Group 1 - The Hong Kong stock market opened higher on June 5, with the Hang Seng Index rising by 0.63% and the Hang Seng Tech Index increasing by 0.65% [1] - The Hong Kong Innovative Drug ETF (159567) saw a rise of 1.26%, with a turnover rate of 16.38% and a trading volume exceeding 280 million yuan, indicating active trading [1] - Notable stocks within the ETF included Zai Lab, which rose over 7%, Hutchison China MediTech, which increased over 4%, and Luye Pharma, which gained over 3% [1] Group 2 - China National Pharmaceutical Group announced that its Bemarituzumab injection combined with Anlotinib capsules achieved a median progression-free survival (PFS) of 11 months in treating PD-L1 positive advanced non-small cell lung cancer, outperforming the global leader Pembrolizumab by 3.9 months [1] - According to Zhongtai Securities, the Chinese innovative drug industry is transitioning from a previous capital bubble to a phase of genuine results, suggesting a positive outlook for the pharmaceutical sector [1] - The report recommends actively investing in segments expected to recover, such as CRO&CDMO, upstream research, specialty raw materials, chain pharmacies, and branded OTC products [1] Group 3 - Guoyuan Securities stated that China's innovative drugs have gained recognition from large overseas pharmaceutical companies, demonstrating that the R&D capabilities are internationally competitive and a key driver for growth [2] - The innovative drug sector in China is entering a phase of realization of results, with numerous catalysts in R&D progress, which is expected to remain a main investment theme in the pharmaceutical sector through 2025 [2]

Summary of Zai Lab (ZLAB) 2025 Conference Call Company Overview - **Company**: Zai Lab (ZLAB) - **Event**: 2025 Conference Call held on June 4, 2025 Key Industry Insights - **Market Focus**: Zai Lab is actively executing its commercial strategy in China, particularly with its product Vivgart and its wholly owned pipeline of drugs [2][5][6] - **Sales Guidance**: For 2025, Zai Lab has provided a sales guidance range of $560 million to $590 million, indicating a growth rate of over 40% [5][6] Core Product Insights - **Vivgart Performance**: - First quarter sales for Vivgart were $18 million, which was lower than expected due to seasonal impacts from the Chinese New Year [7][8] - Total sales for Vivgart in its first year reached $93 million, showcasing strong initial market acceptance [7] - Anticipated strong sequential growth for Vivgart in Q2, Q3, and Q4, driven by increased patient utilization and changes in treatment guidelines [14][19] - Current patient base on Vivgart is approximately 12,000, with a potential market of 150,000 patients in China [16] Regulatory and Pricing Strategy - **NRDL Negotiation**: Zai Lab is approaching the two-year reset for Vivgart's pricing under the National Reimbursement Drug List (NRDL), with expectations of a single-digit price decline [21][25] - **New Indications**: Zai Lab is pursuing additional indications for Vivgart, including a subcutaneous version and a new indication for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [26][29] Pipeline Developments - **DLL3 ADC Program**: - Zai Lab presented promising data at ASCO for its DLL3 ADC program in small cell lung cancer, reporting a 79% overall response rate with a favorable safety profile [41][42] - Plans to initiate a pivotal study for DLL3, with data expected in 2026 for accelerated approval [50][68] - **IL-13 Bispecific Antibody**: - Zai Lab is developing an IL-13 bispecific antibody, expected to start Phase 1 trials later this year, with potential advantages in dosing frequency and efficacy [71][78] Commercial Strategy - **Sales Force Considerations**: Zai Lab is open to establishing its own sales force in the U.S. for DLL3, while also considering partnerships [80][81] - **Focus on Oncology and Immunology**: The company aims to leverage its expertise in oncology and immunology for future business development and drug acquisitions [90][88] Additional Insights - **Market Competition**: Zai Lab acknowledges competition in the DLL3 space but believes its product has a clear value proposition due to its administration advantages [51][56] - **Long-term Profitability**: The company aims to achieve profitability by the end of 2025, with a focus on maintaining flat operational expenses while growing sales [32][35] This summary encapsulates the key points discussed during the Zai Lab conference call, highlighting the company's strategic direction, product performance, and market positioning.

