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Other Disclosures4577Daito Pharmaceutical Co.,Ltd.Pharmaceuticals

Daito Group Obtains Approval for Its Sixth In-House Generic Drug Product in China

Daito Pharmaceutical Co.,Ltd.'s consolidated subsidiary in China obtained approval from the Chinese authorities to manufacture and market Eperisone Hydrochloride Tablets 50 mg (盐酸乙哌立松片 50mg), a treatment for stiff shoulders, neck pain and other conditions. This is the sixth proprietary generic drug from the Daito Group to be approved in China.

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Announced details

Eperisone Hydrochloride Tablets 50 mg (盐酸乙哌立松片 50mg)
Applicable field (uses covered by this announcement)

Treatment of stiff shoulders, neck pain and other conditions

What the company reported numerically
Usage history

The Daito Group's sixth proprietary generic drug in China

Relationship between the counterparty and the company
Daito Pharmaceutical Co.,Ltd.4577
Relationship with the Company

大桐製薬(中国)有限責任公司, a consolidated subsidiary of Daito Pharmaceutical Co.,Ltd., obtained the approval. The active pharmaceutical ingredient is scheduled to be manufactured by the group company 安徽鼎旺医薬有限公司.

CounterpartyChina's National Medical Products Administration (NMPA)

China's pharmaceutical regulatory authority

Location (as indicated in this announcement)

大桐製薬(中国)有限責任公司: Hefei, Anhui, China / 安徽鼎旺医薬有限公司: Anqing, Anhui, China

Impact on Business Performance

The impact has already been incorporated into the earnings forecast, and there is no revision to the consolidated earnings forecast.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

China's National Medical Products Administration (NMPA)

Announced details
ItemDetails
Names of Products / Services CoveredEperisone Hydrochloride Tablets 50 mg (盐酸乙哌立松片 50mg)
CounterpartyChina's National Medical Products Administration (NMPA)
Counterparty overviewChina's pharmaceutical regulatory authority
Relationship with the Company大桐製薬(中国)有限責任公司, a consolidated subsidiary of Daito Pharmaceutical Co.,Ltd., obtained the approval. The active pharmaceutical ingredient is scheduled to be manufactured by the group company 安徽鼎旺医薬有限公司.
Applicable areaTreatment of stiff shoulders, neck pain and other conditions
Location大桐製薬(中国)有限責任公司: Hefei, Anhui, China / 安徽鼎旺医薬有限公司: Anqing, Anhui, China
Usage historyThe Daito Group's sixth proprietary generic drug in China
Impact on Business PerformanceThe impact has already been incorporated into the earnings forecast, and there is no revision to the consolidated earnings forecast.
SourceChina's National Medical Products Administration (NMPA)
Items this document does not state (9)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleQuantitative Effects

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

In response to regulatory changes in China, the parties agreed that having 大桐製薬 hold the manufacturing and marketing rights would provide a competitive advantage in its sales strategy.

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Daito Group Obtains Approval for Its Sixth In-House Generic Drug Product in China | Daito Pharmaceutical Co.,Ltd. (4577) timely disclosure | Komori