Core Viewpoint - WuXi AppTec's CAR-T therapy, Relma-cel, has submitted Phase I study data for treating adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, indicating significant potential for this innovative treatment in a challenging therapeutic area [1][4]. Group 1: Study Overview - The Phase I study is a multicenter, open-label, dose-exploration trial designed to assess the safety and efficacy of Relma-cel in SLE patients, with doses set at 50×10^6, 75×10^6, and 100×10^6 CAR+T cells [1]. - As of July 2025, a total of 12 female patients have been enrolled, with a median age of 27 years and a median disease history of 9.5 years [2]. Group 2: Patient Characteristics - All enrolled patients exhibited moderate to severe active SLE, with a median SELENA-SLEDAI score of 10 [2]. - 100% of patients had renal involvement, and other affected systems included skin (50%), hematologic (50%), and joints (16.7%) [2]. Group 3: Efficacy Results - Among the 12 patients evaluated for 6-month efficacy, 100% achieved SRI-4 response, and 50% met LLDAS criteria, indicating promising therapeutic effects [2]. - Various disease activity scales showed a downward trend, suggesting significant efficacy of Relma-cel in managing SLE [2]. Group 4: Safety Results - Initial safety results indicated that 11 out of 12 patients experienced grade 1 cytokine release syndrome (CRS), with one patient experiencing grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) [3]. - No dose-limiting toxicities (DLT) were reported, highlighting the favorable safety profile of Relma-cel in this patient population [3]. Group 5: Future Prospects - The ongoing study aims to gather longer follow-up data, with the potential for Relma-cel to advance to the biologics license application (BLA) stage [4]. - The company anticipates further discussions with regulatory authorities to expedite the Phase II pivotal study, aiming to provide a breakthrough treatment option for SLE patients [4].

Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has submitted Phase I study data for relma-cel in adult patients with active systemic lupus erythematosus (SLE) to the National Medical Products Administration (NMPA) in China, which has accepted the data and processed the meeting application [1] Group 1 - WuXi Biologics has initiated a Phase I clinical trial for relma-cel targeting SLE patients [1] - The submission to NMPA indicates progress in the regulatory process for relma-cel in China [1] - Acceptance of the data by NMPA is a significant step towards potential market entry [1]

人民财讯10月21日电，成大生物(688739)10月21日公告，公司与中国科学院微生物研究所（简称"微生 物所"）近日签署《战略合作协议》，双方聚焦新发突发传染病领域，重点围绕虫媒传染病预防，联合 申报国家级、省部级科研项目，协同发力应对传染病防控。该协议属于意向性合作范畴，对公司2025年 度及未来业绩不构成直接影响。 ...

格隆汇10月21日丨成大生物(688739.SH)公布，公司与中国科学院微生物研究所(简称"微生物所")于近日 签署《战略合作协议》(简称"本协议")，双方聚焦新发突发传染病领域，重点围绕虫媒传染病预防，联 合申报国家级、省部级科研项目，协同发力应对传染病防控。 本次战略合作整合了微生物所病原学研究顶尖资源，与公司现有疫苗研发平台形成协同效应，将加速新 发突发传染病疫苗及生物药研发进程，进一步丰富公司创新管线布局。 ...

此次协议属于意向性合作范畴，对公司2025年度及未来业绩不构成直接影响，对公司业绩的具体影响需 视下一步具体项目推进和实施情况来确定。 成大生物(688739.SH)发布公告，公司与中国科学院微生物研究所(简称"微生物所")于近日签署《战略合 作协议》，双方聚焦新发突发传染病领域，重点围绕虫媒传染病预防，联合申报国家级、省部级科研项 目，协同发力应对传染病防控。 ...

Core Viewpoint - The stock of药捷安康-B (02617) experienced a significant decline of over 11% during trading, with a current drop of 9.74% to HKD 176.2, and a trading volume of HKD 591 million. The company announced plans to convert 44.9711 million domestic shares held by 10 shareholders into H-shares, representing approximately 11.33% of the total issued shares, pending regulatory approvals [1][1][1]. Group 1 - The company’s stock price fell sharply after a recent surge, indicating volatility in investor sentiment [1][1]. - The recent rebound from October 16 to 17 saw a cumulative increase of nearly 80%, driven by international short-term speculative funds [1][1]. - The rebound was characterized as a "window for unloading" by domestic major funds, suggesting that the primary holders were selling rather than buying [1][1]. Group 2 - The analysis from智通财经APP highlighted that the recent price surge was not supported by the main holding group, which instead became the largest sellers [1][1]. - The sustainability of the rebound is questioned, as it relies heavily on subsequent market participation and inflow of speculative funds [1][1].

