ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 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, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor. The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). Welireg becomes the first drug in its class for patients with advanced RCC and the first novel-class treatment in the indication since 2015, Merck noted. The nod comes on top of its original approval to treat the rare von Hippel-Lindau disease, a hereditary condition that causes tumor growth in ...
Harbour BioMed’s Wholly-owned Subsidiary, Nona Biosciences, announced today that it has entered into an exclusive license agreement with Pfizer Inc. for the global clinical development and commercialization of Nona Biosciences’ MSLN-targeted antibody-drug conjugate (ADC), HBM9033. Under the terms of the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens. “We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise ...
Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. This week, the U.S. FDA approved US WorldMeds’ (USWM) Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior multiagent, multimodality treatment, USWM said in a press release. Between 700 and 800 cases of neuroblastoma are diagnosed in the U.S. each year, according to the American Cancer Society. Ninety percent of diagnoses occur before a patient is 5 years old and more than 50% of neuroblastoma cases are classified as high-risk. Approximately half of children with high-risk neuroblastoma don’t live more than five years past their diagnosis, USWM added. Avoiding relapse is ...
Chronic heartburn may indicate Barrett’s Esophagus (BE), a precancerous condition where the esophagus lining is damaged due to digestive fluids. Although BE itself doesn’t manifest symptoms, it significantly increases the risk of developing esophageal adenocarcinoma (EAC), a dangerous cancer. Many individuals with BE are unaware of their condition and consequently, their elevated cancer risk. Timely identification of BE and precancerous cells is crucial for effective monitoring and intervention, preventing the progression to fatal esophageal cancer. Now, an advanced test for detecting esophageal precancer has demonstrated improved assay efficiency and cost-effectiveness in comprehensive validation studies. Lucid Diagnostics (New York, NY, USA) has launched EsoGuard 2.0, its next-generation EsoGuard Esophageal DNA test. The EsoGuard test begins with extracting DNA from esophageal cells gathered using the EsoCheck Cell Collection Device. This DNA undergoes bisulfite conversion, tagging unmethylated sites. It then focuses on two genes, VIM and CCNA1, identifying 31 methylation sites linked to ...
Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online. GC012F demonstrated a 100% overall response rate (ORR) and 95% ...
Pharmaceutical Executive Editorial Staff Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer. Bristol Myers Squibb (BMS) has reached an agreement with SystImmune for the rights to codevelop and sell a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) in a deal that could exceed $8 billion. As part of the agreement, BMS will pay $800 million upfront to SystImmune and up to $500 million in contingent near-term payments.1 Should certain developmental, regulatory, and sales performance milestones be achieved, SystImmune would be eligible for additional payments that would bring the total for the agreement to approximately $8.4 billion.1 “Our collaboration with SystImmune allows us to strengthen our leadership in oncology and is consistent with our strategy to diversify beyond immuno-oncology to transform patient care,” said ...
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