CHUGAI PHARM UNSP/ADR - CHGCY STOCK NEWS

Chugai Pharmaceutical and Biofourmis have renewed their partnership aimed at developing digital solutions to objectively assess and manage pain from endometriosis, a condition affecting about 10% of women of reproductive age. This collaboration, which began in July 2020, will leverage Biofourmis' virtual specialty care services in the U.S. and Chugai's R&D data. Key initiatives include developing technology for real-world pain measurement, advancing patient care, and utilizing data from Chugai's investigational product, AMY109, for endometriosis. The focus is on enhancing healthcare delivery and improving patient outcomes.

Roche has expanded its collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to enhance laboratory capabilities in regions severely impacted by HIV and tuberculosis. This initiative, known as Lab Networks for Health, aims to improve detection, prevention, and treatment outcomes in selected African, Eastern European, and Central Asian countries. The partnership will focus on workforce development, quality management systems, and multi-pathogen testing. With approximately 2 billion people infected with tuberculosis and over 38 million living with HIV, strengthening laboratory networks is essential for public health.

Roche (OTC-PINK:RHHBY) has expanded its collaboration with Janssen Biotech to enhance the development of companion diagnostics aimed at personalised healthcare. This new agreement, announced on February 9, 2023, will include a diverse range of technologies such as blood and tissue biomarkers, digital pathology, and next-generation sequencing. The collaboration aims to improve access to targeted treatment options for patients, exemplifying Roche's commitment to precision medicine. Successful projects may include new immunohistochemistry assays and advanced data analysis for patient identification.

Genentech has announced interim results from the Phase III HAVEN 7 study, revealing that Hemlibra® (emicizumab-kxwh) effectively prevents bleeding in infants with severe hemophilia A. Notably, 77.8% of participants experienced no bleeding episodes requiring treatment. The study included data from 54 infants and aims to confirm Hemlibra’s safety and efficacy. Data also support its favorable profile from real-world studies. Hemlibra is currently approved in over 100 countries for treating hemophilia A without factor VIII inhibitors.

Genentech, part of Roche Group, announced new data from its hematology portfolio at the 64th ASH Annual Meeting, highlighting the efficacy of Hemlibra in infants with severe hemophilia A. New findings also support Polivy's potential in treating previously untreated diffuse large B-cell lymphoma (DLBCL). Additional insights were shared on bispecific antibodies mosunetuzumab and glofitamab, demonstrating promising results in lymphoma treatment. Furthermore, crovalimab showed effectiveness in paroxysmal nocturnal hemoglobinuria. These advancements emphasize Genentech's commitment to addressing unmet medical needs in blood disorders.

Genentech announced positive results from the Phase III HAVEN 6 study of Hemlibra (emicizumab-kxwh), showing 66.7% of participants with moderate or mild hemophilia A experienced zero treated bleeds over a median follow-up of 55.6 weeks. The study demonstrated Hemlibra's favorable safety profile, with no new safety signals reported. Hemlibra is approved for treating hemophilia A in over 110 countries. The findings will support a submission to the European Medicines Agency for expanding the label to include non-severe hemophilia A patients.

Genentech announced interim results from the Phase III HAVEN 6 study of Hemlibra for treating moderate or mild hemophilia A without factor VIII inhibitors. Data presented on December 12, 2021, indicate Hemlibra has a favorable safety profile, with 80.3% of participants reporting no bleeding episodes needing treatment. Additionally, 90.1% experienced no joint bleeds. The study involved 71 participants, confirming low annualized bleeding rates. Common adverse effects included headache (14.1%) and injection site reactions (12.7%), but there were no serious thrombotic events reported.

Genentech announced significant advances in its hematology portfolio at the American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021. The Phase III POLARIX trial demonstrated that Polivy plus R-CHP significantly improved outcomes in newly diagnosed diffuse large B-cell lymphoma compared to standard treatments. Key findings on mosunetuzumab showed high response rates in relapsed follicular lymphoma patients. Additionally, interim data from the HAVEN 6 study indicated that Hemlibra is effective in patients with moderate to mild hemophilia A.

Chugai Pharmaceutical announced new data showing Enspryng's long-term efficacy in preventing relapses in patients with NMOSD. Over four years, 73% of patients in the SAkuraStar study and 71% in the SAkuraSky study remained relapse-free. The safety profile remains consistent across treatment periods, with no new safety signals. Enspryng allows for self-administration, enhancing treatment accessibility. Additionally, the company is launching the SAkuraBONSAI study to further explore disease progression in treatment-naïve patients.