Core Viewpoint - The U.S. stock market opened with slight gains, with the Nasdaq China Golden Dragon Index rising by 0.77% [1] Company Performance - Zai Lab (ZLAB.O) experienced a significant increase, rising by 9.4% [1] - Miniso Group (MNSO.N) also saw a notable gain, increasing by 4.7% [1]

Group 1 - The pharmaceutical sector has shown strong performance recently, with the Hang Seng Innovation Drug ETF (159316) and the Hong Kong Stock Connect Pharmaceutical ETF (513200) both experiencing significant gains, tracking indices that rose over 4% [1] - The National Medical Products Administration of China has approved 11 new drugs for market launch, covering various fields including oncology and endocrinology, with several being the "first in China" or "first domestic" in their respective categories [1] - Among the 11 new drugs, 7 are classified as Category 1 drugs, representing the highest level of drug innovation in China's registration classification system [1] Group 2 - Institutions indicate that favorable domestic policies are emerging to encourage high-quality innovation, which may continue to drive rapid growth in corporate performance, with commercial insurance development potentially benefiting the sustained release of innovative products [2] - The valuation levels of domestic innovative drugs are considered low, with some products having the potential to be the best in their global category, suggesting a positive outlook for innovative drugs to enter international markets and achieve premium valuations [2] - The Hang Seng Innovation Drug ETF (159316) tracks the Hang Seng Hong Kong Stock Connect Innovation Drug Index, which includes leading companies in the innovative drug sector listed on the Hong Kong Stock Connect [2]

Group 1 - The Hong Kong pharmaceutical sector is experiencing significant growth, with the CSI Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index rising by 3.97% as of June 4, 2025, and notable increases in individual stocks such as Innovent Biologics (up 16.22%) and Zai Lab (up 8.07%) [1] - The Hong Kong pharmaceutical ETF has shown strong performance, with a weekly increase of 4.31% and a current price of 0.8 yuan, indicating active market trading with a turnover rate of 19.73% [1] - The Chinese innovative drug sector is rapidly developing, with a 26% year-on-year increase in the total transaction amount for License-out deals, reaching $51.9 billion in 2024, highlighting the growing international recognition of Chinese innovative drugs [2] Group 2 - The number of oral presentations for Chinese innovative drug assets at ASCO reached a record high of 73, indicating a robust pipeline and increasing investor interest in the sector [2] - The CSI Pharmaceutical and Medical Device Innovation Index rose by 0.55% as of June 4, 2025, with significant contributions from stocks like Kelun Pharmaceutical (up 5.37%) and Bai Li Tianheng (up 2.65%) [4] - The Medical Innovation ETF has a current scale of 1.516 billion yuan, reflecting strong investor confidence and market activity [4][5] Group 3 - Leveraged funds are increasingly investing in the Medical Innovation ETF, with a latest financing buy-in amount of 1.2824 million yuan and a financing balance of 50.9157 million yuan [5] - The top ten weighted stocks in the CSI Pharmaceutical and Medical Device Innovation Index account for 66.57% of the index, indicating a concentration of investment in leading companies such as Heng Rui Medicine and WuXi AppTec [5] - The top ten weighted stocks in the CSI Hong Kong Stock Connect Pharmaceutical and Health Comprehensive Index represent 60.77% of the index, showcasing the dominance of key players like BeiGene and Innovent Biologics [6]

