Shanghai Pharmaceuticals Announces Generic Cimetidine Tablets and Perindopril Tert-butylamine Tablets Pass Consistency Evaluation

On May 12, SPH announced that its wholly-owned subsidiary had received the "Notice of Approval for Supplementary Drug Application" issued by the National Medical Products Administration (NMPA) for Cimetidine Tablets and Perindopril Tert-butylamine Tablets (4 mg, 2 mg). The aforementioned drugs have passed the consistency evaluation of quality and efficacy for generic drugs.

Cimetidine Tablets are mainly indicated for the relief of gastric pain, heartburn (pyrosis), and acid regurgitation caused by excessive gastric acid.Developed by GlaxoSmithKline PLC., it was first launched in the United States in 1977. In May 2019, Shanghai Pharmaceuticals Tianping regarding cimetidineAn application for the consistency evaluation of the generic drug Cimetidine Tablets has been submitted to the National Medical Products Administration (NMPA) and accepted. As of the date of this announcement, the Company’s cimetidine-Approximately RMB 7.86 million has been invested in the research and development of the consistency evaluation for Tiding Tablets.As of the date of this announcement, the main manufacturers of this drug in China are Tianfang Pharmaceutical Co., Ltd. and Sino-US Tianjin SmithKe Pharmaceutical Co., Ltd., etc. The IQVIA database shows that the hospital procurement amount for the oral solid dosage form of this drug in 2020 wasRMB 76.62 million. In 2020, the sales revenue of Xinyi Tianping's Cimetidine Tablets was RMB 77.13 million.

Perindopril Tert-butylamine Tablets are primarily indicated for hypertension and congestive heart failure, developed by Servier, mostFirst marketed in Europe in 1988. In December 2019 and January 2020, SPH Dongying filed for perindopril tert-butylamine tabletsThe application for the generic drug consistency evaluation has been submitted to the National Medical Products Administration (NMPA) and accepted. As of the date of this announcement, the company’s perindoprilApproximately RMB 6.98 million has been invested in the research and development of the consistency evaluation for tert-butylamine tablets.As of the date of this announcement, the main manufacturers of this drug in China are Servier (Tianjin) Pharmaceutical Co., Ltd.,Ningbo Menovo Tiankang Pharmaceutical Co., Ltd., Haisco Pharmaceutical (Meishan) Co., Ltd., etc. The IQVIA database shows that,In 2020, the hospital procurement amount for this product was RMB 572.1 million. In 2020, SPH Dongying's perindopril tert-butylamineSales revenue from amine tablets amounted to RMB 33.89 million.