Market Performance - The pharmaceutical and biotechnology index declined by 2.62% from November 3 to November 7, underperforming the Shanghai Composite Index by 2.37 percentage points, marking seven consecutive weeks of underperformance [1] - The innovative drug sector (BK1106) fell by 3.51% during the week, while the Hang Seng Healthcare Index dropped by 2.39% and the Hong Kong innovative drug ETF (513120) decreased by 3.92% [1] Industry Commentary - After a strong rally, the innovative drug industry has entered a bubble-popping phase, with a return to rational investment not necessarily being negative for the sector. However, the current market adjustment appears excessive, with leading companies like Kangfang Biotech, Zai Lab, and Kelun-Biotech experiencing declines exceeding 30% [2] - Zai Lab's recent performance has been impacted by two public announcements: disappointing clinical data for its gastric cancer drug Bemarituzumab and a Q3 report showing total revenue of $116 million, a 14% year-on-year increase, but a net loss of $35.96 million, which is a narrowing of losses compared to the previous year. Revenue growth was primarily driven by sales of "Nusinersan" and "Dingyoule," offset by a slowdown in "Zele" sales [2] Short-term Outlook - In the short term, the innovative drug industry is undergoing emotional recovery and valuation reconstruction, with stock volatility heavily influenced by clinical data and earnings guidance. Zai Lab faces short-term emotional pressure due to the termination of a key clinical trial and downward adjustments in performance expectations. However, from a medium to long-term perspective, the innovative logic of the industry remains unchanged, with globally competitive pipeline assets being the core support for company valuations [3] IPO Developments - Nanjing Haina Pharmaceutical Technology Co., Ltd. has submitted an IPO application to the Hong Kong Stock Exchange, with CICC as the sole sponsor. This follows the termination of a major asset restructuring plan in June 2023, where Haina was to be acquired by Chengdu Xian Dao [4] - Haina Pharmaceutical, established in 2001, integrates drug research and manufacturing, providing CXO services and proprietary product pipelines. The company's revenue primarily comes from CXO services, with 398 ongoing CXO projects as of mid-2025 [4] Financial Performance - For 2024, Haina Pharmaceutical projects revenue of 425 million yuan, a year-on-year increase of 3.65%, but a net profit of 53.295 million yuan, reflecting a 27% decline, indicating a situation of "increased revenue but decreased profit." In the first half of the year, both revenue and net profit saw declines of 16.97% and 25.82%, respectively, attributed to a decrease in CRO service income and a 45.8% drop in sales of proprietary drugs [5] Clinical Trial Updates - From November 3 to November 7, the National Medical Products Administration disclosed 110 new clinical trial registrations, with 33 of these being innovative drugs in Phase II or above, primarily covering oncology, immunology, cardiovascular, and psychiatric fields [6] - Four innovative drugs were approved during the week [7] Notable Approvals - The first CAR-T therapy in China, Pucalunase injection (pCAR-19B), was approved for treating pediatric acute B lymphoblastic leukemia patients aged 3 to 21. This drug was previously included in breakthrough therapy and priority review categories [8] - Pucalunase is the fifth CD19 CAR-T product approved in China, following four others from various companies [9]

Group 1 - The core viewpoint of the article highlights the recent performance of the innovative drug sector, indicating a market correction phase after a strong rally, with significant declines in stock prices for leading companies like 康方生物 and 再鼎医药 [5][6][4] - The innovative drug index and related ETFs have shown declines, with the Hang Seng Healthcare Index down by 2.39% and the Hong Kong innovative drug ETF down by 3.92% over the week [4][5] - Recent clinical trial results for 再鼎医药's gastric cancer drug 贝玛妥珠单抗 were disappointing, leading to a halt in its clinical study due to insufficient efficacy [5][6] Group 2 - 海纳医药 has submitted an IPO application to the Hong Kong Stock Exchange after failing to complete a major asset restructuring to enter the A-share market [7][8] - The company primarily generates revenue from its CXO services, with 398 ongoing CXO projects as of mid-2025 [7] - 海纳医药's revenue for 2024 is projected at 425 million yuan, reflecting a year-on-year growth of 3.65%, but its net profit is expected to decline by 27% [8] Group 3 - The first CAR-T therapy for treating pediatric leukemia, 普基仑赛, has been approved for market release in China, marking a significant milestone in innovative drug development [13][12] - The approval of 普基仑赛 follows a series of clinical trials and regulatory reviews, emphasizing its potential in treating acute B-cell leukemia in children aged 3 to 21 [13][12] - The article notes that this is the fifth CD19-targeting CAR-T product approved in China, indicating a growing market for such therapies [14]