The first domestic long-acting analgesic new drug developed by Qingpu Biotechnology, a direct-investment enterprise of the Venture Capital Group, has been approved for marketing

On May 9, the website of the National Medical Products Administration (NMPA) showed that Meloxicam Injection (QP001), developed by Nanjing Qingpu Biotechnology Co., Ltd. (hereinafter referred to as "Qingpu Biotechnology") — a direct-investment enterprise of the Venture Capital Group — has been approved for marketing. This is the first domestic long-acting analgesic new drug, and a single injection can achieve 24-hour continuous and potent analgesia.

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Injection QP001 is developed based on the poorly soluble drug solubilization technology platform (SimSol™) with independent intellectual property rights owned by Qingpu Biotechnology, and it is the first product in the company’s non-opioid analgesic new drug pipeline. Currently, this product has been submitted for marketing approval in the United States and can be used to relieve various types of acute pain, especially suitable for post-operative pain. Compared with existing drugs of the same class, QP001 has significant advantages in analgesic potency, safety, and duration of analgesic effect.

The approval of this drug is based on the excellent results of its two confirmatory Phase III clinical trials, where all primary and secondary endpoints achieved statistically significant differences. These results confirm that QP001 can maintain potent analgesic effects within 24 hours, and its analgesic potency and safety are both superior to drugs of the same class. Compared with the clinical trial data disclosed in the package inserts of other marketed non-steroidal anti-inflammatory drugs (NSAIDs) of the same class, QP001 has the highest proportion of morphine dosage reduction, and has the potential to become the NSAID with the strongest analgesic effect.

In December 2022, the Direct Investment Department of the Venture Capital Group invested in Qingpu Biotechnology through the Sci-Tech Innovation Fund, and then provided additional investment support to Qingpu Biotechnology via the Phase II Municipal Talent Fund in March 2023.

Yan Peng'an, General Manager of the Investment Department III of the Venture Capital Group, stated: "We warmly congratulate Qingpu Biotechnology on the approval of Meloxicam Injection (QP001) for marketing. Currently, the number of surgeries in China continues to grow, and there is a significant gap between the demand for post-operative analgesia and effective supply. As the only Meloxicam Injection classified as a National Class 2 New Drug in China, it fills the market gap for long-acting non-opioid analgesics. From the perspective of clinical data, QP001 is developed based on the SimSol™ technology platform. It exerts analgesic and anti-inflammatory effects by precisely targeting COX-2, with minimal impact on COX-1, which reduces the incidence of adverse reactions such as gastrointestinal disorders and platelet inhibition. It can achieve long-acting analgesia within a half-life of 18-22 hours. Results from two Phase III clinical studies show that its efficacy in terms of 24-hour analgesic effect and safety is superior to that of similar products. This approval is an important milestone in the development of Qingpu Biotechnology. We look forward to Qingpu Biotechnology taking this as a starting point, continuing to innovate, and benefiting patients with more breakthrough achievements."

Source: Yan Peng'an from Investment Department III

Review: Xue Yao

Release: You Yi