Shanghai, July 4, 2024 — Luye Pharma Group announced that its Mimeixin (oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets) was approved for marketing by China's National Medical Products Administration (NMPA) on June 28, 2024, for the management of severe pain in adults that can only be effectively controlled using opioids, including cancer pain and non-cancer pain. Mimeixin contains naloxone, an opioid receptor antagonist, which reduces opioid-induced constipation (OIC) by blocking the binding of oxycodone to opioid receptors in the gut.
In China, the development and production of anaesthetic and psychotropic drugs are under strict control: companies developing and manufacturing such products have to obtain a special license, and the total number of companies allowed to develop or manufacture these products is set by the government, meaning that the bar is high for companies to enter this industry. Mimeixin is currently the only locally made product of oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets approved in China. Combining the potent opioid receptor agonist oxycodone and the opioid receptor antagonist naloxone, it can effectively manage pain while mitigating OIC. A single dose of Mimeixin provides up to 12 hours of pain relief. The product also adopts a proprietary medication-locking technology to prevent drug abuse.
A combination therapy addresses the challenge in managing cancer pain
All types of cancer frequently cause pain, a torturous symptom that significantly compromises patients’ quality of life1. Data from the World Health Organization's International Agency for Research on Cancer (IARC) shows that China had nearly 4.82 million new cases of cancer in 2022 alone2. Pain affects 60% to 80% of patients with advanced cancer, and one third of the affected individuals experience severe pain1. In recent years, oxycodone in sustained-release tablets has become one of the most commonly used potent opioid analgesics for treating moderate to severe chronic cancer pain, playing a crucial role in clinical practice3.
“OIC often accompanies the entire pain management process, which is a severe and intolerable complication, and some patients may reduce or discontinue their pain relievers because of that,” said Professor Pan Hongming from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, who chairs the Supportive and Palliative Care Committee of the Chinese Society of Clinical Oncology. “Existing treatments, including the use of laxatives, are limited in relieving OIC, so more effective treatments are urgently needed.” He said that Mimeixin is upgraded from the sustained-release formulations of oxycodone, working with naloxone to relieve pain while preventing OIC or improving its symptoms and significantly reducing the use of laxatives. This combination simplifies pain management for patients and improves their quality of life, according to him.
A number of clinical studies have demonstrated that, compared with the sustained-release monotherapies of oxycodone, the sustained-release combination therapies of oxycodone and naloxone are equivalent in analgesic effects at the same dosage, but can significantly improve bowel function and reduce the incidence and severity of OIC3,4. Furthermore, both the NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain (Version 2, 2024) and the Management of Cancer Pain in Adult Patients: ESMO Clinical Practice Guidelines state that the prolonged-release combination formulations of oxycodone and naloxone can significantly improve OIC in cancer pain patients undergoing long-term opioid therapy5,6.
In addition to the management of cancer pain, the oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets can also effectively relieve the pain for patients with moderate to severe musculoskeletal pain, postoperative pain or lower back pain, and significantly improve their constipation, as demonstrated in multiple clinical trials3.
The proprietary medication-locking technology reduces the risk of oxycodone abuse
The high risk of psychological dependence associated with opioid analgesics contributes significantly to opioid abuse, a major public health challenge in the world. Mimeixin adopts a proprietary medication-locking technology to prevent people from grinding, extracting and converting oxycodone, thus reducing drug abuse. Additionally, naloxone, by antagonizing the activity of oxycodone, can prevent the abusers from experiencing euphoria and induce precipitated withdrawal, a mechanism of action that helps to further reduce the risk of abuse.
Yang Rongbing, President of Luye Pharma Group, said: “Severe chronic pain caused by major illnesses like cancer significantly compromises patients' quality of life, which is yet to be adequately addressed. Mimeixin is our first analgesic approved for marketing in China. Our oncology team will make it available to patients with cancer pain as soon as possible. And the next step will be to expand its application to cover other diseases as well. We will also develop more analgesic products in the future as part of our efforts to provide innovative therapies for patients and improve human health with our expertise.”
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
References：
1. The Cancer Pain Management Guidelines issued by the National Health Commission of the People's Republic of China [EB/OL]. (2018-10-02) [2024-07-04]. https://www.gov.cn/xinwen/2018-10/02/content_5327533.htm
2. BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA Cancer J Clin. 2024;74(3):229-263.
3. Zhang L, Sun Q, Xue Y. Advances in Research on the Use of Oxycodone-Naloxone Sustained-Release Tablets for the Treatment of Moderate to Severe Pain [J]. China Medicine and Pharmacy, 2023,13(22):30-34.
4. The maximum daily dose of Mimeixin is 160mg of oxycodone hydrochloride /80mg of naloxone hydrochloride.
5. NATIONAL COMPREHENSIVE CANCER NETWORK. NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain Version 2.2024 [EB/OL]. (2024-03-11) [2024-07-04]. https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf
6. FALLON M, GIUSTI R, AIELLI F, et al. Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines [J]. Ann Oncol, 2018, 29 (Suppl 4): iv166-iv191.
