Up to now, CDER has approved 41 new molecular entities, and the PDUFA deadline for 2 drugs falls in December. If FDA does not speed up the approval of new drugs in December, the number of new molecular entities approved in 2017 may be 41-43. Of course, the new drugs covered in this article are NDA or BLA accepted by CDER, and do not include CBER-reviewed varieties, such as CAR-T products. Compared with last year's 20 or so, this year is a bumper year. Of the 41 products that have been approved, 31 are approved for the first time in the world, 19 products have received priority review (P),13 have received breakthrough therapy certification (B),17 have received orphan drug qualification (O), and only 11 products except biological products are subject to standard review (O)
Release time:
2017-12-10
Trend 1: The Five Hegemons in the Spring and Autumn Period are a foregone conclusion. Who will fight for the Seven Heroes in the Warring States Period?
In 2017, with the acceleration of the listing and financing process of national chain pharmacies (the main board and the new third board) and the massive entry of various capitals (industrial capital, PE, VC, private capital), the merger and reorganization of chain pharmacies in China entered a blowout period, and the market concentration is rapidly increasing. At present, five national chain pharmacies, including Guoda Pharmacy, Yixintang, Common People, Yifeng and Haiwang Xingchen, have emerged in our country. Dashenlin from South China has shown strong catching-up strength after its listing on July 31, 2017. The recently released interim financial report shows that this year's sales are expected to exceed 7 billion. Under the leadership of Chairman Lan Bo, Jianzhijia from Caiyun has seized major markets in southwest and other places, and declared on May 26, 2017, issuing 53 million shares, raising the 0.509 billion amount. It remains to be seen whether Dashenlin and Jianzhijia can catch up and become the seven heroes of the Warring States.
Trend 2: The princes want to reclaim hegemony, try to compete with the strong dragon!
Compared with the spring and autumn five hegemony galloping, the strong momentum of horse racing enclosure, many local retail chains have been in the "silent" development, such as Gansu friends, back to jade civilians, Shijiazhuang emerging, Jilin pharmacy in the regional combat effect is remarkable, but also the mainstay of the regional retail market. However, with the disclosure of Shu Yu's civilian prospectus at the end of 2016, Shandong Lijian has received 0.6 billion capital blessing again. Gansu Zhongyou has cross-regional control of five chain stores in Zhejiang and Anhui provinces. The voice of local governors in the industry is also getting louder and louder, and the volume of 1 billion is no longer a problem for them. On the premise of persisting in ploughing the northwest and ensuring the leading position of the northwest, Gansu Zhongyou launched the grand strategy of "leading the country. Its biggest advantage is the possible premium space generated by its 51% acquisition of "cash + equity swap" holdings.
It can be seen that as the backbone of the retail market, local governors are also moving towards the capital market and trying to squeeze into the five hegemonies and seven heroes camp. Here, the author sends a sentence to Zhu Yuanzhang's national policy to think about: build a high wall, accumulate grain widely, and be king slowly.
Trend three: read only sage books, two ears do not hear things outside the window
According to the data, there are more than 440000 and 5886 chain enterprises in China, including 220000 chain drugstores and nearly 200000 single stores. It can be seen from this that apart from the five tyrants and the seven princes, there are still a large number of small and medium-sized chain enterprises and single stores. But what did these landlords and bosses do in 2017? The author has many small and medium-sized chain friends. Some friends said that this year is really busy. They participated in various forums, such as summit forums, industry trends, and studied what backdoor listings, share incentives, and brainwashing projects, and then no matter what kind of concept, No matter what kind of model, they have been transplanted to their own companies, but the performance of their pharmacies has declined. Why? Yan Zi made Chuzhong have such a saying: "Oranges born in Huainan are oranges, and those born in Huaibei are trifoliate orange. Leaves are similar, but actually taste different. Why? Water and soil are also different".
