The heavy gold layout is difficult to obtain production qualification. The development strategy of the Chinese medicine formula granules of Zuoli Pharmaceutical has been frustrated.

The Chinese medicine formula granule policy has been revived.

On June 13, the Fujian Food and Drug Administration issued the "Notice on Further Strengthening the Supervision of Chinese Medicine Formula Granules." The notice stated that only Chinese medicine formula granule production enterprises approved by the former State Drug Administration were allowed to distribute products directly to the pilot medical institutions. Non-pilot medical institutions may not use them, and drug dealers may not operate Chinese medicine formula granules.

At the end of 2015, the State Food and Drug Administration issued the "Administrative Measures on Chinese Medicine Formula Granules (Draft for Comment)" (hereinafter referred to as "Draft for Comment"), and the sound of "regulation of Chinese medicine formula granules is released" for a time, the industry undercurrent A wave of public investment, including Zhejiang Zuoli Pharmaceutical Co., Ltd. (hereinafter referred to as "Zuoli Pharmaceutical", 300181.SZ), began to enter the formula pellet market.

It is understood that after the peak performance in 2014, the net profit of Zuoli Pharmaceuticals began to enter the downward channel. In order to reverse the decline in performance, in 2015, Zuoli Pharmaceuticals acquired a 51% stake in Baicao Chinese Medicine for 130 million yuan and cut it into the field of Chinese herbal medicines. However, Zuoli Pharmaceuticals did not have the qualification to produce pellets at the end of 2016. The plan to complete the development and production of more than 300 granules in 2016 is also facing many obstacles.

“The trend of the liberalization of the Chinese medicine formula granule industry is becoming increasingly clear, and the development of the Chinese medicine industry is welcoming the golden period of development.” Zuoli Pharmaceutical said in an interview with the “China Business News” that Fujian’s policy on the company’s Chinese medicine formula pellet production There is no impact on the use. “Chinese Herbal Pieces and Formula Granules are the key support and development direction of the Chinese medicine industry. It is only a matter of time for the state to release the Chinese medicine formula particles, but the specific timetable is not predictable.”

Heavy gold layout

The time goes back to December 24, 2015, the State Food and Drug Administration issued the "Draft for Comment", the most interesting thing is that the Chinese medicine formula particles will be released, March 1, 2016 is the deadline for comments .

The "Draft for Comment" was regarded as a harbinger of the liberalization of the Chinese medicine formula granule policy. In addition, the Zhejiang Provincial People's Social Welfare Department and the Chinese Medicine Administration also announced that the Chinese medicine formula granules were included in the medical insurance, and the Chinese medicine formula granules were set up in the industry. The boom in production layout.

For example, in July 2016, Taiji Group, Sichuan Kelun Pharmaceutical Trading Co., Ltd. and Enwei Pharmaceutical Co., Ltd. planned to jointly establish Sichuan Sanqiang Modern Chinese Medicine Co., Ltd. and signed the “Investment Cooperation Agreement on Modern Chinese Medicine Formula Granular Products Project”. . At that time, Xue Yongjiang, the president of Enwei Group, was quite representative in the interview with the media. "If we wait until the "Measures" is officially released, we will lose our initiative and opportunities."

Dolly Pharmaceuticals is unwilling to lose the initiative and opportunities. According to the company's statement, the research on the formulation of Chinese medicine formula granules, the construction of production lines and the future special research projects will help seize opportunities and expand the national market when national policies are fully liberalized.

It is understood that in 2015, Zuoli Pharmaceutical obtained a 51% stake in Zhejiang Baicao Traditional Chinese Medicine Pieces Co., Ltd. for 130 million yuan, cut into the field of traditional Chinese medicine decoction pieces, and invested 110 million yuan to accelerate the construction of Chinese medicine formula pellet production line project. In accordance with the plan of Zuoli Pharmaceutical at that time, more than 300 granules were developed and produced in 2016, and the formulation granule production qualification was obtained at the end of 2016, and production began in 2017.

However, after the renaming, Zhejiang Zuoli Baicao Chinese Herbal Pieces Co., Ltd. did not wait for the favorable release of the Chinese medicine formula granule policy in 2016, and the market supervision has been continuously strengthened. The reporter found that in August and September 2016, Beijing and Shandong Food and Drug Administration issued the "Notice on Strengthening the Supervision of Chinese Medicine Formula Granules" to reaffirm the pilot production of the clinical use of Chinese medicine formula particles, which should be the original national medicine. The Chinese medicine formula granule manufacturer approved by the Supervisory Authority.

According to the data, at present, China has implemented a pilot production system for Chinese medicine formula granules. The State Food and Drug Administration has approved the Shenzhen Sanjiu of China Resources Sanjiu, Tianjiang Pharmaceutical of China Traditional Chinese Medicine, Kangrentang Pharmaceutical of Hongri Pharmaceutical, and Peili. (Nanning) Pharmaceutical, Sichuan New Green Pharmaceutical and Guangdong Pharmaceuticals, and other six Chinese medicine formula granule trial production enterprises.

The expected policy liberalization has not yet arrived. This also means that although the Chinese medicine formula granules usher in the golden period of development, for most companies, it is “not visible to eat”.

According to the 2016 annual report, the first phase of the Zuol Pharmaceutical Chinese Medicine Formula Granule Production Line is planned to invest 110 million yuan. Last year, it has invested 501.948 million yuan and the project progress is 45.73%. However, the company has not prepared for this.

