IDO Inhibitor Stops Recruiting Patients in Multiple Clinical Trials
On May 2, Incyte announced that multiple late-stage clinical trials of epacadostat with MSD, Bristol-Myers Squibb, and Aslicon PD-1/PD-L1 drugs will stop the recruitment of patients. At the same time, Bristol-Myers Squibb also stopped several clinical trials with the PD-1 combination of the IDO inhibitor BMS-986205 that it acquired from Flexus for 1.25 billion. Not long ago, in Phase III clinical trial ECHO-301/KEYNOTE-252, Incyte and Merck’s Epacadostat/Keytruda combination therapy did not achieve the primary endpoint of progression-free survival (PFS) in unresectable/metastatic melanoma patients. The failure of the announcement resulted in a $3 billion decline in Incyte’s market value.
Zhifei Biological obtains Merck’s nine-price HPV vaccine agency
On May 2, Zhifei Biological announced that it signed an agreement with Merck East Pharmaceutical Co., Ltd. Zhifei Bio will continue to serve as a market service provider for Merck in mainland China (excluding Hong Kong, Macau, and Taiwan), and will be responsible for the import of the Merck-duck human papilloma virus vaccine (Saccharomyces cerevisiae, 9-valent HPV vaccine) products in the Chinese mainland market. , distribution and promotion work. The vaccine has recently been approved by the State Food and Drug Administration for market approval. It is applicable to women aged 16 to 26 to prevent cervical cancer.
A class of new anti-rheumatoid polypeptide drugs in China has been approved clinically
Recently, AJ1002, a new class of anti-rheumatoid peptide chemical drug jointly developed by China Pharmaceutical University, has undergone extensive and systematic pre-clinical research and development for nearly 8 years. It has recently been approved by the CFDA and allowed to undergo clinical trials. AJ1002 is an innovative drug with China’s independent intellectual property rights and holds a number of international and domestic patents. This variety belongs to a new target and a new mechanism for anti-rheumatoid drugs. Preclinical data show that it is safer and more effective than Adalimumab, which is the world’s first-selling drug.
Six Chinese scientists elected as academicians of the American Academy of Sciences
On May 1, the National Academy of Sciences announced the latest list of academicians of the American Academy of Sciences on the official website, and elected 84 American scientists and 21 foreign scientists in recognition of their outstanding and sustained achievements in original research. Among them, six Chinese scientists including Dan Yang, Fu Yanhui, Gao Huajian, Lin Haifan, Wen Xiaogang, and Zhang Feng were elected as members of the new American Academy of Sciences.
Sanofi PD-1 is expected to be available this year
On May 1st, Sanofi and Regeneron Pharmaceuticals announced that the US FDA has agreed to give priority to the review of its new drug cemiplimab’s biologics licensing application for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) not suitable for surgery or locally advanced CSCC patients. Cemiplimab is an on-going human monoclonal antibody against the checkpoint inhibitor PD-1, which was approved by the FDA last year as a breakthrough therapy. At present, there are 5 PD-1/PD-L1 inhibitors on the market.
Janssen buys oncolytic virus platform
On May 3, Janssen announced that it will acquire BeneVir Biopharm, a biopharmaceutical company. BeneVir uses its proprietary T-Stealth oncolytic virus platform to design an oncolytic virus that can infect and destroy cancer cells. The BeneVir oncolytic virus platform is based on the T-Stealth technology, overcoming the major obstacle to the clinical success of oncolytic viruses. The T-Stealth oncolytic virus can evade the immune system and destroy cancer cells either directly or through activation of the immune system. Under the terms of the agreement, Janssen will pay up to $140 million in prepayments and pay up to $900 million in additional payments when certain scheduled milestones are reached. If all milestones are met, the total amount paid will exceed $1 billion.
Novartis CAR-T Therapy Approved New Indications
Recently, Novartis announced that its CAR-T therapy Kymriah (CTL019) received FDA approval for adult patients with relapsed or refractory large B-cell lymphoma (previously received two or more systemic treatments), including the most common The non-Hodgkin’s lymphoma form – diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma and DLBCL resulting from follicular lymphoma (FL). Kymriah was previously approved by the FDA in August 2017 for the treatment of patients with acute lymphoblastic leukemia (ALL) with B-cell precursors who are refractory to the disease or who have experienced recurrences of secondary and/or more than 25 years of age. Kymriah’s first-quarter sales were 12 million U.S. dollars
FDA Rejects Rumectin Rituximab Bioanalogue
Sandoz recently announced that it has received a complete response from the FDA regarding its refusal to approve its product GP2013, which is a biosimilar drug developed by the company for rituximab. Following the approval of the biosimilar drug in Europe in June 2017, Sandoz filed a GP2013 BLA application in the United States in September 2017. In Europe, the company markets GP2013 under the trade name of Rixathon. The company’s goal is to cover all indications of the original drug approval, including: follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis (RA), granulomatous Vasculitis and microscopic polyangiitis.
Novartis Rac monoclonal antibody approved for listing in China
Recently, Novartis announced that ranibizumab was approved by the State Food and Drug Administration for the treatment of vision caused by macular edema secondary to retinal vein occlusion (RVO), including branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Damage has made it the only anti-VEGF drug in China with retinal vein occlusion indications. The results of the two phase III studies Blossom and Camellia conducted in the Chinese population show that Chinese RVO-ME patients treated with the standardized 3+PRN regimen can achieve significant visual improvement within one week, and the rapid vision they bring Benefits of improvement can last up to four years.