At present, there is a mainstream trend in the retail industry of pharmacies. The future way out for small and medium-sized chain stores and single stores seems to be acquisition except closure. Although the author has different views on this, we will not argue here. Let's start with the acquisition. The core of the purchase price of pharmacies is determined by profitability, and the layout and quantity of stores are also considered. So should we stop aiming too high, stir in spring and settle down to work carefully, give full play to your own advantages, return to the service essence of retail, improve the professional ability of pharmacy of employees, improve the ability of fine management of categories, and then feel at ease at home dressing, applying powder and fat, waiting for the price to sell, and getting married on the basis of merit.
Trend 4: The pharmaceutical supply chain is staggered and integrated, you have me and I have you.
The pharmaceutical supply chain consists of three major sectors: pharmaceutical companies, pharmaceutical businesses, and retail companies. The three sectors have different roles in the supply chain and are highly complementary. Jiuzhoutong has entered the pharmaceutical retail industry from the pharmaceutical business and has 911 direct and franchise retail chain stores so far. Jiangxi Wuzhou Pharmaceutical's "Yao Bang Guo Yao Tang" has 121 franchise stores. It is reported that he recently took a stake in a high-quality regional retail chain enterprise in Jiangxi to undertake all commodity logistics and distribution, while this enterprise also took a stake in the "Yao Bang Guo Yao Tang" to be responsible for the development of franchise stores. January 4, 2017, the 28th meeting of the sixth board of directors of Baiyunshan Company deliberated and passed the "Proposal on Participating in the Subscription of Yunnan Hongxiang Yixintang (002727) Pharmaceutical (Group) Co., Ltd.'s Non-public Issuance of A Shares". With its own funds of RMB 0.8 billion, it subscribed for the non-publicly issued A shares of Yunnan Hongxiang Yixintang Pharmaceutical (Group) Co., Ltd. (Yixintang) and became the third largest shareholder in one fell swoop. For this investment, baiyunshan explained that "in order to grasp the future development opportunities of the domestic pharmaceutical retail industry, strengthen cooperation with chain pharmacies to promote the sales of the company's pharmaceutical retail products in the southwest region."
As the state encourages and supports the establishment of large-scale logistics distribution centers and encourages the construction of third-party platforms, the author suggests that small and medium-sized chains can consider participating in cooperation with large-scale logistics in the region and hand over professional matters to professional people to do, thus greatly reducing back-office expenses and focusing on front-office sales.
Trend 5: Internet focus builds "prescription sources."Remote reviewer "third-party platform
Retail pharmacies have been facing two major technical problems: one is the shortage of prescription sources, and the other is the shortage of licensed pharmacists on the job. These two major technical problems are also facing operational risks at all times, just like a Damocles sword hanging on the head of each retail pharmacy owner.
In order to promote the transformation and upgrading of drug circulation, Cixi market supervision bureau has started the work of setting up Internet remote outpatient service terminals in retail pharmacies on the basis of the initial trial operation of four pharmacies. Up to now, there are 169 pharmacies that have confirmed the installation of the service terminal. This year, Cixi City, innovative "Internet medicine" model, in Ningbo to take the lead in the pilot implementation of the pharmacy Internet remote outpatient service terminal. After the service terminal is set up in the pharmacy, the two functions of remote outpatient service and external prescription can be realized. After the patients registered in the pharmacy through the real name registration of ningbo cloud hospital information platform, cloud hospital doctors provide remote outpatient services for patients by video and other means, and issue electronic prescriptions for patients who meet the indications.
The Internet remote outpatient service terminal in pharmacies not only facilitates the dispensing of medicines for the masses, but also relieves the increasing outpatient pressure of hospitals to a certain extent. In order to promote the transformation and upgrading of drug circulation, Cixi market supervision bureau has started the work of setting up Internet remote outpatient service terminals in retail pharmacies on the basis of the initial trial operation of four pharmacies. Up to now, there are 169 pharmacies that have confirmed the installation of the service terminal. Through the third-party platform to completely solve the pharmacy prescription source and the patient's hospital purchased drugs.
