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Hebei Daily | 100 Generic Drugs Have Passed Evaluation—Innovation Is the Key

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发布时间：2024-09-09

【概要描述】 On August 13, two pharmaceutical products of Shijiazhuang Sihua Pharmaceutical Group received drug manufacturing registration approvals from the National Medical Products Administration and were deemed to have passed the bioequivalence and therapeutic equivalence evaluation for generic drugs. To date, Sihua Pharmaceutical has had 100 product varieties comprising 133 specifications of generic drugs either approved or deemed to have passed the equivalence evaluation, placing it among the leading domestic pharmaceutical companies in terms of the number of such approvals.

Hebei Daily | 100 Generic Drugs Have Passed Evaluation—Innovation Is the Key

On August 13, two pharmaceutical products of Shijiazhuang Sihua Pharmaceutical Group received drug production registration approvals from the National Medical Products Administration, which are deemed to have passed the bioequivalence and therapeutic equivalence evaluation for generic drugs. To date, Sihua Pharmaceutical has had 100 product varieties comprising 133 specifications of generic drugs either approved or deemed to have passed the equivalence evaluation, placing it among the top domestic pharmaceutical companies in terms of the number of such approvals.

Generic drugs are medications that are identical or highly similar to their originator counterparts in terms of active ingredients, dosage, potency, mechanism of action, and indications. At first glance, the term “generic drug” can mislead the public into believing that such products are of inferior quality. Some people also assume, based on experience, that domestically produced medicines lag behind imported drugs in both efficacy and quality. But what is the reality?

On August 14, a reporter visited Shisi Pharmaceutical to get to the bottom of the matter.

Workshop 209 is a newly constructed facility at Shisi Pharmaceutical specifically designed for the production of generic granules and dry-mix suspensions that have passed evaluation. The entire workshop is equipped with automated and intelligent manufacturing equipment, enabling fully automated, closed-loop handling and transportation of raw materials. This not only significantly enhances production efficiency but also reduces product exposure and material loss during the manufacturing process, thereby further ensuring overall product quality.

At the production floor, a newly approved product—cefuroxime axetil dry suspension—is currently being packaged and rolled off the line. Cefuroxime axetil is a novel anti-infective agent; however, most domestic pharmaceutical companies offer it primarily in tablet and granule formulations, which have a bitter taste and are inconvenient for children to take. Yang Yuxia, Deputy General Manager of Shisi Pharmaceutical’s Second Manufacturing Center, stated that, in response to the need for pediatric-friendly formulations, Shisi Pharmaceutical has specifically developed the dry suspension dosage form. By optimizing manufacturing processes and introducing innovative flavor-masking technologies, the company has effectively addressed the challenges associated with administering medication to children.

“We employ inclusion technology and a hot-melt freeze-granulation machine to encapsulate bitter-tasting active ingredients within palatable excipients through thermal melting, thereby improving the taste of the formulation,” explained Yang Yuxia.

On the 12-line blister-packaging production line in Workshop 209, boxes of cefaclor dry suspension are moving steadily along the conveyor. The line is equipped with electronic balances and, controlled by computer commands, can precisely regulate the dosage in each individual sachet. “This drug has been included in the centralized procurement program, so we must ensure sufficient output,” explained Yang Yuxia. She added that the production line boasts a capacity of 540 sachets per minute, making it one of the most highly automated and highest-capacity lines in China.

Generic drugs are primarily manufactured to replicate off-patent originator medications from abroad. Advanced production equipment can ensure pharmaceutical quality throughout the manufacturing process. However, quality management during the drug development phase plays an even more critical role in determining the overall quality of the product.

At the Liquid Chromatography Laboratory of the Shisi Pharmaceutical Research Institute, R&D personnel are operating instruments and recording test data. “The development of first-generic drugs and difficult-to-generate generics also requires substantial technological innovation,” said Xia Guolong, Deputy General Manager of the Shisi Pharmaceutical R&D Center. He explained that, in order to produce generic versions of originator drugs, companies must not only have a clear understanding of the drug’s chemical structure but also re-engineer formulation development, conduct bioequivalence studies, and carry out pilot production—all from scratch—essentially recreating the entire R&D and manufacturing process as if they were developing a new drug.

In recent years, Shisi Pharmaceutical has adopted a research-and-development strategy that combines generic drug development with innovative R&D. Leveraging a well-established innovation platform and a mature research management system, the company has pooled human and financial resources to systematically conduct consistency evaluations of generic drugs. “We have more than 600 R&D personnel, nearly 500 of whom are primarily engaged in the development of generic drugs,” said Xia Guolong. He added that developing a single generic drug can require an investment ranging from several million to over ten million yuan.

Breaking through critical technological bottlenecks and overcoming patent barriers associated with the synthesis methods of originator drugs, the company has pursued technological innovation in areas such as synthetic process routes and drug preparation methodologies. Shisi Pharmaceutical has prioritized the R&D of pediatric- and geriatric-friendly generic drugs; among the 100 generics that have passed evaluation, 22 were the first in China to do so. Notably, its dry-mix suspension of stiripentol—a rare pediatric drug (orphan drug) indicated for the treatment of severe myoclonic epilepsy in infants—has been exclusively approved.

In accordance with relevant national requirements, generic drugs that have passed the evaluation must be consistent with the originator drug in terms of quality and therapeutic efficacy and be clinically interchangeable with the originator drug.

“Once the patent on an originator drug expires, it is difficult for the company to lower prices on its own without the competitive pressure exerted by generic drugs,” said Xia Guolong. He added that Shisi Pharmaceutical will continue to leverage its innovation mechanism and platform that integrates industry, academia, research, and application to broaden its product pipeline and develop and manufacture more safe, affordable “Made-in-China” medicines.

(Reprinted from Hebei Daily)

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