Phase 2 study of pembrolizumab (Pemb) plus plinabulin (Plin) and docetaxel (Doc) for patients with metastatic NSCLC after failure onfirst-line immune checkpoint inhibitor alone or combination therapy: updated efficacy and safety results on immune re-sensitization

Dr. Huang brings over 20 years of entrepreneurial experience in the Chinese and U.S. biotechnology industries. In 2010, Dr. Huang founded Wanchun Biotech, the former holding company of BeyondSpring’s U.S. subsidiary. In 2007, Dr. Huang co-founded Wuxi MTLH Biotechnology Co. Ltd., where she served as CEO in 2010 and continues to hold a directorship. The rights related to the development and marketing of the peptide drug in China, which drug Dr. Huang designed while at Wuxi MTLH Biotechnology Co. Ltd., were sold to Shanghai Pharmaceutical Co., Ltd. in 2010. Additionally, in 2008, Dr. Huang co-founded Paramax International Inc., a CRO that conducts clinical trials for global biopharmaceutical and medical device companies. Paramax International Inc. was acquired by ReSearch Pharmaceutical Services, Inc. in 2009. Dr. Huang was trained at Memorial Sloan Kettering Cancer Center from 1998 to 2002, where her research in cancer signaling pathways involving p53 degradation was published in Science. Her translational research in cancer signaling pathways involving RAS was published in two Nature papers. She has invented and holds patents for a number of biotech products for oncology and dermatology indications.

Dr. Huang received her B.A., Magna Cum Laude and Phi Beta Kappa, from Lawrence University, where she served as a trustee from 2012 to 2015. She received her Ph.D. in chemistry from the University of California at Berkeley, where she won the international-level Women’s Opportunity Award given by Soroptimist International. She also studied at Fudan University in Shanghai, China.

Dr. Lu had ~25 years of industry experience in innovative drug research and development from discovery to clinical studies. She is an accomplished professional in scientific, translational and strategic analysis aspects of R&D projects and pipeline assets. Her special expertise is in multidisciplinary, collaborative leadership experience in the biotech and pharmaceutical industry. Prior to BeyondSpring, she worked at Endocyte, which developed 177Lu-PSMA-617, now approved drug Pluvicto®, and at Advanced Accelerator Applications, a Novartis company, and Novartis Institute for Biomedical Research.

Dr. Lu has led cross-functional project teams to develop small molecule-based strategies for cancer (FolateImmune; bispecific CAR-T cell therapy) and autoimmunity (DHFR/mTOR inhibitors). In addition, she has spearheaded deep-dive scientific efforts in macrophage-targeting, drug resistance & IO (PD 1/CTLA-4) combinations, target ID/pre-validation and indication selections. She has authored 30+ peer-reviewed publications and is an inventor of multiple patents in diverse disease areas.

Dr. June Lu received her Ph.D. in chemistry (biochemistry division) from Purdue University under the mentorship of Dr. Philip Low (co-founder of Endocyte and other biotech companies) and B.S. degree in analytical chemistry from Zhejiang University of Technology.

Dr. John Mao brings over 30 years of leadership experience in biotechnology and pharmaceutical development to his role as Senior Vice President of Development. He has extensive expertise across preclinical and clinical research, regulatory strategy, and global product development, and has successfully advanced novel therapeutics across multiple therapeutic areas including oncology, antiviral, cardiovascular, autoimmune, metabolic, and neuromuscular diseases.

Dr. Mao has managed and executed large-scale development programs spanning CMC, preclinical, and clinical disciplines from early-stage research through regulatory approval, including NDA and MAA submissions. He has contributed to more than 20 INDs, three NDAs, and one MAA, and has engaged extensively with global health authorities such as the FDA, EMA, BfArM, NMPA, PMDA, MFDS, and TFDA.

Prior to joining BeyondSpring Pharmaceuticals, Dr. Mao held senior leadership positions at several biotechnology companies, including Senior Vice President and Head of Development at Foresee Pharmaceuticals, Vice President of Nonclinical Development at Cytokinetics, and Executive/Senior Director at Praecis Pharmaceuticals and Idenix Pharmaceuticals.

Dr. Mao earned his B.S. in Chemistry from Fudan University and his M.S. and Ph.D. in Bioanalytical Chemistry from the University of Rhode Island.

Dr. Li has over 20 years of global clinical development experience in the pharmaceutical industry. She has extensive drug development experience spanning from early-phase clinical trials, regulatory submission for NDA, and pharmacovigilance. Her expertise includes collaborating with and leading multidisciplinary teams in the design and execution of pivotal clinical trials, with a strong focus on data-driven strategies to ensure successful regulatory submissions. Since joining BeyondSpring in 2017, Dr. Li is instrumental in the development of Plinabulin for the treatment of NSCLC with development programs aligned with scientific excellence and regulatory expectations. With increasing leadership roles in clinical science and pharmacovigilance, she oversees the medical safety and statistical analysis required for the development of robust and data-driven strategies.

