On July 19, the CDE official website showed,Hainan Herui Pharmaceutical Co., Ltd.Category 4 chemical generic drugs submitted for approvalMilnacipran Besylate TabletsThe listing application has been accepted.Huirui PharmaceuticalThus officially joining the race to be the first to replicate this variety.

Screenshot source: CDE official website

Mirogabalin（mirogabalin）It is a third-generation calcium channel modulator, indicated for diabetic peripheral neuropathic pain.（DPNP）, mainly by regulating calcium ion channels, reducing the inflow of calcium ions, thereby inhibiting neuronal overexcitation and excessive release of neurotransmitters.

Source of screenshot: Mesentech Global Drug R&D Database

Milnacipran Besylate TabletsByDaiichi Sankyo Company, Limited（Daiichi Sankyo）Independently developed and originally marketed, it was first approved in Japan in 2019.

According to the Moentropy Medicine database, since its launch,Milnacipran Besylate TabletsGlobal sales continued to soar, with cumulative sales reaching 142.9 billion yen from 2019 to 2023.(Approximately 1 billion US dollars at the current exchange rate), with global sales reaching nearly 400 million USD in 2024, representing a year-on-year increase of 21.59%.

Source of screenshot: Mesentech Global Drug R&D Database

June 2024,Milnacipran Besylate TabletsApproved for entry into the Chinese market, breaking the long-standing treatment dilemma in China where no drugs were available for diabetic peripheral neuropathic pain. In the same November, it was included in the medical insurance catalog through negotiation.

According to data from Mose Pharm, the number of diabetes patients in China reached 117 million in 2021, with an increasing trend year by year. As the most common chronic complication of diabetes, diabetic peripheral neuropathy（DPN）The incidence rate in China is about 21.8%, of which 57.2% will develop into diabetic peripheral neuropathic pain.（DPNP）。

Screenshot source: Mosentropy Medical Epidemiology Database

Relying on China's large base of diabetes patients and unmet treatment needs,Milnacipran Besylate TabletsExpected to replicate similar neuropathic pain drugsGabapentin's market performance, growing into a blockbuster variety with a scale of hundreds of millions.

Screenshot source: Mosentropy Medicine National Hospital Sales (All-Terminal) Database

As a breakthrough product to address the lack of drugs in the therapeutic field,Mirogabalin Besylate TabletsEntering the Chinese market for only one year has attracted keen attention from domestic companies, and a wave of generic drugs in the painkiller niche track has already emerged.

ExceptHuirui PharmaceuticalExternally,Chia-TaiTianqing、Qilu Pharmaceutical、Chengdu Easton Bio Pharmaceuticals Co.,LtdApplications from 3 enterprisesMilnacipran Besylate TabletsThe listing application has been accepted and is currently in the review stage, marking the beginning of the race for the first generic drug.

Screenshot source: Moentropy Medicine China Drug Evaluation Database

It is worth noting that,Chia-TaiTianqingAs the first pharmaceutical company in China to file for the generic drug's market approval and initiate bioequivalence (BE) trials, the company entered the market application process immediately after completing the trials from September to November 2023, showcasing remarkable efficiency. Currently, seven pharmaceutical companies have completed BE trials, while another 13 are still in progress.

Screenshot source: Mosan Medical China Clinical Trial Database

Mirogabalin BesylateThe core compound patent has been granted in China.（CN101878193B）, protection period until September 2028.Daiichi SankyoPatent layouts have also been made in formulation compositions and solid formulations, involving patents such as CN104334169B, CN114786653B, and CN107405322B.

Source of screenshot: Mosentropy Global Marketing Drug Patent Database

As the third-generation calcium channel modulator,Mirogabalin Besylate TabletsThe advantages of rapid onset, long-lasting pain relief, and good tolerability can bring multiple benefits to DPNP patients. Now that the competition for the first generic has officially begun, we wait with bated breath to see which company will be the first to break through and compete with the original research company, Daiichi Sankyo.

END

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