Group 1 - The Hong Kong Technology ETF (513560) has shown strong performance, with a recent increase of 1.96% and a trading volume of 60.53 million yuan, indicating active market participation [2] - The index it tracks, the CSI Hong Kong Stock Connect Technology Index (931573), has seen significant gains, with notable increases in constituent stocks such as Innovent Biologics (01801) up 16.22% and Zai Lab (09688) up 7.45% [2] - The average daily trading volume of the Hong Kong Technology ETF since the beginning of 2025 is 445 million yuan, reflecting robust trading activity [2] Group 2 - The Hong Kong Technology ETF has reached a new high in scale at 524 million yuan, with a recent increase of 16 million shares over the past week, ranking second among comparable funds [3] - Over the past year, the net value of the Hong Kong Technology ETF has increased by 59.78%, placing it first among comparable funds [3] - The ETF has demonstrated a historical return capability, with a maximum monthly return of 26.15% and an average monthly return of 8.83% [3] Group 3 - The Hong Kong Technology ETF has a management fee of 0.50% and a custody fee of 0.10%, contributing to its overall cost structure [4] - The ETF's tracking error over the past three months is 0.213%, indicating the highest tracking precision among comparable funds [4] - The current price-to-earnings ratio (PE-TTM) of the CSI Hong Kong Stock Connect Technology Index is 21.9, which is below 94.42% of the historical data over the past year, suggesting a low valuation [4] Group 4 - The top ten weighted stocks in the CSI Hong Kong Stock Connect Technology Index account for 71.48% of the index, with major companies including Xiaomi (01810), BYD (01211), and Alibaba (09988) [4] - Investors without stock accounts can access the Hong Kong Technology ETF through linked funds, providing an opportunity to invest in the innovative pharmaceutical sector [6]

Core Viewpoint - The Hong Kong stock market is expected to open higher, with a positive pre-market performance in the innovative drug sector, driven by significant approvals for new drugs in China [1] Group 1: Market Performance - The Hong Kong innovative drug index constituents saw notable gains, with Innovent Biologics rising over 6%, and other companies like Zai Lab and WuXi AppTec increasing by over 2% [1] - The Hong Kong innovative drug ETF (159567) experienced a net inflow of over 165 million yuan in the past 20 trading days, indicating high market enthusiasm [1] - The price-to-earnings ratio of the Hong Kong innovative drug index decreased from 64 times on February 21 to 27 times on June 4, highlighting improved value for investors [1] Group 2: Regulatory Developments - On May 29, the National Medical Products Administration of China approved 11 innovative drugs, including 7 first-class innovative drugs, marking a historic moment for the sector [1] - Over 20 first-class innovative drugs have been approved from January to May, setting a record for the same period in the past five years [1] - The Chinese pharmaceutical industry is transitioning from "follow-up innovation" to "global leadership," focusing on clinical value in key areas like targeted cancer therapies and immunotherapy [1] Group 3: Investment Opportunities - The innovative drug ETF (159567) tracks the National Index of Hong Kong Innovative Drugs, with 90% of its weight in innovative drug companies, positioning it to benefit from trends like AI-enabled drug development and the expansion of domestic innovative drugs [1] - The innovative drug ETF (159992) encompasses leading companies in the innovative drug industry chain, benefiting from AI advancements and the introduction of new drug reimbursement policies [2] - The domestic innovative drug sector is expected to show strong growth and investment value in the first half of 2025, driven by ongoing international collaborations and the approval of new drugs [2]

Financial Data and Key Metrics Changes - The company reported a confirmed overall response rate (ORR) of 68% and a disease control rate of 93% across all dose levels in the ongoing clinical trial for ZL1310 [12][21] - The median follow-up for the efficacy evaluable patients was 3.4 months, with some patients remaining in response for over 9 months [22][43] Business Line Data and Key Metrics Changes - ZL1310, the investigational DLL3 targeted antibody-drug conjugate, demonstrated promising clinical activity in patients with relapsed or refractory extensive stage small cell lung cancer [6][19] - The safety profile of ZL1310 was reported as manageable, with only 16% of patients in the low-dose group requiring dose interruptions [10][19] Market Data and Key Metrics Changes - Small cell lung cancer accounts for approximately 15% of all lung cancers, affecting around 372,000 patients worldwide, with a poor prognosis and a median overall survival of about 13 months [6][19] - The estimated global prevalence of DLL3 expressing neuroendocrine carcinomas is roughly 350,000 to 400,000 patients, indicating a significant market opportunity for ZL1310 [26] Company Strategy and Development Direction - The company plans to initiate a registrational study in second-line small cell lung cancer later this year, with overall survival as the primary endpoint [22][23] - There is a strategy to expand ZL1310 into first-line small cell lung cancer and other DLL3 expressing solid tumors, aiming to reduce treatment burden for patients [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for accelerated approval based on the promising data and ongoing discussions with the FDA [56][57] - The company is optimistic about the efficacy of ZL1310 in the competitive landscape, particularly in comparison to existing therapies [48][49] Other Important Information - The company is exploring combination therapies with ZL1310, including carboplatin and atezolizumab, to enhance treatment efficacy [38][39] - The company has received fast track designation from the FDA, which may facilitate the development process [32] Q&A Session Summary Question: Can you comment on the therapeutic window and confidence in the selected dose for pivotal studies? - Management indicated that the 1.6 mg/kg dose shows a good balance of efficacy and safety, with a slight attrition in response at higher doses [29][30] Question: What is the dosing strategy and safety consideration for the combination trial? - The company is methodically exploring combinations with existing chemotherapy regimens and is confident in the competitive activity of ZL1310 [37][38] Question: How does the durability of ZL1310 compare to competitors in refractory small cell lung cancer? - Management noted that the durability of response is clinically meaningful, with a median follow-up of 6.9 months for the most mature data set [42][43] Question: What gives confidence in potential accelerated approval for ZL1310? - Ongoing discussions with the FDA suggest that accelerated approval is a viable option, contingent on the results of the randomized trial [56][57] Question: What are the remaining items to align with the FDA before initiating the pivotal study? - The main focus is to finalize the dosing strategy and ensure alignment on study design with the FDA [65][66]

