Dr Reddy's Laboratories Ltd（RDY）資訊與事件RDYDr Reddy's Laboratories Ltd

Immutep Updates Development Strategy for eftilagimod alfa

Immutep (IMMP) provided an update on its development strategy for eftilagimod alfa. Following the early discontinuation of the TACTI-004 study, Immutep has been conducting a detailed root cause analysis covering clinical, pharmacological and manufacturing aspects. This ongoing root cause analysis has identified structural differences between the efti used in TACTI-004 and the efti used in earlier successful clinical studies. These differences are considered potentially relevant given the markedly different immune activation profile observed in TACTI-004 compared to previous trials and the unexpected clinical outcome of the study. Based on the currently available data from the Root Cause Analysis to date, Immutep believes that the unexpected outcome of TACTI-004 cannot be explained by clinical factors or trial execution factors. The company will provide a further update on completion of the root cause analysis. Based on the findings from the root cause analysis to date, Immutep has contracted a manufacturing run of efti at 200 L scale. Ten GMP batches of efti have previously been manufactured at 200 L scale and used in successful Phase I and Phase II clinical studies of efti, including TACTI-mel, TACTI-002 and INSIGHT-003. In contrast, TACTI-004 was conducted exclusively with efti manufactured at 2,000 L scale. Immutep currently intends to focus the registration-directed clinical development of efti on: HNSCC in patients with CPS less than 1 - based on clinical efficacy data, including mature overall survival data, in a patient population with high unmet need and limited approved treatment options, and for which efti has received Fast Track designation and FDA feedback that the Company considers constructive; and the neoadjuvant setting of STS - based on positive Phase II data, including achievement of the primary endpoint, and for which efti received Orphan Drug Designation from the FDA in April. This focus reflects the compelling clinical data generated to date, the company's interactions with the FDA, regulatory designations obtained, unmet medical need and substantial market potential in these indications. Preparations for the next clinical trials have commenced. Subject to final decisions on strategy and trial design, regulatory interactions, manufacturing timelines, partnering and resources, Immutep is targeting study start during 2H CY27. Immutep's licensing partner, Dr. Reddy's (RDY), has been consulted on and is supportive of this approach. The company is also in preliminary discussions with other parties regarding the proposed development pathway.

Fresenius Kabi Receives FDA Approval for Rituximab Biosimilar

Fresenius Kabi, an operating company of Fresenius (FSNUY), announced that the U.S. Food and Drug Administration has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories, a biosimilar to Rituxan. Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the biosimilar in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories (RDY). "FDA approval of rituximab biosimilar represents an important milestone for Fresenius Kabi, further strengthening our U.S. biosimilars footprint with a well-established molecule that strategically complements our oncology and immunology portfolios. This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.

Innoviva Signs Exclusive Distribution Agreement with Dr. Reddy's for XACDURO

Innoviva Specialty Therapeutics, a subsidiary of Innoviva (INVA), announced that it has entered into an exclusive distribution and licensing agreement with Dr. Reddy's Laboratories (RDY) for the development and commercialization of XACDURO, co-packaged for intravenous use, in South and Central America, the Caribbean, Russia and Commonwealth of Independent States countries. Under the terms of the agreement, Dr. Reddy's will be responsible for development, regulatory and commercialization activities in the licensed territory. Innoviva Specialty Therapeutics will retain rights to XACDURO in all unlicensed territories and is eligible to receive an upfront payment, regulatory and commercial milestone payments, and tiered royalties on net sales in the licensed territory.