Jul 01, 2020
SHANGHAI, CHINA and PHILADELPHIA, U.S. July 1, 2020 — Antengene Corporation today announced its appointment of Zhinuan Yu, Ph.D., as Corporate Vice President (CVP) of Biometrics and Regulatory Enabling Functions. Zhinuan will be responsible for providing statistical leadership and strategic regulatory input on company pipeline projects and will report directly to Dr. Jay Mei, Chairman and CEO of Antengene.
Dr. Zhinuan Yu has been working in the pharmaceutical industry for more than 20 years. Prior to joining Antengene, she was Senior Director of Biostatistics at Bristol-Myers Squibb Company. Before that, Zhinuan had served in Celgene Corporation for nearly 16 years, leading statistical support for multiple high priority programs including Thalidomide, Lenalidomide, Pomalidomide, and bb2121 (CAR-T) for multiple myeloma and other therapeutic areas, and played a key role in successful NDA/sNDA/BLA submissions with global health authorities including the US FDA, EMA, Swissmedic, Health Canada, PMDA, CFDA, and other regulatory agencies.
Dr. Zhinuan YU
Zhinuan provided statistical expertise and co-authored multiple publications in prestigious journals including the New England Journal of Medicine (NEJM) and Lancet, and at various professional conferences. Her outstanding contributions and leadership earned her the highest individual recognition bestowed by Celgene, the John W. Jackson Leadership Award. Prior to Celgene, Zhinuan had worked at Organon (now Merck) and the University of Miami.
“I'm delighted to have Zhinuan join Antengene at this exciting time. Zhinuan will play a key role inbuilding Biometrics and Regulatory Enabling Functions with her solid technical knowledge of advanced statistical methodologies as well as successful experience in NDA/sNDA submissions," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. “We have initiated NDA of ATG-010 (selinexor) for the patients with relapsed refractory multiple myeloma (RRMM) and the patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) with several Asia Pacific markets that meet the regulatory requirement. I am confident that Zhinuan, a seasoned industry leader with a proven track record in the past 20 years in NDA with global regulatory agencies, will strengthen our ability to deliver meaningful results now and in the future.”
“I am impressed by the fast growth of the promising pipeline and talented team at Antengene within such a short time,” said Zhinuan. “Having had an amazing journey of drug development at Celgene/BMS, I look forward to joining Jay and the Antengene team to continue to do well by doing good, and to bring much needed innovative medicines to patients in China, Asia Pacific regions, and around the globe.”
Zhinuan earned her B.A. in English and M.A. in World Economy from Fudan University in China, and Ph.D. in Psychometrics/Statistics from Tulane University in the USA.
Antengene is a biopharmaceutical company with integrated drug discovery, clinical development, manufacturing and commercialization anchored in Asia Pacific region with global layout, aiming to provide the most advanced and first-in-class anti-cancer drugs and other treatments for patients in China, the rest of Asia and around the world. In April 2017, Celgene (now officially acquired by Bristol-Myers Squibb, and a world’s top ten pharmaceutical company after the merger), a global leading innovative biopharmaceutical company became a founding partner and obtained an equity position as an investor in Antengene. Over the past 3 years, Antengene has obtained 7 IND approvals with 6 first-in-class drugs in more than 10 ongoing cross-regional clinical trials in Asia Pacific regions, and has built a product pipeline of 12 clinical and pre-clinical stage programs. The vision of Antengene, “Treating Patients Beyond Borders.” is to meet the unmet medical needs of patients in Asia Pacific regions and around the world through research & development and commercialization of first-in-class drugs.
ATG-010 (selinexor) is the first oral selective inhibitor of nuclear export (SINE) compound with novel mechanisms in the world. In July 2019, the U.S. FDA approved selinexor in combination with low-dose dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma. Currently, the registration clinical trials of ATG-010 in relapsed refractory multiple myeloma (RRMM) and diffuse large B-cell lymphoma (DLBCL) are ongoing in China. The compound is also in late clinical development for various other hematologic malignancies and solid tumors. In addition, preclinical studies have shown that inhibitors of nuclear protein export XPO1 can effectively treat KRAS mutant tumor, and related clinical studies are currently being conducted.
ATG-008 is a second-generation dual mTORC1/2 inhibitor and is in multi-regional clinical trials for treatment of advanced liver cancer, lung cancer, and several other tumors.
ATG-016 is a second-generation oral selective inhibitor of nuclear export protein, and is currently being studied in myelodysplastic syndrome (MDS) as well as in several clinical trials of solid tumors, including colorectal cancer (CRC), gastric carcinoma (GC), triple-negative breast cancer (TNBC) and prostate cancer (PrC) .
ATG-019 is the first-in-class PAK4/NAMPT dual-target inhibitors, and is currently being studied in a number of clinical trials including non-Hodgkin's lymphoma (NHL), colorectal cancer, lung cancer, and melanoma. In addition, preclinical studies have demonstrated that ATG-019 in combination with anti-PD-1 antibodies can effectively improve the anti-tumor activity and is effective in tumors that became resistant to anti-PD-1 therapy. Related clinical trial is about to initiate.
ATG-527 is an innovative product under development for antiviral and treatment of autoimmune diseases, and has been in clinical trial of healthy volunteers and been studied against Epstein-Barr virus (EBV), respiratory syncytial virus (RSV) infection, cytomegalovirus (CMV) infection and Systemic lupus erythematosus (SLE) and other related diseases.
ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor, in clinical development for the treatment of various solid tumors, non-Hodgkin's lymphoma, acute myelocytic leukemia (AML) and multiple myeloma.
In addition, the drug discovery team of Antengene focuses on the early preclinical development of multiple innovative target drugs in the fields of small molecule, monoclonal and bi-specific antibodies.
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.