Hongqi Pharmaceutical
HONGQI PHARMACEUTICAL
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Inclusive access upgraded! Shenyang Hongqi Pharmaceutical’s bedaquiline has been approved—making it the first domestic company to offer a complete portfolio of BPaL/M regimens.
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Add time:2026-05-13 14:57
Multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) represents a core challenge in China’s tuberculosis control efforts. Conventional treatment regimens span 18 to 24 months, with low cure rates, high costs, and significant adverse effects. WHO tuberculosis guidelines. [1] The recommended BPaL/M short-course regimen—bedaquiline, pretomanid, and linezolid, with or without moxifloxacin—has become the global first‑line treatment for drug‑resistant tuberculosis, offering a 6‑month course with a cure rate exceeding 90%. The approval of bedaquiline by Shenyang Hongqi Pharmaceutical has fully established a domestic production chain for this regimen, thereby filling the gap in the availability of the complete treatment course.
Shenyang Hongqi Pharmaceutical has been deeply engaged in the anti-tuberculosis field for over 60 years, having served more than 15 million patients to date. In a single-dose oral study conducted in healthy Chinese subjects, participants received either bedaquiline fumarate tablets (100 mg) manufactured by Shenyang Hongqi Pharmaceutical Co., Ltd. or bedaquiline fumarate tablets licensed by Janssen‑Cilag International N.V. (trade name: Sirturo®, 100 mg). Bioequivalence (BE) data are fully equivalent. [2] , the core pharmacokinetic parameters meet the equivalence criteria, absorption and metabolism are highly consistent with the reference product, and efficacy and safety are assured, It is a reliable alternative to the original product. 。
The original research‑developed bedaquiline is prohibitively expensive, and even after being included in national health insurance, it still places a financial burden on some patients. Shenyang Hongqi Pharmaceutical remains committed to a patient‑centered approach; the bedaquiline tablets recently approved… Shenyang Hongqi Pharmaceutical has essentially completed its inventory preparations and is now able to ensure the timely supply of its medications. , rapidly benefiting drug-resistant patients in China. Meanwhile The pricing will be lower than the originator product. , making the BPaL/M regimen more inclusive. As Domestic enterprises that possess the core drug of this formulation. Its “one-stop” supply model helps prevent patients from having their treatment interrupted due to drug shortages, truly ensuring that medications are both accessible and affordable.
Within six months, Shenyang Hongqi Pharmaceutical has completed the domestic production rollout of the core drugs in the BPaL/M regimen, aligning with the national prevention and control strategy. Moving forward, the company will continue to optimize its supply chain and strengthen clinical promotion, ensuring that high‑quality, affordable short‑course regimens benefit more patients and underscoring the responsibility and commitment of a leading Chinese pharmaceutical enterprise.
[1] WHO consolidated guidelines on tuberculosis. Module 4: treatment and care. Geneva: World Health Organization; 2025. Licence: CC BY-NC-SA 3.0 IGO.
[2] Bioequivalence data are derived from the sponsor’s bioequivalence study report and constitute a prerequisite for new drug approval.
