Qilu Pharmaceutical's Tafamidis Meglumine Soft Capsules, First Domestic Generic for Rare Disease ATTR-PN, Approved for Market Launch

Tafamidis Meglumine Soft Capsules, for the treatment of adult transthyretin amyloidosisAmyloidosisPatients with Stage I symptoms of Transthyretin Amyloid Polyneuropathy (ATTR-PN) can effectively delay peripheral nerve function damage. Transthyretin Amyloid Polyneuropathy is a rare, hereditary, progressively worsening, and fatal disease that predominantly affects individuals aged 30-40 and is irreversible, posing a serious threat to patient survival. Clinically, it mainly manifests as symmetrical nerve dysfunction progressing from the distal to the proximal limbs, involving motor, sensory, and autonomic nerves, and may also include damage to other organs such as the heart, kidneys, and eyes.

The active ingredient in Chlorbenzazole Amine Soft Capsules, chlorbenzazole amine, is a transthyretin (TTR) stabilizer that works by selectively binding to TTR, stabilizing it and slowing down its dissociation into monomers, delaying the production and deposition of ATTR amyloidosis, thereby achieving therapeutic effects. According to large-scale long-term studies, for early-onset patients with the V30M mutation, chlorbenzazole amine soft capsules can reduce the risk of death by 91% compared to no treatment and by 63% compared to liver transplantation. For late-onset patients with the V30M mutation, chlorbenzazole amine soft capsules can reduce the risk of death by 82% compared to no treatment.

The original research product of Tafamidis Meglumine Soft Capsules was launched in China in 2020, with considerable treatment costs. To meet the unmet clinical medication needs,Qilu PharmaceuticalIn the same year, the development of Tafamidis Meglumine Soft Capsules was initiated. The R&D team, adhering to the concept of "quality by design," conducted scientific and meticulous research on the product to ensure comprehensiveness and integrity. Through multiple optimizations of the production process and experimental validations, they resolved the issue of decreased cross-linking dissolution, thereby ensuring that the in vitro dissolution profile and quality of the self-produced product were similar and equivalent to those of the originator product, with both sharing pharmaceutical andBioequivalenceAs of now, Qilu Pharmaceutical has cumulatively had 168 products pass or be considered to have passed the consistency evaluation, of which 57 are the first in China.

The launch of Qilu Pharmaceutical's Tafamidis Methylglucamine Soft Capsules will bring greater hope for the treatment of patients with transthyretin amyloidosis polyneuropathy and significantly reduce the financial burden of treatment. With improved drug accessibility, an increasing number of patients will receive more standardized treatment, thereby slowing disease progression, improving quality of life, and extending lifespan.

Qilu Pharmaceutical has always been patient-centered and clinically oriented, focusing on urgent clinical needs and unmet demands. It researches, develops, and produces high-quality, affordable medicines that the common people in China can access and afford. In the future, Qilu Pharmaceutical will continue to demonstrate its mission of "expressing our love through technology" with concrete actions, contributing Qilu's strength to safeguarding human health.