On May 16, there was more good news for Meloxicam Injection (II), a non-opioid analgesic new drug for which Sino Biopharm (1177.HK) holds exclusive commercialization rights in Chinese mainland. Recently, the New Drug Application (NDA) for this product was formally approved by both the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA). In China, it was approved as a Class 2.2 new chemical drug for the management of post-operative pain in adults, becoming China's first once-daily, 24-hour long-acting non-steroidal anti-inflammatory drug (NSAID) injection. It is also the first analgesic new drug from China to receive FDA approval and the world's only commercially available long-acting NSAID injection.

 

This product (Chinese generic name: Meloxicam Injection (II), Chinese brand name: Putanning™, U.S. brand name: QAMZOVA™, project code: QP001) is expected to succeed Flurbiprofen Axetil Injection (brand name: Kaifen^®) and become the next blockbuster product for Sino Biopharm in the field of analgesia. The company will leverage its strong commercialization capabilities to fully enhance drug accessibility and benefit more patients suffering from pain.

 

China's First Once-Daily, 24-Hour Long-Acting Analgesic NSAID Injection

 

Putanning™ was developed by Nanjing Delova Biotech Co., Ltd. (Delova Biotech). To date, under the new domestic registration classification, it is the only approved Class 2.2 new drug for post-operative analgesia and the only approved new NSAID drug. As the world's first new-generation "solution-type" high-concentration meloxicam long-acting intravenous injection, Putanning™ allows for once-daily administration, providing 24 hours of continuous, potent analgesia and significantly improving medication adherence.

 

Post-operative pain is one of the most common types of acute pain in clinical practice. If not properly managed, it can develop into chronic post-surgical pain (CPSP), severely affecting patients' quality of life and post-operative recovery. According to statistics, the incidence of post-operative pain in hospitalized surgical patients is as high as 91.8%, with 79.1% of these patients experiencing moderate, severe, or extremely severe pain^[1]. In 2022, the number of surgical procedures for hospitalized patients in China exceeded 82 million, yet inadequate analgesia remains a common problem^[2]. The rate of effective pain relief in Grade IIIA hospitals is only about 30%^[3], indicating a huge unmet need.

 

Currently, injectable drugs commonly used for post-operative analgesia in China require multiple injections per day or continuous administration through an indwelling catheter^[4-5]. In two Phase III clinical studies, Putanning™ was confirmed to provide 24 hours of continuous, potent analgesia with a single injection. It was particularly demonstrated to maintain a significant analgesic effect even at the end of the dosing interval (i.e., 18-24 hours)^[7-8]. This can effectively address post-discharge pain and pain between doses, especially nocturnal pain during post-operative hospitalization, significantly improving patient and healthcare provider adherence. At the same time, compared to currently common clinical NSAID injections, Putanning™ can also be used normally in special populations common in surgery, such as patients with mild renal impairment and elderly patients, demonstrating excellent safety.

 

Outstanding Potent Analgesic Performance, the First Domestically Produced Analgesic New Drug to Receive FDA Marketing Approval

 

In terms of international performance, this product is not only the first domestically produced analgesic new drug to receive FDA marketing approval but also one of the very few domestic new drugs to be granted "Application Fee Waivers" by the FDA.

 

Opioid analgesics have caused a global crisis due to their addictive nature. Multiple guidelines, including the American Society of Anesthesiologists (ASA) "Guidelines for the Management of Acute Perioperative Pain", the ERAS Society "Guidelines for Postoperative Pain Management", and the International Association for the Study of Pain (IASP) "Expert Consensus on Postoperative Pain Management", all explicitly recommend multimodal analgesia to replace or reduce the use of opioid analgesics. The U.S. Congress has even passed the "Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act", which aims to reduce opioid dependence through adjustments in healthcare insurance policies and promote the widespread use of non-opioid painkillers.

 

Compared to the package inserts of similar marketed NSAIDs, Putanning™ has the highest percentage reduction in morphine use, demonstrating outstanding analgesic effects. Results from two Phase III clinical trials showed that Putanning™ can significantly reduce morphine consumption and pain scores in subjects after orthopedic and abdominal surgeries. In the orthopedic surgery study, Putanning™ reduced morphine consumption by 56.3% over the entire study period (within 48 hours)^[7]; in the abdominal surgery study, Putanning™ reduced morphine consumption by 46.0% over the entire study period (within 48 hours)^[8].

 

Innovative Preparation Technology Creates a New Generation of Global Long-Acting Analgesic Injections

 

Furthermore, as a new-generation "solution-type" high-concentration meloxicam long-acting intravenous injection, Putanning™, through breakthrough innovations in formulation technology, achieves high-concentration, long-acting analgesia and possesses excellent formulation characteristics such as being a "clear and transparent solution", tolerance to terminal sterilization, and excipient safety.

 

The core invention patent for Putanning™ has entered multiple countries globally via the Patent Cooperation Treaty (PCT) route and has been formally recognized and granted in several countries, including China, the United States, and Japan.

 

Surgery/Analgesic is one of the four major strategic areas for Sino Biopharm, with core departments including anesthesiology, orthopedics, surgery, and pain management. Currently marketed blockbuster analgesic products also include Flurbiprofen Cataplasm, Flurbiprofen Axetil Injection, Lidocaine Cataplasm, and Limaprost Alfadex Tablets.

References:

[1] Haroutiunian S,Nikolajsen L,Finnerup N B,et al.The neuropathic component in persistent postsurgical pain: a systematic literature review[J].Pain,2013,154(1):95-102.

[2] Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL.Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey.Curr Med Res Opin.2014 Jan;30(1):149-60.

[3] China Health Statistics Yearbook 2023

[4] Chinese Society of Anesthesiology, Chinese Medical Association. Expert consensus on management of artificial intelligent patient-controlled analgesia [J]. Chinese Journal of Anesthesiology, 2022, 42 (1): 1-6.

[5] Chinese Association of Anesthesiologists, Chinese Medical Doctor Association. Guidelines for the management of acute perioperative pain [J]. National Medical Journal of China, 2020, 100 (12): 881-888.

[6] Junlong M, Jie H. et al.A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Novel Intravenous Formulation of Meloxicam (QP001) in Healthy Chinese Subjects.Drug Design, Development and Therapy 2023:17 2303–2313.

[7] Zhou, Y., Jiang, Y., Duan, K. et al.Efficacy and safety of 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1,1-dioxide, a rapid-acting meloxicam formulation, for analgesia after orthopaedic surgery under general anaesthesia: a randomized controlled trial.Inflammopharmacol 32, 2024,3799–3808 .

[8] Xiaohua L, Yanhua Z.et al.Efficacy and safety of 4-hydroxy 2-methyl-N-(5-methyl-2-thiazolyl)-2H-1, 2-benzothiazin-3-carboxamide 1,1-dioxide, a fast-acting meloxicam formulation, on moderate-to-severe pain following abdominal surgery: A phase III randomized controlled trial,2024;17:e70081.

 

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