The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a “significant milestone” in the prevention of the mosquito-borne disease. R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022. Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year. Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk. Dr Kate O’Brien, director of WHO’s department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”. “This ...
Millions of people across the world are diagnosed with colorectal cancer and endometrial cancer each year. A significant number of patients with these cancers exhibit mismatch repair deficiency, a genetic anomaly characterized by errors in DNA due to the absence of specific repair proteins. This deficiency hampers DNA repair capabilities, potentially leading to various cancer types. Prior studies have indicated that patients with this condition often show positive responses to immunotherapy, which leverages the body’s immune system to combat cancer. Now, a new study has broadened the scope of patients who might benefit from this treatment approach. A research team from Brigham and Women’s Hospital (Boston, MA, USA) conducted an analysis involving 1,655 patients with either colorectal or endometrial cancer. These patients underwent both immunohistochemistry, the prevailing standard test for this genetic state, and next-generation sequencing tests. Immunohistochemistry detects mutations impacting the antigen, while next-generation sequencing provides a more comprehensive ...
ROCKVILLE, U.S. and SUZHOU, China, Jan 2, 2024 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.A Phase 2 study conducted in Chinese people with obesity ...
Shanghai and Suzhou, TOKYO, December 28, 2023 – Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture and commercialize the products for each program. Elpiscience is a privately held, clinical-stage biopharmaceutical company dedicated to developing next-generation immuno-oncology therapies for cancer patients worldwide. Their Bispecific Macrophage Engager Platform (BiME®) is anti-tumor associated antigen (TAA) and anti-signal-regulatory protein α (SIRPα) bispecific antibody-based platform to activate Tumor Associated Macrophage (TAM) phagocytosis killing towards ...
ROCKVILLE, Md. and SUZHOU, China, Dec 28, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Xuanzhu Biopharma, today announce that they entered into a clinical trial collaboration and supply agreement for the combination therapies of sintilimab injection (brand name: TYVYT®) with KM-501, a novel HER-2 bispecific ADC, as potential treatment options for advanced solid tumors in China. Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial. Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors. TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China. It has been approved and included in ...
NFL players aim to boost awareness of Type 1 diabetes under a new charitable campaign. The “My Cause My Cleats” campaign will see NFL players wear custom-painted cleats during some football games to raise awareness and funds for charitable causes. In 2024, Type 1 diabetes has become a core theme, with Mark Andrews of the Baltimore Ravens, Orlando Brown Jr. of the Cincinnati Bengals, Blake Ferguson of the Miami Dolphins, Collin Johnson of the Chicago Bears, Chad Muma of the Jacksonville Jaguars, Nate Peterman of the Chicago Bears, and Kevin Radar of the Tennessee Titans, all lacing up for the cause. More than 1.4 million Americans are affected by Type 1 diabetes, an autoimmune disease that causes the pancreas to produce little or no insulin. The disease typically hits at a young age, and is separate from Type 2 diabetes, which typically affects adults and can be related to obesity. ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (27 December) approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. This is a cancer medicine used to treat advanced melanoma, a type of skin cancer that can spread to other areas of the body. The main risk factor for melanoma is exposure to ultraviolet light, which comes from the sun and is used in sunbeds. Around 17,000 cases of melanoma are diagnosed every year in the UK, although not all of those are advanced melanoma. Opdualag has been authorised through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration. This programme reviews and approves promising cancer drugs, helping patients to ...
Shanghai, China, December 28, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius’ partner PT Kalbe Genexine Biologics (KGbio), has received the relevant registration certificates issued by Indonesia’s National Agency for Drug and Food Control (Indonesian: Badan Pengawas Obat and Makanan, the “BPOM”) for the approval of Henlius’ self-developed and manufactured anti-PD-1 mAb HANSIZHUANG (serplulimab) in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer (ES-SCLC). This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. Currently, Henlius is joining hands with KGbio for the development and commercialisation in 22 countries, and the approval is expected to bring HANSIZHUANG to more patients in Indonesia. Lung cancer (LC) is one of the most ...
SHANGHAI, Dec. 26, 2023 /PRNewswire/ — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA). On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum. On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in ...
ROCKVILLE, Md. and SUZHOU, China, Dec 20, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.