Shandong Medicine Glass (600529): Draft National Drug Packaging Material Standard Draft Released for Consultation on Consistency Evaluation of Injections

Shandong Medicine Glass (600529): Draft National Drug Packaging Material Standard Draft Released for Consultation on 武汉夜生活网 Consistency Evaluation of Injections

Event: On October 15, the State Food and Drug Administration issued the “Technical Requirements for Consistent Evaluation of the Quality and Efficacy of Generic Drugs for Injection of Chemicals”.Ensure that the quality of the drug is consistent with the reference product “. Compared with the previous draft,” Packaging materials and containers used in direct contact with drugs should meet the standards for packaging materials specified by the General Administration of the State. The use of low-borosilicate and soda-lime glass is not recommended “.

The “Draft for Comment” was released to promote the upgrading of the medicinal glass industry: the reference formulation of generic drugs corresponds to foreign original research drugs, and the “Draft for Comment” further clarified that the quality 佛山桑拿网 of packaging materials and containers is not lower than the original research drugat this point.

As of October 16, a total of 138 pharmaceutical companies across the country had applied for 165 different injections of 78 injections of different specifications, and a total of 228 applications had registered for conformity evaluation. However, the final documents for the consistency evaluation of injections have not yet been issued, and the current status isIn the review and approval of the drug review center.

The later formal documents are expected to be issued. It is expected to accelerate the registration and replacement of injectable drugs, the long-term boost of the growth in demand for neutral borosilicate glass, and the upgrade of the overall demand structure of the domestic pharmaceutical glass industry.

The market has huge room for upgrading, and the industry concentration is expected to further increase: the proportion of European countries’ only essential medicines that explicitly use Class I glass packaging has reached 69.

3%, neutral borosilicate glass (Class I) will replace the low-borosilicate and soda-lime glass inserted in the internal medicinal glass market.

The price of neutral borosilicate glass is low borosilicate and soda lime glass 4?
5 times or more, it is expected that there is huge room for domestic demand to be upgraded.

In addition, the National Pharmacopoeia Bureau intensively released the draft national pharmaceutical packaging material standards. The industry standards have been significantly improved earlier, and the overall demand of overlapping industries has been upgraded.The industry concentration is expected to rise further.

The industry standard is becoming stricter, and the neutral borosilicate molding process has advantages: the neutral borosilicate glass molding bottle is formed in one shot, and the stability and tolerance are better than the control process.Advantage.

Molding process and regulating process products can be replaced in the field of 5-20ml specifications, although in the short term, the neutral borosilicate molding bottle of the same specification has a certain gap in weight and price from the neutral borosilicate regulating bottle of the same specification.However, it is translated into the release of the overall demand for neutral borosilicate, technological progress, scale effects and the improvement of production efficiency. It is expected that the competitive advantage of neutral borosilicate molded bottles will be improved in the future.

Long and short, century-old medicine glass: Shandong medicine glass is a domestic medical glass leader. It is committed to developing its existing products into world-class products, continuously maintaining a leading position in total cost, and continuously improving products (neutralBoron) silicon molding and regulation technology prepares synchronously and differentiates service layout, thereby steadily improving competitive advantages, and will continue to benefit from the upgrading of industry demand structure and industry concentration.

Maintain the company’s 19-21 profit forecast EPS 0.

78, 0.

98, 1.

22 yuan, maintain “Buy” rating.

Risk reminder: the policy falls short of expectations, the demand growth rate is lower than expected, the prices of raw materials and fuels rise, the uncertainty of trade frictions, and exchange loss gains and other risks.