Recently, Chengdu Food and Drug Administration issued the notice of Chengdu Food and Drug Administration on expanding the pilot work of licensed pharmacists' remote pharmaceutical services and electronic prescriptions in the city's drug retail links (hereinafter referred to as the "notice"). The notice allows monomer pharmacies to voluntarily apply to participate in the pilot of licensed pharmacists' remote pharmaceutical services and electronic prescriptions, At the same time, third-party platforms are allowed to build independent licensed pharmacists' remote pharmaceutical service platforms.
The remote pharmaceutical service of licensed pharmacists is only a transitional way for retail pharmacies left over from history that are not equipped with in-store licensed pharmacists and a supplementary way for retail pharmacies equipped with in-store licensed pharmacists to provide pharmaceutical services outside the normal working hours of in-store licensed pharmacists.
Third-party platform companies can build their own third-party independent licensed pharmacist remote pharmaceutical service platform (hereinafter referred to as "third-party pharmaceutical service platform") to provide licensed pharmacist remote pharmaceutical services for retail stores. The third-party pharmaceutical service platform must set up a wholly-owned pharmaceutical retail enterprise of a company nature; At least 15 licensed pharmacists (including western medicine and traditional Chinese medicine licensed pharmacists) shall be equipped, of which the proportion of traditional Chinese medicine licensed pharmacists in the total licensed pharmacists shall not be less than 25%, and all licensed pharmacists equipped shall be registered with the pharmaceutical retail enterprise; the third-party pharmaceutical service platform and the retail single store shall sign an agreement to clarify the functions and responsibilities of both parties in terms of pharmacist consultation and drug quality. The software and hardware construction requirements of the front and back ends of the third-party pharmaceutical service platform shall be set according to the relevant standards for remote pharmaceutical service of licensed pharmacists in retail chain companies in document No. 29 of the municipal bureau. For a lot of monomer pharmacies to solve the licensed pharmacists not on duty business risk and reduce operating costs.
Trend 6: Subverting chronic disease management and reshaping core profits
In recent years, chronic disease management has become a hot trend in retail pharmacies. Chain stores around the country have set up special store planning areas, such as "diabetes life hall" and "chronic disease life hall", and implemented measures such as training "chronic disease management specialists" among employees and establishing health records of chronic disease members. However, the author found that the companies providing chronic disease management ultimately take "selling the commodities they provide" as the core of all services and operations.
Here we would like to talk about Mr. Baiting-Zhao Erkui, the originator of chronic disease management. Mr. Zhao saw the huge industrial chain of diabetes in 2001. He pioneered diabetes products as the core to provide staff diabetes knowledge training and patient medication guidance services, creating a domestic chronic disease management model. However, have we found that in the course of many years of practice, the rising chronic disease management company is still continuing Mr. Zhao's mode of operation, but for the shallow quality of the employees in retail pharmacies, how painful and basically impossible it is to train a professional chronic disease specialist. Moreover, for patients with chronic disease products who increasingly rely on and trust the prescriptions issued by doctors, it is very difficult for you to change patients' products, and it is easy to cause the patient's disgust and resistance.
The author believes that the current chronic disease management model is not suitable for all retail pharmacies. Perhaps large chains can implement it, but small and medium-sized chains whose basic personnel quality is not very professional should be carefully considered. The author thinks that we can take the prescription low-cost chronic disease knowledge health records as a way to attract customers, health care products (including Chinese patent medicine) as the core profit structure system, strengthen the staff health care for chronic disease prevention and control knowledge. This method is relatively easy to operate for small and medium-sized chain, for reference only.
Trend seven: pharmaceutical O2OThe two sides stand side by side, see who is in charge of the ups and downs in the future?
After 2015, the development of pharmaceutical O2O can be described as wolf smoke everywhere, industry giants and start-up companies have been diving high, want to seize the highest point of the market. However, in just over a year, the entire pharmaceutical O2O industry has undergone drastic changes. Baidu Medical Division, WeChat Smart Pharmacy and Ali Health have all deviated from the original pharmaceutical O2O route, and start-up companies have also shown a lack of stamina.
