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　　 Changjiang Securities

Event description:

　　 Lingrui Pharmaceutical On November 27, it was announced that the company had received the approval document for the drug registration of transdermal fentanyl patch issued by the State Food and Drug Administration, with the approval number of 2012S00690; Application classification: imitation; Registration classification: 6 chemical drugs; Drug approval number: GYZZ H20123327; The drug approval number is valid until November 21, 2017.

Event comment:

The approval progress exceeded expectations and began to enter the field of high barrier anesthetics: the company completed the bioequivalence test in August 2011, fed back the approval opinions in August 2012, and obtained the production approval document in late November. The approval progress exceeded our expectations. It is expected that after the GMP certification is completed in the first half of 2013, the fentanyl patch can be officially put into production and marketed, marking the company's official entry into the high barrier field of anesthetics. China has strict control over the narcotics industry chain, among which there can only be 3 manufacturers of unilateral anesthetic preparations, and only Changzhou No.4 Pharmaceutical Co., Ltd. (the original research manufacturer of Janssen Pharmaceutical Agency) has obtained the approval in China. After being approved, the company will form a stable competition pattern, and there will be no new entrants to this variety in the next 3-5 years.

The patch is based on the field of analgesia and has a broad market space: traditional anesthetics are mainly used for clinical surgery analgesia, and fentanyl patch is mainly used for non-surgical analgesia. The base of narcotic drugs in China is low, and the growth is good. The main driving force for growth is the growing number of operations, and it benefits from the demand for cancer pain and non cancer pain relief, import substitution, etc. Because of its low addiction and relatively small respiratory inhibition, the analgesic effect of fentanyl series products is dozens of times that of other similar products, and it has quickly been recognized by doctors and patients, its popularity is getting higher and higher, and its safety has been fully verified. It is estimated that the theoretical market volume of fentanyl patch alone in the field of cancer pain exceeds 2 billion yuan.

Open up the growth space and make contributions to the performance in 2013: the company's main growth point is the oral medicine business at present, focusing on Peiyuan Tongnao Capsule, Danlu Tongdu Tablets and other varieties. The approval of fentanyl transdermal patch will greatly enrich the company's product line and open up the company's growth space. The company adopts more advanced skeleton type process, with relatively obvious technical advantages and more lasting efficacy. The production capacity of the first phase of fentanyl patch is 50 million patches/year, and the sales promotion has begun to plan. It is estimated that the initial stage will be dominated by agents, and it will contribute to the performance in 2013.

In 2014, it increased EPS by 0.1 yuan and maintained the "recommended" rating: the company's mechanism was gradually improved and its operation and management were on the right track; The obvious advantages of oral medicine varieties are the main driving force for the current performance growth; Fentanyl patch was approved and is expected to quickly become a growth point of performance. It began to contribute to performance in 2013 and increased by 0.1 yuan in 2014. It is estimated that the company's EPS in 2012-2013 will be 0.25 yuan and 0.45 yuan respectively. We believe that the company's operation will continue to improve, with great performance flexibility, and maintain the "recommended" rating.

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