Prior to BeyondSpring, Dr. Li worked at Sanofi-Aventis and Roche, where she collaborated with multiple functional teams and contributed to scientific advances in oncology and Neurology with NDA approvals. She helped establish a comprehensive process integrating medical, safety, regulatory, and scientific expertise to ensure the highest standards in trial oversight and data analysis. This process was crucial in generating robust data package for submission, supporting multiple FDA/EMA approvals, including Docetaxel (Taxotere®), Cabazitaxel (Jevtana®), and Teriflunomide (Aubagio®).

Dr. Li received her medical degree from Anhui Medical University, China and her Master in Epidemiology from State University of New York at Binghamton, NY.

Mr. Zhang has worked at BeyondSpring for almost a decade with increasing responsibility. He brings a disciplined, detail-oriented approach to advancing complex global drug development programs in CMC. He currently leads global supply chain, manufacturing, and CMC operations across the full clinical development lifecycle of Plinabulin, from pre-IND through Phase III and NDA submission. He is responsible for clinical batch manufacturing under cGMP, global clinical supply continuity, overseeing packaging, labeling, distribution, vendor qualification, and inventory management, and supporting CMC regulatory filings including INDs, IMPDs, and NDA submissions across the U.S., China, and other regions. Hao works cross-functionally with Quality, Regulatory, Clinical, Finance, and external partners to align timelines, budgets, and operational execution. Mr. Zhang holds a master’s degree in chemical engineering from Stevens Institute of Technology and a bachelor’s degree from Southeast University.

Ms Jia has worked at BeyondSpring for a decade and now is the VP of Finance at BeyondSpring, where she leads key finance, accounting, and capital markets activities across the organization. Her responsibility includes SEC reporting for a NASDAQ-listed company, SOX compliance, internal control, audits, finance support in equity financing and strategic transactions. Prior to her current role, Ms. Jia held progressive finance leadership positions at BeyondSpring and its China affiliate, where she managed global accounting operations, cross-border financial coordination, and regulatory compliance across multiple jurisdictions. Earlier in her career, she worked in international finance roles at Miller Electric, gaining experience in global financial operations. Ms. Jia holds a B.A. in Economics from Lawrence University, and she studied at Liaoning University, majoring in Statistics.

Dr. Qi Liu brings over 20 years of global oncology clinical development experience across academia and industry, with deep expertise designing and executing Phase I – III clinical trials and evaluating oncology assets across development stages. Her background spans small molecules, biologics, immunotherapy, and novel therapeutic modalities, reflecting a strong scientific foundation and long-standing commitment to advancing innovative cancer therapies.

Dr. Liu currently advises biotechnology companies focused on cutting-edge oncology approaches, including immunotherapies, bispecific antibodies, ADCs, targeted small molecules, protein degraders, and radiopharmaceuticals. She provides strategic guidance across development strategy, product differentiation, partnering, and regulatory pathways, including IND, NDA, orphan drug designation, and breakthrough designation. Previously, she served as Chief Medical Officer of Elucida Oncology, where she helped define the C-dot development strategy and led IND readiness. Before that, Dr. Liu was CMO of Oncology at Zai Lab, where she built the early oncology portfolio and clinical organization, led global clinical and regulatory strategy, and was a core member of the team that took Zai Lab public on NASDAQ in 2017. Earlier in her career, she held senior leadership roles at AstraZeneca, including Executive Medical Director for Oncology Global Development, where she led Phase I–III programs across multiple tumor types, supported global business development and licensing activities, and helped establish biologics joint ventures.

Dr. Liu earned her M.D. from Shanghai Medical College of Fudan University and her Ph.D. in Molecular Genetics from the University of Georgia. She completed postdoctoral training at Memorial Sloan Kettering Cancer Center, internal medicine residency at Albert Einstein College of Medicine, and medical oncology and hematology fellowship at MD Anderson Cancer Center. She is board-certified in Internal Medicine, Medical Oncology, and Hematology.