Shanghai, July 4, 2024 — Luye Pharma Group announced that its Mimeixin (oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets) was approved for marketing by China's National Medical Products Administration (NMPA) on June 28, 2024, for the management of severe pain in adults that can only be effectively controlled using opioids, including cancer pain and non-cancer pain. Mimeixin contains naloxone, an opioid receptor antagonist, which reduces opioid-induced constipation (OIC) by blocking the binding of oxycodone to opioid receptors in the gut.
In China, the development and production of anaesthetic and psychotropic drugs are under strict control: companies developing and manufacturing such products have to obtain a special license, and the total number of companies allowed to develop or manufacture these products is set by the government, meaning that the bar is high for companies to enter this industry. Mimeixin is currently the only locally made product of oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets approved in China. Combining the potent opioid receptor agonist oxycodone and the opioid receptor antagonist naloxone, it can effectively manage pain while mitigating OIC. A single dose of Mimeixin provides up to 12 hours of pain relief. The product also adopts a proprietary medication-locking technology to prevent drug abuse.
A combination therapy addresses the challenge in managing cancer pain
All types of cancer frequently cause pain, a torturous symptom that significantly compromises patients’ quality of life1. Data from the World Health Organization's International Agency for Research on Cancer (IARC) shows that China had nearly 4.82 million new cases of cancer in 2022 alone2. Pain affects 60% to 80% of patients with advanced cancer, and one third of the affected individuals experience severe pain1. In recent years, oxycodone in sustained-release tablets has become one of the most commonly used potent opioid analgesics for treating moderate to severe chronic cancer pain, playing a crucial role in clinical practice3.
“OIC often accompanies the entire pain management process, which is a severe and intolerable complication, and some patients may reduce or discontinue their pain relievers because of that,” said Professor Pan Hongming from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, who chairs the Supportive and Palliative Care Committee of the Chinese Society of Clinical Oncology. “Existing treatments, including the use of laxatives, are limited in relieving OIC, so more effective treatments are urgently needed.” He said that Mimeixin is upgraded from the sustained-release formulations of oxycodone, working with naloxone to relieve pain while preventing OIC or improving its symptoms and significantly reducing the use of laxatives. This combination simplifies pain management for patients and improves their quality of life, according to him.
A number of clinical studies have demonstrated that, compared with the sustained-release monotherapies of oxycodone, the sustained-release combination therapies of oxycodone and naloxone are equivalent in analgesic effects at the same dosage, but can significantly improve bowel function and reduce the incidence and severity of OIC3,4. Furthermore, both the NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain (Version 2, 2024) and the Management of Cancer Pain in Adult Patients: ESMO Clinical Practice Guidelines state that the prolonged-release combination formulations of oxycodone and naloxone can significantly improve OIC in cancer pain patients undergoing long-term opioid therapy5,6.
In addition to the management of cancer pain, the oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets can also effectively relieve the pain for patients with moderate to severe musculoskeletal pain, postoperative pain or lower back pain, and significantly improve their constipation, as demonstrated in multiple clinical trials3.
The proprietary medication-locking technology reduces the risk of oxycodone abuse
The high risk of psychological dependence associated with opioid analgesics contributes significantly to opioid abuse, a major public health challenge in the world. Mimeixin adopts a proprietary medication-locking technology to prevent people from grinding, extracting and converting oxycodone, thus reducing drug abuse. Additionally, naloxone, by antagonizing the activity of oxycodone, can prevent the abusers from experiencing euphoria and induce precipitated withdrawal, a mechanism of action that helps to further reduce the risk of abuse.
Yang Rongbing, President of Luye Pharma Group, said: “Severe chronic pain caused by major illnesses like cancer significantly compromises patients' quality of life, which is yet to be adequately addressed. Mimeixin is our first analgesic approved for marketing in China. Our oncology team will make it available to patients with cancer pain as soon as possible. And the next step will be to expand its application to cover other diseases as well. We will also develop more analgesic products in the future as part of our efforts to provide innovative therapies for patients and improve human health with our expertise.”
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
References：
1. The Cancer Pain Management Guidelines issued by the National Health Commission of the People's Republic of China [EB/OL]. (2018-10-02) [2024-07-04]. https://www.gov.cn/xinwen/2018-10/02/content_5327533.htm
2. BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA Cancer J Clin. 2024;74(3):229-263.
3. Zhang L, Sun Q, Xue Y. Advances in Research on the Use of Oxycodone-Naloxone Sustained-Release Tablets for the Treatment of Moderate to Severe Pain [J]. China Medicine and Pharmacy, 2023,13(22):30-34.
4. The maximum daily dose of Mimeixin is 160mg of oxycodone hydrochloride /80mg of naloxone hydrochloride.
5. NATIONAL COMPREHENSIVE CANCER NETWORK. NCCN Clinical Practice Guidelines in Oncology: Adult Cancer Pain Version 2.2024 [EB/OL]. (2024-03-11) [2024-07-04]. https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf
6. FALLON M, GIUSTI R, AIELLI F, et al. Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines [J]. Ann Oncol, 2018, 29 (Suppl 4): iv166-iv191.