Will Zuoli Pharmaceuticals prepare for the impairment of the above-mentioned projects in the face of uncertainty in the liberalization of the Chinese medicine formula? Will the second phase of construction be affected?

In response, Zuoli Pharmaceuticals responded that the 2016 Chinese medicine formula pellet production line is still in the construction stage, and no impairment test is required and the impairment preparation is extracted. The second phase of the Chinese medicine formula pellet construction will be based on the first phase of the production capacity. Use the situation to determine. However, the company did not disclose the comprehensive utilization of the first phase of production capacity.

Different from Fujian's policy of strengthening supervision, on June 19th, Guangdong Province issued the “Guide to the Pilot Production of Chinese Medicine Formula Granules in Guangdong Province”, which means that the management of Chinese medicine formula granules is gradually loosened, allowing qualified production enterprises to declare and do A declaration guide.

The relevant person in charge of Sishen Medical Consulting Shanghai Co., Ltd. said in an interview that many of the policies of the national pharmaceutical industry are unified nationwide, but some places will also introduce some inconsistent or even contradictory policies. The regulatory policy for Chinese medicine formula is a Typical Case. "This is mainly because the country is currently in a wait-and-see attitude towards Chinese medicine formula granules. Does the people accept the use of traditional Chinese medicine formula granules, how to form a unified industry standard, and whether traditional Chinese medicine formula granules can lead the modernization of traditional Chinese medicine. These problems are academic. There is still controversy on the top."

Zuoli Pharmaceutical also stated in the reply that the Chinese medicine formula granules produced by the company are mainly used in medical institutions that meet the requirements in Zhejiang Province. The policies of Fujian Province have no effect on the production and use of the company's traditional Chinese medicine formula granules.

Declining performance

Based in the bio-fermentation technology of medicinal fungi, Zuoli Pharmaceutical Co., Ltd. is mainly engaged in the research and development, production and sales of medicinal fungi products, and has the qualification of high-tech enterprises. In 2016, the top three products of the company's revenue and distribution products were Wuling Series, Bailing Film Series and Chinese Herbal Pieces.

According to financial data, since 2015, the net profit of Zuoli Pharmaceutical has declined for two consecutive years. Among them, the company's total operating income in 2015 was 671 million yuan, a year-on-year increase of 30.28%, deducting non-net profit of 74.215 million yuan, down 22.78% year-on-year; in 2016 the company's total operating income was 840 million yuan, up 25.22% year-on-year, deducting non-net profit 5603.36 Ten thousand yuan, down 18.07% year-on-year.

Regarding the decline in net profit, Zuoli Pharmaceutical said that the main reason is that with the deepening of the national medical system reform, medical insurance control fees have been strengthened, including policies such as second bargaining, zero drug addition, drug ratio control, and marketing. The adjustment of the team brought some pressure on the sales growth of the company's products, and the growth rate did not meet expectations. At the same time, since 2014, in order to enhance competitiveness, the company has actively expanded its business structure around the upstream and downstream industries. The financial cost brought by the increase in investment has increased. It takes time for investment projects to improve the company's performance.

The reporter found out that in 2014, Zuoli Pharmaceuticals' non-net profit reached 96.10 million yuan, a peak in the past decade. Perhaps it is realized that the company's subsequent development will be limited. Since 2014, the company has expanded its business through epitaxial mergers and acquisitions while strengthening endogenous growth. The Chinese medicine decoction piece business and the Bailing film business have separately acquired the Chinese herbal medicines and Everest medicine came.

According to the 2016 annual report, the sales revenue of Zuoli Pharmaceutical's Chinese Herbal Pieces series was 169 million yuan, a year-on-year increase of 312.38%. Although the performance was outstanding, it was also related to the small base in 2015. At the same time, it completed more than 300 granule varieties in 2016. R & D and production, to achieve the qualification of formula pellet production at the end of the year, starting production in 2017, compared with the planning target, the Chinese medicine formula pellet business may not be as expected.

At the same time, the current development of the Zuoling and Bailing series, which are highly anticipated by the company in the 2017 business plan, is less than expected.

In the research brief issued by Guolian Securities in May 2016, Guolian Securities expects that the Zuoling Pharmaceuticals Wuling series is expected to resume the growth rate of 10%~15%, and the Bailing film series will maintain a high growth rate of around 50%. In the August research report, Dongxing Securities also gave similar growth for the two leading products for the whole year. However, the 2016 annual report shows that the exclusive product of the Zuoli Pharmaceuticals Wuling series fell 0.73% year-on-year, while the 27.18% growth rate of the Bailing film series was far below expectations.

In response to the reporter’s report on the sales growth of Wuling Capsule and the smooth promotion of Bailing Film in the hospital, Zuoli Pharmaceutical said that the company will focus on “going the trend, seeking the overall situation, strengthening the government, and complying with regulations and stability. Self-operated, strong investment, cloth retail, full module" marketing strategy concept, take advantage of the self-operated model, and at the same time upgrade the investment model from the vacancy position to the strategic marketing model, and strive to make Wuling Capsule and Bailing in the next few years. The film is developed into a large variety of modern Chinese medicine with annual sales of more than 1 billion yuan.

"In the future, the company will strengthen resource integration, exert endogenous growth, actively adjust marketing strategies, focus on self-employment and investment promotion, strengthen the coverage of hospital terminals and chain pharmacies, strengthen academic marketing and brand building, and promote performance growth." Force Pharmaceuticals said.

(Original title: Diffuse gold production is difficult to obtain production qualifications. The development strategy of Zuoli Pharmaceuticals Chinese medicine formula granules is frustrated)