] - Zasocitinib (TAK-279) for psoriasis is anticipated to gain approval in H1 2027 [1] Additional Important Information - The information presented is a summary of publicly available data from JPM and does not constitute specific investment advice [1]

Core Insights - The biopharmaceutical industry is at a pivotal moment as it transitions from the "14th Five-Year Plan" to the "15th Five-Year Plan," emphasizing the balance between technological innovation and value-driven growth [1] - The recent surge in the innovative drug sector, with the Shanghai Composite Index achieving a 14-day winning streak and the Hong Kong innovative drug index rising by an average of 12% over three days, indicates strong market support for innovative pharmaceuticals [4] - The Chinese government has reinforced its commitment to the innovative drug sector through policies like "Full Chain Support for Innovative Drug Development," which is expected to create significant industry opportunities [4] Industry Growth Drivers - Innovative drugs are recognized as a critical new productive force, comparable in priority to AI and other emerging technologies, with substantial government backing [4] - In 2025, China signed over 150 new business development (BD) agreements in the innovative drug sector, totaling more than $130 billion, a 150% increase from 2024, with upfront payments reaching $7 billion [5] - The anticipated "milestone" rewards from these agreements could exceed $30 billion in the next 3-5 years, fostering the growth of China's innovative drug market despite inherent development risks [5] Market Dynamics - The global biopharmaceutical development landscape is revitalizing due to expiring drug patents and a favorable interest rate environment, with major pharmaceutical companies increasing their R&D investments [6] - The emergence of blockbuster innovative drugs in China, such as AK112 and SKB264, showcases the potential for significant sales in the global market, with some products challenging established leaders [6][7] - The international geopolitical climate is expected to enhance China's economic prospects, leading to increased capital inflows into A-shares and Hong Kong stocks, signaling the onset of a major bull market [7] Future Outlook - The period between 2026 and 2027 is anticipated to yield significant clinical breakthroughs in innovative drugs, potentially leading to substantial stock price revaluations [7] - The next 20 years are projected to be a prosperous era for China, with substantial returns expected for those following technological innovations in the biopharmaceutical sector [8]

Summary of Key Points from the Conference Call Industry Overview - The biopharmaceutical industry is experiencing significant growth, particularly in the CXO and chemical pharmaceutical sectors, with a notable increase in fund concentration in these areas [1][2] - The demand in the diagnostic and treatment sectors remains stable, and the medical insurance fund balance has significantly improved, indicating effective cost control measures [2][5] - The release of the first commercial insurance innovative drug directory in December 2025 has introduced new payment increments for the pharmaceutical industry [2][5] Financial Performance - In the first three quarters of 2025, the license-out transaction amount reached $92 billion, more than doubling year-on-year, indicating strong international recognition of domestic innovative drugs [2][6] - The IPO market in Hong Kong has rebounded, leading to increased investment activity in the primary market, with multiple pharmaceutical companies going public [2][6] Key Focus Areas for 2026 - The industry is expected to focus on innovative therapies, particularly IO (immune-oncology) bispecific antibodies and GLP-1 (glucagon-like peptide-1) drugs [1][4] - Notable advancements in the IO bispecific antibody field include the rapid development of Kangfang Biotech's PD-1/VEGF bispecific antibody AK112, with several key clinical data updates anticipated in 2026 [1][4][8] - Emerging technologies such as small nucleic acids and in vivo CAR-T are expected to show initial progress [4] GLP-1 Drug Market - The GLP-1 drug market shows immense potential, with Semaglutide leading in sales and Tirzepatide expected to become a new "blockbuster" [3][13] - There is a focus on new directions such as oral long-acting formulations and weight loss/muscle gain applications, with new targets like Amylin being explored [3][13][14] Investment Opportunities - The trend of innovative drugs going overseas is beneficial for industry chain enterprises, including major players like WuXi AppTec and WuXi Biologics, as well as CRO companies like InnoStar and Mediso [3][16] - The life sciences sector, including companies like BPS and Haoyuan, is also worth attention due to strong demand and performance certainty [16] Future Trends - The combination of IO and ADC (antibody-drug conjugates) is seen as a necessary direction for future development, with several companies already initiating clinical trials in this area [10][12] - The dual antibody drugs in the colorectal cancer field are becoming important assets for global pharmaceutical companies, indicating strong competitive potential for domestic products [9] Conclusion - The biopharmaceutical industry is poised for growth driven by innovation, with significant opportunities in both domestic and international markets. The focus on emerging technologies and the successful launch of innovative drugs will likely shape the industry's future landscape [1][4][16]

Investment Rating - The report maintains an "Outperform" rating for the industry [2]. Core Insights - The third-generation EGFR TKI has become the first-line standard therapy for advanced EGFR mutation NSCLC, significantly extending median progression-free survival (mPFS) to 18.9-22.1 months compared to earlier generations [4][24]. - The domestic EGFR TKI market is expected to exceed 20 billion CNY in 2024, with third-generation EGFR TKIs accounting for 88% of the market share [4][30]. - There is an urgent need to address resistance mechanisms following third-generation EGFR TKI treatment, with ongoing exploration of fourth-generation TKIs, bispecific antibodies, and antibody-drug conjugates (ADCs) [5][32]. Summary by Sections 1. High Incidence of Lung Cancer in China - Lung cancer is the most common malignant tumor globally, with approximately 2.6 million new cases expected in 2024, including about 1.15 million in China [8]. - Non-small cell lung cancer (NSCLC) accounts for around 85% of lung cancer cases, with adenocarcinoma and squamous cell carcinoma being the most prevalent subtypes [8]. 2. Third-Generation EGFR TKI as First-Line Therapy - The third-generation EGFR TKI has established itself as the first-line treatment for advanced EGFR mutation NSCLC, with significant improvements in mPFS compared to first and second generations [4][16][24]. - The report highlights the efficacy of third-generation TKIs in overcoming common mutations and their favorable safety profile [4][24]. 3. Exploration of Resistance Mechanisms - The report discusses the complexity of resistance mechanisms to third-generation EGFR TKIs, including both EGFR-dependent and independent pathways [5][32]. - Current research focuses on developing fourth-generation TKIs targeting specific mutations and exploring combination therapies with bispecific antibodies and ADCs [5][32][39]. 4. Investment Recommendations - The report emphasizes the growth potential of third-generation EGFR TKIs and suggests monitoring companies like Hansoh Pharma and Eli Lilly for market penetration and sales growth [51]. - It also highlights the progress of ADCs and bispecific antibodies in clinical trials, indicating a robust pipeline for future treatments [51][52].

