Haisco(SZ:002653)2026-01-12 08:10Group 1: Overview of Collaboration - HaiSiKe's PDE3/4 overseas authorization aims to achieve a win-win model by retaining Chinese rights while sharing overseas profits, accelerating the molecule's international deployment [2] - The company anticipates a period of international harvest and business development explosion in 2026, with ongoing expansion into oncology and large molecules [2] - The TYK2 project (FTP637) successfully entered overseas markets through a NEWCO model, completing phases 1-3 of clinical trials in about five years [3] Group 2: Key Collaboration Details - Transaction partner: AirNexis, led by Frazier Fund, with a transaction amount exceeding $1 billion, including an upfront payment of over $100 million and milestone payments of $955 million, along with double-digit sales sharing [3] - AirNexis is responsible for overseas clinical development and commercialization, while HaiSiKe retains rights for HSK39004 in China and global exclusive rights for combination formulations [3] - HaiSiKe's focus is on long-term benefits and overseas development efficiency while ensuring the protection of Chinese rights [4] Group 3: Clinical Progress and Differentiation - HaiSiKe is advancing both inhalation suspension and dry powder inhalation formulations, with the latter being globally leading [5] - The key phase 2 data in China is expected to be released in Q1 2026, with plans to initiate phase 3 studies for COPD in Q2 2026, aiming for NDA submission by late 2027 or Q1 2028 [5] - AirNexis plans to conduct population pharmacokinetics studies, with an NDA submission in the U.S. anticipated by Q4 2028 and potential approval by Q1 2030 [5] Group 4: Future Development and Opportunities - HaiSiKe is actively pursuing multiple projects in CNS and oncology, with hopes to initiate 1-2 key clinical trials in oncology by 2026 [7] - The company aims to independently conduct clinical research in the U.S. to generate proof-of-concept data before seeking external authorization partnerships, which could lead to larger transaction amounts [7] - Future collaborations may also involve platform-based R&D capabilities with leading multinational pharmaceutical companies or top-tier overseas investment funds [7] Group 5: Research and Development Focus - The R&D direction will focus on perioperative, respiratory, autoimmune, and oncology fields, expanding into biologics, ADCs, and cyclic peptides [8] - Short-term goals include advancing the approval of环泊酚 in the U.S., while mid-term goals involve achieving overseas market entries for DPP1 and PDE3/4 projects [8] - Long-term objectives include learning international market regulations and building a scalable overseas team [8]