Core Viewpoint - Kangfang Biopharma's drug Iwosimab (PD-1/VEGF dual antibody) has shown significant improvement in progression-free survival (PFS) compared to Tislelizumab in a Phase III clinical trial for advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extends PFS, achieving a median PFS of 11.14 months compared to 6.90 months for Tislelizumab, with a hazard ratio of 0.60 (P<0.0001), resulting in an absolute difference of 4.24 months [1] - The new indication application for Iwosimab in treating sq-NSCLC based on the HARMONi-6 study results has been accepted for review by the National Medical Products Administration (NMPA) [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the national medical insurance drug list, with 13 Phase III clinical trials currently in progress, covering various cancers including lung cancer and cholangiocarcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for EGFR-mutant locally advanced or metastatic non-squamous NSCLC after EGFR-TKI treatment, and the second for PD-L1 positive locally advanced or metastatic NSCLC [2] Group 3: Other Drug Developments - Cardunili has received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively advancing [3] - Cardunili is pursuing around 20 indications through combination therapies, with three indications currently approved in China [3]

Core Viewpoint - Kangfang Biopharma (09926) announced that its drug Iwosimab (PD-1/VEGF dual antibody) combined with chemotherapy achieved the primary endpoint of progression-free survival (PFS) in a Phase III clinical study for advanced squamous non-small cell lung cancer (sq-NSCLC), outperforming the comparator drug Tislelizumab combined with chemotherapy [1] Group 1: Clinical Research and Results - The HARMONi-6 study demonstrated that Iwosimab combined with chemotherapy significantly extended PFS compared to Tislelizumab combined with chemotherapy, with a median PFS of 11.14 months for Iwosimab versus 6.90 months for Tislelizumab (HR=0.60, P<0.0001), resulting in an absolute difference of 4.24 months [1] - Based on the positive results from the HARMONi-6 study, the supplemental new drug application (sNDA) for Iwosimab combined with chemotherapy for sq-NSCLC was accepted by the National Medical Products Administration (NMPA) in July 2025 and is currently under review [1] Group 2: Drug Approvals and Pipeline - Iwosimab has been included in the National Medical Insurance Drug List, with 13 Phase III clinical studies ongoing, covering various cancers including lung cancer, cholangiocarcinoma, and head and neck squamous cell carcinoma [2] - Iwosimab has received approval for two indications in China, with the first being for locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, which has been successfully included in insurance; the second indication for PD-L1 positive locally advanced or metastatic NSCLC is expected to receive NMPA approval in April 2025 [2] - The drug Kadunili has also received approval for a new indication in first-line treatment of cervical cancer, with approximately 10 Phase III or registration clinical trials actively progressing [2]

Core Viewpoint - Rongchang Biopharma (09995) shares increased by nearly 5%, closing at HKD 96.95 with a trading volume of HKD 706 million, driven by significant research presentations at the ESMO annual meeting in Berlin [1] Group 1: Research Highlights - Rongchang Biopharma presented 10 key studies at the ESMO annual meeting from October 17 to 21, 2025, including the pivotal Phase III study data of Vidisicimab for first-line treatment of urothelial carcinoma, which was prominently featured at the conference and published in the New England Journal of Medicine [1] - The Phase III clinical research data for Taitasip in treating IgA nephropathy will be presented as a "Late-Breaking Oral" report at the American Society of Nephrology (ASN) annual meeting scheduled for November 5 to 9, 2025, in Houston, USA [1] Group 2: Market Outlook - Huatai Securities believes that the dense data readouts validate the global competitiveness of the company's pipeline and are expected to accelerate its overseas expansion: 1) The overseas Phase I/II study of Vidisicimab is progressing steadily, with expectations for the 2LUC indication to achieve BLA by early 2026; 2) RC148 has received CDEBTD approval, and the overseas Phase I/II clinical trial has been approved by the FDA, indicating significant overseas potential; 3) The global Phase III enrollment for Taitasip is proceeding smoothly, with pSS expected to become the next key indication [1]

Core Viewpoint - Rongchang Biopharma (09995) experienced a nearly 5% increase in stock price, reaching HKD 96.95, with a trading volume of HKD 706 million, following the announcement of significant research findings at the 2025 European Society for Medical Oncology (ESMO) annual meeting in Berlin [1] Group 1: Research Highlights - Rongchang Biopharma presented 10 major studies at the ESMO annual meeting, including the Phase III study data of Vidisicimab for first-line treatment of urothelial carcinoma, which was prominently featured at the conference and published in the New England Journal of Medicine (NEJM) [1] - The Phase III clinical research data for Taitasip in treating IgA nephropathy will be presented as a "Late-Breaking Oral" report at the upcoming 2025 American Society of Nephrology (ASN) annual meeting in Houston, scheduled for November 5-9 [1] Group 2: Market Outlook - Huatai Securities believes that the dense data readouts demonstrate the global competitiveness of the company's pipeline and are expected to accelerate its overseas expansion: 1) The overseas Phase I/II study of Vidisicimab is progressing steadily, with expectations for the 2LUC indication to achieve BLA by early 2026 [1] - RC148 has received CDEBTD approval, and the overseas Phase I/II clinical trial has been approved by the FDA, indicating significant potential for international market entry [1] - The global Phase III enrollment for Taitasip is proceeding smoothly, with primary Sjögren's syndrome (pSS) expected to become a key indication [1]