ZL-1310 Overview - ZL-1310 is a DLL3-targeted antibody-drug conjugate (ADC) showing promising clinical activity in relapsed/refractory (r/r) ES-SCLC patients[21] - The ADC has a drug-to-antibody ratio (DAR) of 8[20, 21] Safety Profile - ZL-1310 demonstrated a well-tolerated safety profile in the study[28] - In patients receiving doses < 2.0 mg/kg, Grade ≥3 TRAEs occurred in 6% of patients, and serious TRAEs occurred in 4% of patients, with no TRAEs leading to drug discontinuation or death[28] - At doses ≥2.0mg/kg, any TEAE occurred in 95% of patients, with Grade ≥3 in 44% of patients[27] Efficacy in SCLC - In the dose escalation cohort (N=28), the confirmed ORR was 68%[33] - In 2L SCLC (N=33), the ORR was 67% and the Disease Control Rate (DCR) was 97%[37] - For patients with 1 prior line of therapy (N=33), the ORR was 67% and the DCR was 97%[38] - In patients with brain metastases at baseline (N=22), the ORR was 68%, and in those without prior radiation (N=7), the ORR was 86%[55] Study Design and Future Plans - A Phase 3 pivotal trial assessing ZL-1310 in ES-SCLC patients who have progressed during or after platinum-based therapy is planned to start later this year[56] - A randomized, registrational trial is initiating in 2H'25 with primary endpoints of OS and ORR[62]

Market Overview - The market experienced fluctuations in the early session, with the ChiNext Index leading the decline. The focus of the market was primarily on the consumer and pharmaceutical sectors [1] ETF Performance - Several ETFs related to innovative drugs saw significant gains, with the Hong Kong Stock Connect Innovative Drug ETF (159570) rising by 2.61% and the Hong Kong Innovative Drug ETF (159567) increasing by 2.22% [2] - The Hong Kong Innovative Drug ETF (513120) also rose over 2%, with a total scale of 95.23 billion, tracking the CSI Hong Kong Innovative Drug Index [5] Investment Logic - The innovative drug industry in China is expected to reach a turning point by 2025, shifting from capital-driven to profit-driven trends, presenting opportunities for both performance and valuation recovery [2] - A new round of technological advancements is anticipated to propel domestic innovative drugs into a new development phase [2] Key Stocks in Innovative Drug Sector - Notable companies in the innovative drug sector include: - Innovent Biologics (信达生物) with a market cap of 885.89 million - BeiGene (百济神州) with a market cap of 2,034.42 million - WuXi Biologics (药明生物) with a market cap of 938.65 million - Other significant players include CanSino Biologics (康方生物), China Biologic Products (中国生物制药), and Hengrui Medicine (翰森制药) [3][6][7] Index Composition - The CSI Hong Kong Innovative Drug Index selects up to 50 listed companies involved in innovative drug research and development, reflecting the overall performance of the innovative drug sector in the Hong Kong market [5][6]