Group 1 - Hong Kong Exchanges and Clearing CEO stated that simultaneous listings of Greater Bay Area companies in Hong Kong and Shenzhen will help expand investor coverage without diluting market liquidity [1] - The Hong Kong Stock Exchange is currently processing over 160 listing applications, with nearly 20 companies expected to raise over $1 billion each [1] - The Hong Kong Securities and Futures Commission is actively promoting the inclusion of RMB counter in Stock Connect, which is expected to launch by the end of the year [1] Group 2 - Nasdaq China Golden Dragon Index rose by 2.07%, with major US stock indices also showing gains, including a 0.75% increase in the Dow Jones Industrial Average [2] - Popular Chinese concept stocks mostly rose, with Futu Holdings up over 10% and Bilibili up over 5% [2] Group 3 - The National Development and Reform Commission reported that pig prices have hit a 17-month low, with the average price at 14.45 yuan per kilogram, down 1.77% from previous periods [3] Group 4 - Guangdong Province is supporting the innovation and development of radioactive drugs, focusing on new targets and mechanisms for drug research [4] Group 5 - WeChat announced that public accounts can now link to WeChat stores, allowing users to display and sell products directly through their accounts [5] Group 6 - China Shenhua reported a 10.7% year-on-year decrease in coal sales volume for May, attributed to weak downstream demand [6] Group 7 - Hong Kong Broadband announced the establishment of an independent board committee to provide recommendations regarding China Mobile's offer [7] Group 8 - Fosun Pharma and Teva have entered a strategic partnership to jointly develop the anti-PD1-IL2 therapy, with Fosun obtaining exclusive rights for development in China and certain Southeast Asian countries [8] Group 9 - Nanshan Resources expects annual profit to increase from approximately 37.7 million HKD to at least 80 million HKD for the fiscal year ending March 31, 2025 [9] Group 10 - Dongfang Zhenxuan launched its first self-operated sanitary napkin product, achieving sales of over 300,000 packs shortly after launch [10] Group 11 - Zijin Mining and Ajilan Mining are in the process of establishing a joint venture in Saudi Arabia to explore and develop mineral resources [11] Group 12 - Haitan Flavor Industry's IPO in Hong Kong received an oversubscription of approximately 930 times from retail investors [12] Group 13 - China Software International launched its self-developed Hongyun virtual machine, enabling seamless compatibility with Windows software on HarmonyOS [13] Group 14 - China Biopharmaceutical's TDI01 suspension has been included in the breakthrough therapy designation program for treating chronic graft-versus-host disease [14]

Core Viewpoint - Beijing Xiantong International Pharmaceutical Technology Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, with CICC and CITIC Securities as joint sponsors [1] Financial Performance - The company reported a net loss attributable to the parent of RMB 297 million in 2023 and RMB 149 million in 2024 [2][5] - Revenue for 2023 was RMB 10.23 million, increasing to RMB 44.064 million in 2024 [5][7] - The company incurred significant research and development expenses exceeding RMB 296 million in 2023 and RMB 228 million in 2024 [6][7] Market Focus - The company is focused on developing and commercializing radioactive drugs, aiming to become the first listed company in China with innovative or best-in-class products in this field [3] - The product pipeline includes 15 assets, with four core products: XTR008, XTR006, XTR004, and XTR003, targeting oncology, neurodegenerative diseases, and cardiovascular diseases [3] Market Growth - The global radioactive drug market is projected to grow from USD 5 billion in 2018 to USD 9.7 billion by 2024, with a compound annual growth rate (CAGR) of 11.7% [5] - In China, the market is expected to increase from RMB 3.6 billion in 2018 to RMB 7.4 billion by 2024, with a CAGR of 13.0% [5] Customer Concentration - The company has a high customer concentration, with revenue from the top five customers accounting for 95.7% in 2023 and 93.3% in 2024 [7] Shareholder Structure - The largest shareholder group holds approximately 27.03% of the voting rights as of May 23, 2025 [8] Fundraising Purpose - The funds raised will be used for the research and registration of core products, development of other candidate products, and enhancement of sales and marketing capabilities [9]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [8] - Research and development expenses for Q1 2025 were approximately $3.4 million, a decrease from approximately $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities and personnel costs [9] - General and administrative expenses for Q1 2025 were $3 million, down from $4.9 million in the same period in 2024, driven by reductions in pre-commercialization and personnel costs [9] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024, reflecting a substantial improvement in financial performance [9] Business Line Data and Key Metrics Changes - The company is focusing on its PDC platform and radio conjugate pipeline, particularly the iapoficine I-131 for treating Waldenstrom's macroglobulinemia, which has shown promising efficacy and safety in clinical trials [5][6] - The company is also advancing its solid tumor-focused radioisotope programs, including treatments for pancreatic cancer and triple-negative breast cancer [6] Market Data and Key Metrics Changes - The company is seeking guidance from the EMA for conditional approval of iapoficine I-131 based on the results from the Phase II CLOVER WM