Core Viewpoint - Kelong Pharmaceutical is a leading enterprise in the domestic large infusion industry, with strong R&D capabilities and a full industry chain advantage [1] Group 1: Business Performance - As of Q3 2025, Kelong Pharmaceutical reported revenue of 13.277 billion, ranking 5th in the industry, exceeding the industry average by 2.8 billion and the median by 0.838 billion, but lower than the top two competitors [2] - The net profit for the same period was 1.245 billion, ranking 9th in the industry, above the industry average of 299 million and the median of 78.29 million, but below the top two competitors [2] Group 2: Financial Ratios - Kelong Pharmaceutical's debt-to-asset ratio was 28.63% in Q3 2025, down from 31.68% year-on-year and below the industry average of 35.26%, indicating good solvency [3] - The gross profit margin for the same period was 47.89%, down from 52.51% year-on-year and below the industry average of 57.17%, suggesting a need for improvement in profitability [3] Group 3: Executive Compensation - Chairman Liu Gexin's salary decreased from 6.9 million in 2023 to 5.6 million in 2024, a reduction of 1.3 million [4] - General Manager Liu Sicong's salary remained stable at 4.8 million in 2024 [4] Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 8.35% to 37,100, while the average number of shares held per shareholder decreased by 7.70% [5] Group 5: Future Outlook - Kelong Pharmaceutical's H1 2025 performance showed a decline, with revenue of 9.083 billion, down 23.2% year-on-year, and net profit of 1.001 billion, down 44.41% [6] - The company expects revenues for 2025-2027 to be 17.886 billion, 20.569 billion, and 22.626 billion, with respective year-on-year changes of -18.0%, +15.0%, and +10.0% [6] - Net profits for the same period are projected to be 2.022 billion, 2.801 billion, and 3.204 billion, with year-on-year changes of -31.1%, +38.5%, and +14.4% [6] Group 6: Innovation and R&D - Kelong Pharmaceutical's innovative drugs are showing rapid sales growth, with the newly approved product contributing to sales [6] - The company has over 30 items in its innovative R&D pipeline, primarily focused on cancer treatment [6][7]

Core Viewpoint - Kolon Biotech Inc. (06990) shares rose nearly 5%, currently up 3.42% at 436 HKD, with a trading volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference held in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 indicated that it surpassed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Core Viewpoint - Keren Biotechnology-B (06990) has seen a stock increase of nearly 5%, currently trading at 436 HKD with a transaction volume of 88.67 million HKD, following the announcement of multiple clinical research results at the ESMO conference in Berlin from October 17 to 21, 2025 [1] Group 1: Clinical Research Results - The company's core product SKB264 was selected for two oral presentations at ESMO, demonstrating BIC potential in the treatment of EGFRm NSCLC in the 2L+ setting, with good safety profile; the indication was approved for market in October [1] - SKB264 showed significantly better results than chemotherapy for HR+/HER2- BC in the 2L+ treatment, with expectations for approval in 2026 [1] - Clinical data for the core product A166 was announced, showing that it outperformed T-DM1 in the treatment of HER2+ BC in the 2L+ setting, with this indication also approved for market in October [1]

Group 1: Market Performance and Opportunities - The MSCI China Healthcare Index has increased by 58.6% year-to-date, outperforming the MSCI China Index which rose by 24.2% [1] - The recent slight pullback in the healthcare sector (10% decline in MSCI China Healthcare Index since October) presents a buying opportunity [1] - The recovery in capital market financing and the increase in overseas transactions for innovative drugs indicate a rebound in domestic innovative drug R&D demand [1] Group 2: Clinical Data and Drug Development - SKB264 is the only drug showing statistically significant overall survival (OS) in a Phase III trial for EGFR-TKI resistant NSCLC, with a hazard ratio (HR) of 0.56 compared to chemotherapy [2] - Ivonescimab demonstrated a median progression-free survival (mPFS) of 11.1 months in first-line sqNSCLC, outperforming the comparator at 6.9 months (HR=0.60) [2] - The uORR for drug 707 in first-line colorectal cancer reached 82.6%, with a cORR of 65.2%, indicating strong efficacy [2] Group 3: Strategic Collaborations and Future Outlook - The company suggests focusing on the clinical advancement of authorized pipelines overseas, as this has a higher certainty of success and can act as a catalyst for stock price increases [3] - The strategic collaboration between Innovent Biologics and Takeda for IBI363 involves shared global R&D costs and commercial rights, reflecting confidence in the drug and commitment to global strategy [3] - Pfizer is expected to announce overseas clinical plans for drug 707 within the year, with a focus on its combination with multiple ADC products [3]