Interview Shijiazhuang Shimu Animal Pharmaceutical Co., Ltd.

What are the main product series of the company?

Veterinary preparations and APIs; veterinary preparations include powder, premix, tablets, granules, injections, breast perfusion fluid, disinfectant, and insecticide, etc., with the antimicrobials, antiviral drugs, antiparasitic drugs, and nutriceuticals, etc. that can be used for poultry, pigs, horses, cattle, sheep, camels, fur animals, and aquatic products, etc.

What are the main application fields of products of the company? How are their performance on the market?

The application fields include pasture breeding, poultry raising, and aquiculture, etc. Products of Shimu have good competitive edges thanks to the product differentiation, wherein, its TCMs have broad market prospects, especially, the market prospects of its TCM antiviral drugs are promising.

What new products will the company launch in the future?

Micro-ecological preparations, enzyme preparations, TCM preparations, and biologics

What are the most popular products in the product catalog of the company? How are their performance on Chinese and overseas markets?

Antiparasitic Albendazole Tablets, Ivermectin Injection, antibiotic Oxytetracycline Injection, Tylosin Injection, and traditional Chinese veterinary medicines, etc. are most popular, and their sales continue to rise owing to strict product quality monitoring and stable customers.

What are the most popular product specifications of the company? How is the relevant capacity?

Oxytetracycline Injection 20%, 10%, 5%, 50ml, 100ml. The capacity is 63 million bottles/a.

What is the synthetic route of the products? Do they have patent protection?

Weighing-concentrated solution preparation-diluted solution preparation-filtration-filling-capping-sterilization-visual inspection-packaging. The product is a pharmacopeia drug, therefore, it is not protected by patent.

With the escalation of environmental issues, do they have large impacts on the production of the company? Do the product prices have large fluctuations?

The main impacts are on the cost control of raw materials. The production of veterinary preparations depends on procurement of raw and auxiliary materials and packaging materials in pharmaceutical industry, while the raw material pharmaceutical factories and packaging manufacturers are the first to be affected by environmental issues, which directly affect the production cost. Due to increase of pressure for environmental protection, the purchasing department of the company will stock up raw materials of products in strong demand, to guarantee the smooth production and cost control of the company.

What is roughly the global market size of the products? What are the differentiation advantages of the products?

As oxytetracycline aqueous solution is decomposed through epimerization reaction, dehydration reaction, hydrolysis reaction, and oxidation reaction, the injection preparation thereof easily changes color or precipitates, and even turns black when exposed to heat or stored for a long time under acidic or alkaline condition, resulting in the active ingredients to reduce, thereby reducing the efficacy, which is a big trouble to most manufacturers. Specific to the above shortcoming in current technology of existing oxytetracycline injections, we produce through the rapid, low-temperature and high-efficiency complexation process, with the produced oxytetracycline injections having the following advantages: good stability, long storage time under normal temperature: above 2 years under high temperature or low temperature, not discoloring, no muddiness, small toxicity, small side effects, small dosage, high efficacy, quick acting, and long acting.

Are there industry standards or national standards for the products? What are the specific standards or certificate of analysis (COA)?

Chinese Veterinary Pharmacopoeia, and announcements of the Ministry of Agriculture of the P.R.C. are standards widely adopted in the industry, which have specific provisions for physicochemical properties and detection methods.

What are the specific quality detection and appraisal methods for the products?

The main detection methods include infrared spectrophotometry, UV spectrophotometry, gas chromatography, melting point detection, disintegration detection, dissolution testing, titration, HPLC, pH, and microbiological method, etc.

Chinese and foreign regulators are increasing regulation on pharmaceutical enterprises. How can informatization of pharmaceutical production and GMP management help pharmaceutical enterprises in the aspect of compliance?

The informatization of GMP management enables the traditional production management to be more transparent, helps enterprise management find the crux that affects product quality and cost according to realities, improves plan real-time nature and flexibility, increases productivity, generates enterprise information system, facilitates the statistical analysis and mastery of product trends, enables effective prevention and supervision, normalizes veterinary drug production more, stabilizes pharmaceutical product quality, improves product safety, increases product available content and stability, and thereby improves enterprise competitiveness.

Patents of many pharmaceutical products start to expire from 2017, which means the arrival of spring for generic drugs. The synergetic development of generic drugs and innovative drugs are the future trend. Can you share your perspectives on this trend?

1. With more consistent quality standards, branded generic drugs will lose part of their value proposition, and the price differentials between branded and unbranded generic drugs will narrow.

2. Branded generic drug business growth will slow down due to payer pressure to reduce costs via the commoditization of the generic drug market.

3. A few dominant players and business models will emerge with the commoditization of generic drug markets.

A series of policies has been implemented over the year as the government accelerates the medical reform, such as clinical trial management. What role do you think those policies play in promoting drug R&D? What will be the impacts on the future of the pharmaceutical industry?

Promote the R&D and industrialization of ethnic drugs, promote the improvement of ethnic drug standards, and strengthen TCM intellectual property protection, to have enterprises leading in the traditional Chinese pharmaceutical industry in terms of process and technology access further policy support. Further promote the industrialization of biotechnologies with independent intellectual property, and promote the bioindustry to develop towards intensification and internationalization.

Significantly improve the scale economy level and industry concentration through support for the qualified and the strong, and the survival of the fittest in market competition. And the future development directions are expected to be: dominating by large pharmaceutical enterprises, supporting by small and medium-sized pharmaceutical enterprises, and joint development of various pharmaceutical enterprises, from the previous extensive development with quantity expansion to the intensive development with structure upgrading.

The 13th Five-year Plan of the Chinese Pharmaceutical Industry clearly mentions the transition of the pharmaceutical industry from “large” to “strong”. How do you deal with such transition?

The homogeneity of current products is serious, and the competition of enterprises is mainly the price war. Shimu has been focusing on new drug R&D in recent years. Depending on the agriculture and animal husbandry colleges and research institutes, it has specially hired two doctors and four professors as perennial technical adviser, and established long-term scientific research cooperation with China Agricultural University, Northwestern Polytechnical University, and Hebei Agricultural University. Playing a significant role in product R&D, clinical trials, and product use and promotion, etc., the strong technical force and solid company strength lay the foundation for perfect product structure and leading technology, and guarantee stable quality and significant curative effects. Regarding the major scientific and technological achievements and science and technology awards obtained in recent three years, the company has successfully won 5 scientific research project awards, published 1 representative paper, and applied for 3 patents with independent intellectual property. The new drug R&D and marketing as well as the differentiation with other companies guarantee the market of Shimu to constantly expand.

 “Made in China 2025” forebodes that quality management is the most important link in the rise of the Industry 4.0 tide of China. What are your methods in quality management?

The company has a complete quality system as required by GMP, including quality management system, self-inspection system, and validation system, as well as standards, detection methods, release system, and regular training, etc. for raw and auxiliary materials, packaging materials, and finished products.

Oxytetracycline Injection

Ivermectin Injection

Albendazole Tablets