Zhejiang Drug Patent Portfolio

Zhejiang's Family Patents


Family Patents



Recent FDA approvals and tentative approvals for Zhejiang

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


Generic drugs

Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.

Drug Name Submission class (FDA) Submission Category Submission Date
Topiramate ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 29 Jun, 2026


Clinical Trials

Recent Clinical Trials by Zhejiang:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica Zhejiang University NA COMPLETED
(Sep 1, 2026)
PHASE3
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer Second Affiliated Hospital, Zhejiang University, School of Medicine NA RECRUITING
(Sep 1, 2026)
PHASE2
The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery Zhejiang University NA COMPLETED
(Aug 1, 2026)
PHASE2
Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study Zhejiang Cancer Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
VG081821AC Tablets for Early to Mid-stage Parkinson's Disease Zhejiang Vimgreen Pharmaceuticals, Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma Second Affiliated Hospital, Zhejiang University, School of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Bridging Study of XKH001 in Healthy Adult Caucasian Participants Zhejiang Kanova Biopharmaceutical Co., LTD NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer Zhejiang University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Sintilimab Plus Hypofractionated Radiotherapy Followed by Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma Second Affiliated Hospital, Zhejiang University, School of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE2
A Sequential Trial of Low-Dose Radiotherapy Followed by Concurrent Immunotherapy, Systemic Chemotherapy, and Intraperitoneal Perfusion in Gastric Cancer With Peritoneal Carcinomatosis Zhejiang Cancer Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy for Stage II-III HER2-Positive Breast Cancer First Affiliated Hospital of Zhejiang University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Platinum-Free Regimen in Nasopharyngeal Carcinoma Zhejiang Cancer Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Bevacizumab in the Treatment of HHT Second Affiliated Hospital, Zhejiang University, School of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE2
Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Zhejiang Cancer Hospital NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer Second Affiliated Hospital, School of Medicine, Zhejiang University NA RECRUITING
(Jul 1, 2026)
PHASE2
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma Zhejiang Cancer Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer Zhejiang Cancer Hospital NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Elemene Liposomes in Endometrial Cancer Women's Hospital School Of Medicine Zhejiang University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy Second Affiliated Hospital, Zhejiang University, School of Medicine NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1 Zhejiang University NA RECRUITING
(Jun 1, 2026)
PHASE3
Efficacy and Safety of Trifluridine/Tipiracil (TAS-102) Combined With Bevacizumab and Serplulimab in Patients With Metastatic Colorectal Cancer Undergoing Cytoreductive Surgery: A Single-Arm, Single-Center Clinical Study Second Affiliated Hospital, School of Medicine, Zhejiang University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
Healthy Participants Randomized, Double-blind, Placebo-controlled, Phase Ⅰ First Affiliated Hospital of Zhejiang University NA RECRUITING
(Jun 1, 2026)
PHASE1
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia Zhejiang Doer Biologics Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases Zhejiang University NA RECRUITING
(Jun 1, 2026)
PHASE2
CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors. Zhejiang Cancer Hospital NA RECRUITING
(May 1, 2026)
PHASE2
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer Second Affiliated Hospital, School of Medicine, Zhejiang University NA RECRUITING
(May 1, 2026)
PHASE2
Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer Second Affiliated Hospital, School of Medicine, Zhejiang University NA RECRUITING
(May 1, 2026)
PHASE2
QL1706 Combined With Cisplatin/Paclitaxel as Neoadjuvant Therapy for Cervical Cancer Second Affiliated Hospital, School of Medicine, Zhejiang University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR/MSS Gastric Cancer First Affiliated Hospital of Zhejiang University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV First Affiliated Hospital of Zhejiang University NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy First Affiliated Hospital of Zhejiang University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy First Affiliated Hospital of Zhejiang University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma Zhejiang University NA RECRUITING
(Apr 1, 2026)
PHASE2
A Phase Ib/II Study Evaluating Injectable ALK-N001 in Patients With Advanced Solid Tumors Zhejiang Anglikang Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis The Fourth Affiliated Hospital of Zhejiang University School of Medicine NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure Second Affiliated Hospital, School of Medicine, Zhejiang University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
T Cell Receptor Gene-Engineered and Dominant Negative TGF-β Receptor T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor Zhejiang University NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1
IT-TT as an Effective and Well-Tolerated Strategy for CNS Prop in High-Risk DLBCL: a Prospective Ph II Study Zhejiang Cancer Hospital NA COMPLETED
(Mar 1, 2026)
PHASE2
Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection Zhejiang Kanova Biopharmaceutical Co., LTD NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


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