clinical trial, which supports a rapid market entry for this treatment in Europe [5][6] - The management believes that the European market presents a significant opportunity, especially given the high utilization of rituximab in the region [42] Company Strategy and Development Direction - The company has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including mergers, acquisitions, partnerships, and licensing arrangements [7] - The management is committed to advancing its clinical development pipeline and addressing the unmet medical needs in the relapsed-refractory market [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for iapoficine I-131, highlighting the strong data supporting its efficacy and safety [5][6] - The management noted the high unmet medical need in the patient population, particularly for those who have failed previous treatments [33] Other Important Information - The company is preparing for Phase I and Phase Ib studies for its earlier-stage radio conjugates, CLR121225 and CLR121.125, which are expected to provide valuable insights into their therapeutic potential [13][15] - The timeline for conditional approval from the EMA is anticipated in the third quarter of 2026, with a subsequent filing expected to take approximately twelve months for review [43] Q&A Session Summary Question: Regarding the application for conditional approval in Europe - The management discussed the potential for iapoficine I-131 to compete against rituximab in earlier lines of therapy, noting the challenges and costs associated with larger study sizes [19][22] Question: What is the weakest competitor arm for the Phase III trial? - Management indicated that there is little data available for many treatments in the NCCN guidelines, and they are focused on demonstrating the efficacy of iapoficine I-131 against existing therapies [25][29] Question: How does the company assess the commercial opportunity in Europe? - The management believes that the European market is rich, with a high utilization of rituximab, and that demonstrating superiority in clinical trials could enhance market positioning despite lower pricing [36][42]

Financial Data and Key Metrics Changes - The company reported net product revenues of $20.9 million for the first quarter of 2025, an 8% increase from $19.4 million in the same period last year [21][24] - The net loss for the quarter was $5.2 million, or a negative $0.12 per share, compared to a net loss of $6.6 million, or a negative $0.15 per share, in Q1 2024 [24][26] - Cash and cash equivalents at the end of Q1 2025 were $60.3 million, down from $67.2 million at the end of 2024 [25][26] Business Line Data and Key Metrics Changes - The Danielza business unit achieved net product revenues of $20.9 million, with U.S. revenues at $13.4 million, down 28% year-over-year, while ex-U.S. revenues were $7.5 million, an increase of $6.7 million [17][21] - The segment profit margin for the Danielza business unit was 42% in Q1 2025, compared to 44% in Q1 2024 [25] - The radiopharmaceuticals business unit reported a segment loss of $6.1 million for Q1 2025, slightly higher than the $6.0 million loss in Q1 2024 [25] Market Data and Key Metrics Changes - The company noted a slowdown in new patient enrollment in the U.S. due to competitive pressures and market dynamics, impacting revenue [18][19] - The addition of Danielza to the NCCN guidelines is expected to enhance its market position and clinician adoption [19][100] Company Strategy and Development Direction - The company has realigned its business into two distinct units: Danielza and Radiopharmaceuticals, aiming to maximize the potential of each [9][25] - Upcoming events include a virtual radiopharmaceutical R&D event on May 28, where key updates on clinical trials and pipeline developments will be shared [11][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations into 2027, despite current challenges [10][26] - The company anticipates a realistic revenue guidance for Q2 2025 between $17 million and $19 million, factoring in seasonality and historical trends [26][40] Other Important Information - The company is monitoring potential tariff impacts on its supply chain, expecting minimal effects at this time [27] - The company continues to focus on advocacy development and expanding its market reach for Danielza [75][100] Q&A Session Summary Question: Dynamics of U.S. and ex-U.S. revenue for Danielza - Management noted steady growth outside the U.S. and a slower start in the U.S. due to competitive pressures, but an uptick in enrollments is expected [30][32] Question: Q2 revenue guidance and historical trends - Management acknowledged seasonality and historical stock-in dynamics affecting Q2 guidance, projecting slight growth in U.S. sales [38][40] Question: Plans for naxitamab in osteosarcoma - The company is supporting ongoing studies and looking to improve diagnostics for GD2 expression [47][48] Question: Medicaid reserve adjustments - Management indicated stabilization in Medicaid gross-to-net elements, with no major changes anticipated for 2025 [59][62] Question: Impact of new linker on CD38 study - The current CD38 study will maintain its construct while safety data is established before any changes are made [65][84] Question: Stabilization in cycles per patient for Danielza - Management reported consistent volumes per facility, focusing on penetrating larger accounts rather than just the number of vials per patient [89][90] Question: NCCN guidelines impact on Danielza growth - Inclusion in the NCCN guidelines is expected to remove previous headwinds and provide opportunities for increased clinician discussions [99][100]