Haixiao Chen

• Build and lead global PV & Safety department (~20) in US and China with Medical Safety and PV Operation & Compliance functions. • Lead medical safety and risk management strategies on all Ascentage’s products in hematological oncology and solid tumors and non-tumor indications in Phase 1-3 global clinical development and post-marketing (PM): o HQP1351 (olverembatinib): Phase 3 clinical development programs for this 3rd generation TKI for CML, Ph+ ALL, and SDH GIST; PM of 耐立克® in China o APG2575 (lisaftoclax): Phase 3 clinical programs for this selective Bcl-2 inhibitor for r/r CLL/SLL, AML, MDS, MM, MCL, ER+/HER2 Breast Cancer, and SLE; PM of 利生妥® in China o APG2449: Phase 1-3 clinical programs of this FAK/ALK/ROS1 inhibitor for NSCLC and other solid tumors (e.g., ovarian cancer) o APG115 (alrizomadlin): Phase 2 clinical programs of this MDM2-p53 inhibitor for Melanoma, ACC, Malignant Peripheral Nerve Sheath Tumor (MPNST), AML, and MDS o APG1252 (pelcitoclax): Phase 2 clinical programs of this Bcl-2/Bcl-xl inhibitor for r/r AML, r/r NHL and NSCLC o APG1387: Phase 2 clinical programs of this IAP/XIAP inhibitor for pancreatic cancer and other solid tumors o APG5918: Phase 1 clinical programs of this selective EED inhibitor for hematological malignancies (e.g., TCL), solid tumors, and Anemia o APG3288: Phase 1 clinical program of this BTK degrader for B-cell hematological malignancies (e.g., r/r CLL/SLL, B-NHL, DLBCL, MCL, MZL, and FL) • Build PV system and SOPs to be pre-NDA inspection ready by FDA, EMA, China and Japan, set up J-ARGUS for PMDA safety reporting (ICSR, J-Alert, J-DSUR), and develop templates to ensure compliance, consistency and efficiency(e.g., dRMP, Global and local RMPs, Safety Signal Assessment Report). • PV vendor oversight to ensure high quality and compliance with global regulations. • Chair Corporate Drug Safety Committee to review significant safety issues that may impact the Benefit-Risk profile of product.

Provide dynamic leadership, strategic direction and governance of drug safety and pharmacovigilance activities across Xenon’s portfolio in Neurological and Psychiatric Disorders in Phase 1-3 Clinical Developments. Build Safety Department with four functional groups: Medical Safety Assessment, Safety Surveillance & Aggregate Safety Report, Pharmacovigilance Operation & Compliance, and Epidemiology. Plan and manage 5-year PV budget. Chair the corporate Safety Advisory Committee. Set up PV SOPs. Lead Safety Strategies in pre-IND meetings, End of Phase II FDA meetings, and pre-NDA meetings, and NDA Submission preparation. Launch readiness. Inspection readiness and CAPA management. PV Vendor oversight. Lead PV strategies in in-license/out-license activities (due diligence, contracting, transition for business development activity). Visionary leader and inspiring mentor.

Lead patient safety and pharmacovigilance activities across Vir’s portfolio (Phase 1-3 Clinical programs: Covid-19, Flu, HBV, HDV, HIV, CMV Vaccines for HIV/HPV/TB; Post-marketing: Xevudy® (sotrovimab for Covid-19)), using a stage appropriate, risk-based approach. Build Global PVRM Department with two functional groups: Medical Safety Assessment and Pharmacovigilance Operation Group. Write safety SOPs and Set up PV system to be inspection ready. Chair Corporate Safety Board. Plan and manage PVRM budget. Inspiring mentor and people manager.

Managed PVRM department including units of Medical Safety Assessment, Risk Management Strategies, PV Operations, PV Systems, Contract/Licensing/Vendor Management, and PV Compliance/Quality/Training. Ensured regulatory compliance for all Pharmacovigilance and Risk Management activity with 98%+ compliance in ICSR reporting (~20,000/year), 100% compliance in SUSAR reporting, Aggregate Safety Reports submissions (~500 PADERs/year), and REMS submissions (~100/year) for 14 Single or Shared REMS Programs (including REMS Assessment Reports, REMS Modifications, REMS Revisions, REMS Periodic Updates, REMS Noncompliance Protocols and Audit Plans, Response to FDA Information Requests, and FDA Communication). Provided strategic, medical and operational expertise regarding the safety and risk assessment of Endo products (35 Branded, 600+ Generics) at all stages of the product lifecycle (phase I-IV and post-marketing). Brought the best industry practice to Endo, enhanced SOPs of Signal Management and Risk Management per FDA / EMA regulations, developed flow chart for signal detection / evaluation, wrote templates for Signal Assessment Report and Rational for Safety Labeling Change, and set up cross-functional SMTs for products under clinical development. Chaired Safety Review Board, the highest corporate safety board, to govern drug safety and patient safety. Promoted diversity, open communication, collegiality and teamwork among peers and cross-functional team members.