Mr. Xu has been an accomplished financial executive for almost thirty years in China.  His most recent role since 2014 is CFO and board member of BOJI Health Investment Management (Shanghai) Co., Ltd. Prior engagements include CFO of Henan Plastic Surgery Hospital, CFO  of Shanghai BOJI Hospital Investment Management Co., Ltd., CFO of Henan Zhiyi Investment Management Co., Ltd., and Director of Finance of Luoyang Chundu Group.  As a financial advisor and strategic investor, Mr. Xu has participated in pre-IPO, IPO, and major asset restructuring for dozens of public companies in China and Hong Kong, such as Henan Taloph Pharmaceutical Stock Co., Ltd. (~$533 M market cap), and Henan Lingrui Pharmaceutical Co., Ltd. (~$1.10 B market cap), Xinxiang Chemical Fiber Co. Ltd. (~$832 M market cap), Central China Land Media Co. Ltd. (~$1.13 B market cap), and China Molybdenum Co., Ltd. (~$17.2 B market cap).

Mr. Xu received his MBA degree from Renmin University in China, and bachelor’s degree from Henan University of Economics and Law in China, with a major in Financial Accounting. He is experienced with China GAAP.

Dr. Majeti is an investor, biotech company advisor, and executive with more than twenty years of experience in the biotech and pharmaceutical industry. She carried out diverse roles with increasing responsibilities in both biotech and large multinational companies, encompassing cross-functional experiences in R&D, business development, supplier management, and outsourcing in the biopharmaceutical industry.   Most recently she was the Head of Global Collaborations and General Manager, China of Erasca, a NASDAQ traded company, managing global collaboration and overseeing CROs to increase productivity and minimize costs. Prior to that, she was Global Category Leader for Roche External Alliance, Senior Director of Business Development for BioDuro, and Senior Scientist at Amgen.

Dr. Majetic is the past president and currently serving on the board of directors of the Chinese-American Biopharmaceutical Society (CABS), a 3000+ member non-profit organization focused on building a stronger community among biopharmaceutical professionals in the US and China.  She is also a member of the BayHelix Group, a non-profit professional organization of business leaders with a mission to shape the growth of the life sciences and healthcare industry globally with a strong presence in China and the US.

Her Ph.D. degree in Molecular Genetics was from the University of Wisconsin at Madison, US, and obtained her postdoctoral training at the Howard Hughes Medical Institute of the University of California, San Francisco. She also earned an M.B.A. degree from the Leavey School of Business at Santa Clara University, graduating as a member of the Beta Gamma Sigma Honor Society.  She completed her undergraduate studies in Biochemistry at Fudan University in China.

Mr. Kirkby has served on our board since October 13, 2016 and brings over 20 years of banking experience to our board. He has held senior management positions in London, Hong Kong and Singapore. From 2015 to 2016 Mr. Kirkby served as Head of Corporate Banking Asia Pacific for HSBC in Hong Kong. From 2012 to 2015 Mr. Kirkby was the CEO North Asia and Co-Head of Investment Banking for CIMB in Hong Kong. He served as Managing Director, Global Head of ECM and Corporate Finance from 2008 to 2010 and Managing Director, Head of Global Banking Asia Pacific from 2010 to 2012 at the Royal Bank of Scotland. Between 1999 and 2007 Mr. Kirkby held various positions at ABN AMRO. He is currently a director or adviser to a number of privately held companies.

He received his M.A. in jurisprudence at Pembroke College, University of Oxford in the United Kingdom.

Mr. Fabbio has served on our board since January 2, 2018.

Mr. Fabbio is currently the Chief Financial Officer of Rafael Holdings, Inc. Mr. Fabbio has more than 25 years of financial, operational and transactional leadership experience in both publicly-traded and privately-held life science and pharmaceutical companies. Prior to joining Rafael Holdings, Mr. Fabbio was Chief Financial Officer of WindMIL Therapeutics Inc. Previously he served as the Chief Financial Officer of Progenics Pharmaceuticals, Inc., electroCore Medical, LLC; Vice President of Finance at NPS Pharmaceuticals, Inc.; Vice President of Finance, Innovation and Growth at Catalent Pharma Solutions Inc.; and Chief Financial Officer at Ikano Therapeutics. His other prior financial positions include roles at Sanofi, UniPath Diagnostics, BioMatrix and Coopers & Lybrand.

He received his B.B.A. in accounting at Pace University and MBA from the Stern School of Business at New York University.

Mr. Delaney brings more than 25 years of global product strategy and launch experience to his role leading commercial organizations. Currently he serves as the Chief Commercial Officer of Constellation Pharma starting in January 2021. Constellation was recently acquired by MorphoSys for $1.4B.

Prior to joining Constellation, Mr. Delaney was the Chief Commercial Officer at Immunomedics, where he led the buildout of the marketing, sales, market access and commercial operations teams. He was instrumental in successfully launching Trodelvy, the first TROP-2 directed antibody-drug conjugate for the treatment of triple-negative breast cancer. Immunomedics was acquired by Gilead Sciences for $21B in September 2020.

