Nanjing Chia Tai Tianqing Submits Clinical Application for Ramelteon Tablets to Challenge Takeda's Blockbuster Insomnia Drug

Recently, Chia-TaiTianqing submitted the first clinical drug application of the year for Ramelteon Tablets, an oral hypnotic developed by Takeda. The original drug has not yet been imported into China, with global sales reaching 19.1 billion yen (approximately 160 million USD at the exchange rate at that time) in 2018.

Figure 1: Latest Product Applications by Chia-Tai Tianqing in Nanjing

Source: CDE official website

Data show that ramelteon is the first melatonin receptor agonist applied clinically for the treatment of insomnia, and also the first and so far the only prescription insomnia treatment drug without abuse and dependence potential. It is mainly used to treat sleep onset insomnia and has proven efficacy for chronic and short-term insomnia as well.

Data from MiNe Network shows that Takeda Pharmaceutical Company Limited submitted an import clinical application for Ramelteon Tablets in 2007 and obtained the clinical approval, but has not yet applied for import market approval. More than 10 pharmaceutical companies in China have obtained clinical approvals for Ramelteon Tablets. In 2021, TransOcean Pharmaceuticals Development (Guangzhou) submitted a clinical application for a new drug of category 2.2, Ramelteon Dual-Release Tablets, and received clinical approval.

Figure 2: Clinical Status of Ramelteon in China

Source: New Version Database of Meneven

Wuhan Changlian Laifu Pharmaceutical/Wuhan Xianlu Pharmaceutical Technology conducted a bioequivalence trial of ramelteon tablets in 2019, indicated for improving sleep in patients with insomnia, making it the domestic pharmaceutical company with the fastest clinical progress currently.

Table 1: Product Applications by Chia-TaiTianqing in Nanjing in 2021

Source: MiNeiNet MED2.0 China Drug Evaluation Database

Chia-TaiTianqing's R&D strength is also not to be underestimated. In 2021, the company's Class 1 new drug NTQ1062 tablet, for which clinical trials were applied, has obtained clinical approval and is currently undergoing Phase I clinical trials for advanced solid tumor indications. Additionally, five chemical drugs applied for generic production are expected to achieve first-to-market generics.

Note: The original text has been abridged.

Source: CDE official website, Mening Network database

Data statistics as of March 23rd. If there are any omissions, corrections are welcome!