Hongqi Pharmaceutical
HONGQI PHARMACEUTICAL
Cherish life, pay attention to health.
CHERISH LIFE CARE ABOUT HEALTH
The star drug for multidrug-resistant tuberculosis, Preny (Pretomanid Tablets), has been successfully launched.
Category:
Trade info
Author:
Source:
Add time:2025-01-02 11:02
On December 3, 2024, the NMPA's latest drug approval certificate delivery information indicated Shenyang Hongqi Pharmaceutical Co., Ltd.'s Puruini® Pretomanid tablets have been officially approved, NMPA approval number HJ20240153. Public information shows that Pretomanid is a new molecular entity developed by the TB Alliance; the drug was approved by the US FDA in 2019 and, when used in combination with bedaquiline and linezolid, is used to treat certain patients with highly drug-resistant pulmonary tuberculosis. The drug was also selected for the 2020 Galen Award 'Best Drug Award' 。
Pretomanid has been approved in Hong Kong and is already marketed in Taiwan. In addition, Pretomanid has received WHO recognition and has been rolled out in over 60 countries and regions worldwide.
China still faces many challenges in treating drug-resistant tuberculosis.
China is one of the high-burden tuberculosis countries in the world; according to the latest World Health Organization (WHO) data 1 , there were 400,000 people with drug-resistant TB worldwide in 2023. China is estimated to have 29,000 drug-resistant TB patients (7.3% of the global total), ranking fourth in the world, and the treatment success rate for China's MDR/RR-TB patients is only 66%. The commonly used long-course clinical regimen currently lasts 18–20 months, involves 5–7 different drugs, and can require up to 30 pills per day. Chinese patients with drug-resistant TB urgently need new short-course, potent, and safe treatment regimens. 。
With Pretomanid's approval, China's drug-resistant tuberculosis
is about to enter the era of 6-month short-course treatment.
Pretomanid is a novel nitroimidazole compound for antimycobacterial use, with a unique multi-mechanism of action and both bactericidal and sterilizing activity. 2-4 。
Under aerobic conditions, it inhibits the biosynthesis of mycobacterial fatty acids, disrupting cell wall synthesis and thereby killing replicating Mycobacterium tuberculosis;
Under anaerobic conditions, it releases nitric oxide, producing respiratory toxicity against non-replicating bacteria and thus exerting a bactericidal effect;
A specific mechanism: it targets the pentose phosphate pathway, causing accumulation of pentose phosphates, leading to toxic accumulation of methylglyoxal and arresting cell growth.
Puruini® On the market, China is about to open
a new chapter in the treatment of drug-resistant tuberculosis.
In December 2019, WHO issued a Rapid Communication on changes in the treatment of drug-resistant TB that for the first time recommended the BPaL regimen for pre-XDR-TB and MDR-TB patients with poor treatment outcomes. In WHO's 2022 DR-TB guidelines, the BPaLM regimen is recommended for RR/MDR-TB without fluoroquinolone resistance, and the BPaL regimen is recommended for pre-XDR-TB patients; these regimens are characterized by being short-course, highly effective, and safe. 5。
The guideline recommendations are based on three major clinical trials: Nix-TB 6 , Ze-Nix 7 , TB-PTACTECAL 8 The trial data show: 6 months of BPaL/M treatment, with treatment efficacy exceeding 90%. The median time to culture conversion is only 6 weeks and the relapse rate is nearly 0%; in recent years, the TB Alliance has carried out the 'LIFT-TB' study in seven countries in Southeast and Central Asia 9 , where these new regimens were used to treat DR-TB in multiple countries and achieved a cumulative success rate of 92.5%. This study has guiding significance for DR-TB treatment in the Asia-Pacific region.
Nix-TB is an open-label, single-arm study that enrolled 109 patients from three centers in South Africa (XDR-TB: n=71; MDR-TB: n=38) who received the BPaL regimen for 26 weeks and were followed for 24 months to evaluate the efficacy and safety of BPaL in XDR-TB and MDR-TB patients;
ZeNix is a multicenter, partially blinded, randomized, parallel-group controlled clinical study that enrolled 181 patients, 88% of whom had XDR-TB or pre-XDR-TB. On the basis of 26 weeks of bedaquiline + pretomanid treatment, patients were randomized to receive linezolid 1200 mg/day × 26 weeks, 1200 mg/day × 9 weeks, 600 mg/day × 26 weeks, or 600 mg/day × 9 weeks to explore the optimal dose and duration of linezolid in the BPaL regimen;
TB-PRACTECAL is an open-label, phase 2–3, multicenter, randomized, controlled, non-inferiority study that enrolled 552 RR-TB patients. In the first stage, participants were randomized 1:1:1:1 to receive standard treatment, BPaL, BPaLC, or BPaLM; in the second stage, participants were randomized 1:1 to standard treatment or BPaLM. Follow-up was 72 weeks to assess the efficacy and safety of a 24-week oral BPaLM regimen;
LIFT-TB is a prospective cohort study conducted by the TB Alliance in seven countries in Southeast and Central Asia that enrolled XDR-TB patients and MDR-TB patients with treatment failure or intolerance, aiming to evaluate the efficacy and safety of the BPaL regimen.
Shenyang Hongqi Pharmaceutical is a member company of Fosun Pharma. Since its establishment in 1964 (60 years to date), the company has always adhered to a patient-centered approach, continuously supplying high-quality tuberculosis medicines. As the Coordinated Reserve of Anti-TB Drug Supply of the Chinese Anti-TB Association, it has provided medicines to more than 15 million Chinese tuberculosis patients. The company has provided high-quality drugs. It values R&D and innovation and has actively advanced the introduction and market approval of Puruini to achieve access to the BPaL regimen in China.
In the future, BPaL regimens containing Puruini® will be promoted and applied in China, which will strongly support Chinese public health authorities in formulating and implementing more effective TB prevention and control plans and will provide strong assurance for achieving the goal of ending the TB epidemic.
1. 2024 Global Tuberculosis Report.
2. Stancil SL, et al. Drug Des Devel Ther, 2021 Jun 28;15:2815-830.
3. Linköping University Electronic Press, 2016.
4. Abrahams KA, et al. Nat Commun.2023 Jun 28;14(1):3828.
5. https://www.who.int/publications/i/item/9789240063129.
6. Conradie F, et al. N Engl J Med. 2020;382(10):893-902.
7. N Engl J Med. 2022 Sep 1;387(9):810-823.
8. Nyang'wa BT, et al. N Engl J Med.2022 Dec 22;387(25):2331-2343.
9. https://www.lifttb.org/progress-1.