Previously, he served as Vice President of U.S. Hematology-Oncology at Celgene Corporation. Prior to joining Celgene, he held various commercial roles at both Novartis Oncology and Genentech, where he led several successful product launches for blockbuster brands.
He earned an MBA from the Stern School of Business at New York University and a B.A. in biology from Rutgers University.

Dr. Feinstein is the recipient of numerous honors and awards, including the Thomas O’Toole Award for his outstanding work with the underserved populations; a Sanofi-Aventis Grant; and the Amgen Fellowship Award. Dr. Feinstein has authored over 50 peer-reviewed articles, abstracts and manuscripts in Hematology and Oncology. He has given international lectures on the treatment of lung cancer, including a proffered paper at ESMO (European Society for Medical Oncology) and leading the AstraZeneca Lung Cancer Summit in Beijing.

Dr. Feinstein co-runs Piedmont Cancer’s research department. He sits on the Piedmont Hospital’s Oncology Scientific Review Committee and is director of research at Piedmont Fayette Hospital. He is a member of Georgia CORE’s research committee along with Georgia Society for Clinical Oncology Clinical Practice Committee. He also chairs the Lung Disease Group for the entire OneOncology network.

Dr. Lin is a Professor and Physician Scientist, with joint appointments in the Departments of Radiation Oncology and Experimental Radiation Oncology. Dr. Lin’s practice focuses on thoracic malignancies, and he oversees several clinical trials including the use of proton beam therapy for esophageal cancer and in the combination of immunotherapy with radiotherapy in lung and esophageal cancers.

Dr. Lin runs a translational research team that evaluates biomarkers for treatment response and disease outcomes after chemoradiation therapy and immunotherapy. On the basic science side, Dr. Lin’s main interests lie in identifying novel approaches that could enhance radiotherapy and immunotherapy combinations in lung cancer that could be translated to innovative clinical trials for patients.

Dr. Ruckdeschel is a Professor at the Fox Chase Cancer Center in Philadelphia and a Board Member of the Philadelphia American Cancer Society. Previously he was Director of the University of Mississippi Cancer Center and Research Institute in Jackson, Mississippi, and the Ergon Chair in Cancer Research. He retired in 2020 but failed retirement and returned to Fox Chase in 2024. He trained at Johns Hopkins, Harvard and the National Cancer Institute and then first joined the faculty at Albany Medical College.  From there he went on to become the first CEO at the Moffitt Cancer Center in Tampa, leading them to NCI Comprehensive designation and a top 10 designation in US News and World Report. He then served as CEO of the Karmanos Cancer Institute in Detroit and the Nevada Cancer Institute in Las Vegas. He served as Director of the Oncology Program at Intermountain Healthcare before moving to Mississippi in 2017 

His research focus has been on the areas of lung cancer and patient-physician communication resulting in over 200 peer-reviewed publications.  He served as a member of the ECOG Thoracic Committee for 27 years and headed it in the mid 1980’s. He was the Executive Officer of the Lung Cancer Study Group and co-chaired the NCI’s Progress Review Group on Lung Cancer.  He currently serves as a Sign Off Editor for Cochrane Reviews, an Associate editor of British Medical Journal Case Reports and was a member of the Prevention and Screening Committee of the International Association for the Study of Lung Cancer. 

Dr. Grippin is a physician-scientist at the University of Texas MD Anderson Cancer Center. Dr. Grippin completed his M.D. and Ph.D. in Biomedical Engineering at the University of Florida, where he was inducted into the UF Hall of Fame for his leadership and research achievements. During his training, he contributed to development of a personalized mRNA vaccine that is now in first-in-human clinical trials for patients with brain tumors. His translational research program now focuses on harnessing RNA-based therapeutics to enhance immune checkpoint blockade. These efforts have resulted in first-author and co-authored publications in high-impact journals, including Nature, Cell, Nature Biomedical Engineering, Nature Reviews Immunology, Nature Cancer, Nature Communications, Clinical Cancer Research, Cancer Research, NanoLetters, and ACS Nano. Dr. Grippin received widespread recognition from his recent featured article in Nature  (Grippin AJ et al. “SARS-CoV-2 mRNA vaccines sensitize tumors to immune checkpoint blockade” Nature. October 22, 2025). This paper has garnered significant attention and in a single week became one of the most discussed papers of all time, being featured in over 550 media outlets with an Altmetric Score in the top 0.0002% of all research outputs. These findings have led to planning of a Phase III clinical trial in which Dr. Grippin will be the national Co-Chair. This research also provides the foundation for Dr. Grippin’s effort toward developing more effective universal, “off-the-shelf” dendritic cell activating therapeutics that can be easily manufactured and disseminated globally to significantly improve cancer patient outcomes.