Led safety perspective of the largest asset under clinical development at BMS – Sotyktu® (deucravacitinib, TYK2i) Phase I-III clinical programs (adult programs, pediatric programs, extended-release formulation programs, and lifecycle management programs) in 12 indications with 40+ ongoing global clinical studies. SMT Chair responsible for overall safety strategies, benefit-risk assessment, safety signal evaluation & management, and risk management/mitigation strategies (e.g., Early Development Safety Roadmap [EDSR], Company Core Risk Management Document [CCRMD], and Risk Management Plan [RMP]). Provided safety strategies as Global Safety Lead in NDA/MAA simultaneous submissions in US and EU, subsequent submissions in Japan, China, Canada, and Australia within 6 months, and the rest of world (ROW) within 1-2 year.

Strategic and operational leader building PSPV department, leading Medical Safety & Risk Management, PV Operations & Safety System, QA & Compliance, Contracts & Licensing, and Vendors & CROs Management, ensuring regulatory compliance with high quality. Mentor safety physicians and PV scientists as leader of Safety Management Teams (SMT) for signal detection, safety evaluation, benefit risk assessment, SAE management and clinical safety monitoring in phase I-III clinical trials, risk management and safety surveillance for Phase I-III investigational products and marked products, in the therapeutic areas of Infectious Disease, GI, Oncology, Respiratory, Hematology, and Woman Health.

TA Safety Leader for global safety physicians responsible for all safety related issues in projects moving from pre-clinical to First-IN-Human, or investigational products in phase I-III clinical development, or marketed products with or without phase IV PASS studies, in the therapeutic areas of Oncology, CNS/Pain, Woman Health, Cardiovascular & Metabolism. Strategic and effective leader | Safety Management Team | First in Human Committee | IB | protocol | ICF | CRF | CSR | Clinical Safety Monitoring Plan | Data Monitoring Committee | Adjudication Committee | Clinical Overview | ISS | SCS | ISE | SCE | Briefing Books | BLA/ NDA/MAA filings | | FDA Advisory Committee meetings | Oncology Drug Advisory Committee meetings | Post-marketing Requirements | PBRER, PSUR, DSUR, IND AR, NDA AR, RMP, REMS, Medication Guide | Signal Management | CCDS | Labeling | Health Hazard Assessment | Due Diligence | In-licensing | Acquisition | Data Migration | ARISg | MedDRA

Senior Global Pharmacovigilance & Risk Management Physician responsible for safety surveillance for all investigational or marketed products in GI and Woman Health. Influential and cohesive leader | Safety Management Team | Early/late phase clinical development | NDA/MAA submission | CO, ISE, ISS, SCE, SCS | Thorough QT Study | DDI Study | PASS | PAES | Drug Utilization Study (DUS) | Patient Support Program (PSP) | Market Research Study | Pharmaco-epidemiological Study | Registry study | IIT | Malignancy Risk | Cardiovascular Risk | Suicidality/Depression Risk | DB PC cardiovascular safety study | Meta-analysis for cardiovascular outcomes in multiple database studies from CPRD/THIN/ISD/GePaRD | PIP | License Renewal | Joint Safety Review Committee | License Partner | PSUR, PBRER, DSUR, PADER, IND AR, NDA AR, RMP, dRMP | Signal Detection | Signal Evaluation | Medical Safety Assessment Reports | ICSR | Adverse Drug Reactions | Medical Review | SUSAR | ARGUS Safety | MedDRA | Global Health Authority interactions

Senior Global Pharmacovigilance Physician in Drug Safety & Epidemiology responsible for all safety related issues for products marketed or during phase I-IV clinical development in Respiratory, Ophthalmology, Inflammatory and Infectious disease, Neuroscience, Dermatology, and Established Medicines (mature products for all TAs). Collaborative and efficient team player | Safety Management Team | NDA/BLA submission | Global cross-functional and multi-cultural Safety Management Team | Signal Detection | Empirica Signal | Benefit-Risk Assessment | Benefit-Risk Profile | Signal Detection Board | Medical Safety Review Board | Safety Profiling Plan | KOL | TPP | Clinical Development Plan | Protocol | Drug Safety Monitoring Board | IB | CSR | CDS/USPI/SmPC/Local PI update | CO, ISE, ISS, SCE, SCS | Manuscripts | PSUR, US PSR, EU ASR, PSUR addendum report, Summary Bridging Report, RMP, REMS | Dear Doctor Letter | Medical Risk Assessment | Clinical Safety Expert Statement | ICSR Medical Review | SUSAR | Similar Event Analysis | Investigator Notification ARGUS Safety | MedDRA | Global Health Authority interactions (FDA, EMA, PMDA, NMPA/CFDA, and Rest of World)

• Principle Program statistician responsible for statistical perspectives for global clinical programs in Respiratory, Inflammation & Infectious Disease, and Dermatology. • Led statistical aspects in BLA/NDA/MAA submissions with global approvals. Wrote master statistical analysis plan (MSAP), pooling strategies, and statistical sections in SCE and SCS. • Participated in advisory committee meetings, pre-NDA/BLA submission meetings, meetings for phase IV post-approval commitments with FDA, EMA, PMDA, CFDA, and Rest of World (ROW). Wrote statistical method and analysis of briefing books. Discussed strategies of data presentation to HAs with clinical team and regulatory affair.

• Developed clinical measures with clinicians to evaluate the performance of over 18,000 health care organizations, and implemented the statistical methodologies in the ORYX initiative. • Provided guidelines to more than 200 performance measurement systems participating in the ORYX initiative. • Generated quarterly reports and maintained the database collected over 18,000 health care organizations