Product Pipeline

Delova Biotech focuses on the unmet medical needs in the field of pain in both China and U.S. The Company has laid out nearly 10 new non-opioid analgesics, which have sequentially entered the clinical development stage. The Company has also applied for nearly 20 key patents.

Project Mechanism Indication Country Preclinical IND Phase Ⅰ Phase Ⅱ Phase Ⅲ NDA
Project QP001
Mechanism NSAIDS
Indication Postoperative pain
Country
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
  • 临床前
    IND
    Phase Ⅰ
    Phase Ⅱ
    Phase Ⅲ
    NDA
  • 临床前
    IND
    Phase Ⅰ
    Phase Ⅱ
    Phase Ⅲ
    NDA
QP001 is the first new long-acting post-operative analgesic drug independently developed by Delova Biotech, which is a new NSAID injection with a COX-2 mechanism. Its 24-hour long-acting strong analgesic ability and low incidence of adverse reactions can fill the gap of long-acting NSAID injection in China, with significant clinical advantages compared with existing treatments.

Domestic Phase I and Phase II clinical studies of QP001 have been completed, and the Phase III clinical trial is ongoing. The Company is expected to submit a domestic New Drug Application (NDA) of QP001 in the third quarter of 2023.

In addition, the Company has completed the pivotal clinical study of QP001 for the U.S. NDA and successfully met the primary study endpoint. A pre-NDA meeting was held with the FDA on August 18, 2022, and several agreements were reached, and an NDA for QP001 is expected to be submitted to the FDA in the coming months.

QP001 is expected to be the first new drug marketed simultaneously in China and the U.S. by Delova, and also the first new analgesic drug in China to "go abroad to the United States".
Project QP002
Mechanism Local paralysis
Indication Postoperative pain
Country
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
  • 临床前
    IND
    Phase Ⅰ
    Phase Ⅱ
    Phase Ⅲ
    NDA
  • 临床前
    IND
    Phase Ⅰ
    Phase Ⅱ
    Phase Ⅲ
    NDA
QP002 is the second new long-acting postoperative analgesic drug independently developed by Delova Biotech, based on XisGel® patented extended-release technology platform. It is the first new drug for postoperative analgesia that can be administered by instillation in China, providing long-lasting analgesia for more than 72h with a single dose. Compared with similar drugs globally, QP002 has the advantages of higher drug loading capacity, smaller drug delivery volume, greatly enhanced clinical convenience, and lower cost.

Till now, the Company officially received the domestic drug clinical trial approval notice for QP002 on July 29, 2022.
Project
Indication
Preclinical
IND
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
NDA
QP001
Postoperative pain
QP002
术后疼痛
Other pipeline products are to be disclosed.