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Recent FDA approvals and tentative approvals for Qilu

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
Nintedanib ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 17 Mar, 2026
Abemaciclib ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 06 Nov, 2025
Lasmiditan ORIG-1
ⓘ
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 20 Dec, 2024


Clinical Trials

Recent Clinical Trials by Qilu:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration Qilu Pharmaceutical (Hainan) Co., Ltd. NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study Qilu Hospital of Shandong University NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Phase II Study of QLC2519 in Pediatric Solid Tumor Participants Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Jul 1, 2026)
PHASE2
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE2
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
QLC5508 in Participants With Metastatic Prostate Cancer Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC/GEJ Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy Qilu Hospital of Shandong University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3
QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
QLS5132 Combination Therapy in Advanced Solid Tumors Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


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