At present, the remaining advantages are fast medicine delivery and jingle fast medicine. The two "survivors" in the field of medicine O2O, fast-medicine delivery and jingle fast-medicine, have coincided with the expansion plan this year, rewriting the imperial map. There is a clear difference between fast medicine delivery and jingle fast medicine in the strategic layout of 24-hour medicine delivery. Jingle Express Medicine takes a 500-meter to 3-kilometer store to ensure delivery of the medicine to home in 28 minutes. The fast medicine delivery method is within 25 kilometers and is promised to be delivered in one hour. After the O2O winter, who can seize the market more quickly? Whether the two heroes will eventually stand side by side, just like Taobao and Jingdong, and whether they will merge and monopolize the market, just like Didi Chuxing and Uber China? We will wait and see.
Trend eight: brand product strategic cooperation, category management mainstream direction
In recent years, in order to increase sales and profits, retail pharmacies have adopted "single product breakthrough" or "category breakthrough", selected some small business products, and adopted the method of high commission for salespersons. It is true that they have made great contributions to the sales and profits of pharmacies. But according to the author in practice found that this way to the customer left a very bad impact, even some customers heard the staff recommend, immediately said: there is a commission? What are the products! I 've never heard of it, what do you really want to do? Employees often respond to these customers' complaints when they work on the front line, and they also feel that the products are becoming more and more difficult to recommend.
The author believes that the competitive trend of chain drugstores will change from "sales-oriented" to "customer-oriented". There is no problem in the breakthrough of single products. The main problem is the products selected. Chain drugstores must first start with the products recognized by customers and cooperate with the brand products of well-known brand enterprises in order to make the breakthrough of single products easier to operate and more acceptable to customers. The following are examples of cooperation between chain and brand enterprises in various regions.
Recently, Bayer Healthcare Co., Ltd. formally signed a strategic partnership with Fahrenheit Pharmacy, and the two sides will carry out in-depth cooperation in drug retail brand strategy in an all-round way. At the signing ceremony, representatives of both sides said that on the basis of good cooperation in the past years, they would carry out more comprehensive and deepening cooperation. According to the agreement, Bayer will cooperate with Fahrenheit Pharmacy to carry out various medical information communication at the terminal. Bayer will attach great importance to the business activities of Bayer products carried out by Fahrenheit Pharmacy.
On August 8, the strategic cooperation kick-off meeting of Qingdao Shuangjing Pharmaceutical Co., Ltd. and Ningbo Beilun Youhe Pharmacy Co., Ltd. was successfully held in Donggang Hotel, Beilun District, Ningbo City!
On February 23, 2017, Ms. Li Yunpeng, general manager of Tianjin Lisheng Pharmaceutical Co., Ltd., and a group of ten people visited the Shanghai headquarters of Sinopharm Holding Guoda Pharmacy Co., Ltd., a leading domestic drugstore chain. Lisheng Pharmaceutical and NUS Pharmacy reviewed the good cooperation for many years and discussed and analyzed the strategic cooperation in 2017. Participants from both sides witnessed the signing ceremony of the 2017 Strategic Cooperation Agreement signed by Mr. Zhao Xiaochuan, General Manager of National Pharmacy, and Ms. Li Yunpeng, General Manager of Lisheng Pharmaceutical, on behalf of both companies.
Trend 9: Chinese medicine clinics, new directions for future pharmacies
On September 22, 2017, the National Health and Family Planning Commission of the People's Republic of China issued the Interim Measures for the Administration of Filing of Traditional Chinese Medicine Clinics by Order No. 14. The "Measures" are divided into 5 chapters and 29 articles, including general provisions, filing, supervision and management, legal responsibilities, and supplementary provisions, and will come into force on December 1, 2017. The biggest highlight of this method is the change from the approval system to the filing system, and it is clearly stipulated that Chinese medicine clinics are under the guidance of Chinese medicine theory, using Chinese medicine and non-drug therapies such as acupuncture, cupping, and massage to carry out diagnosis and treatment services, as well as Chinese medicine dispensing, Decoction and other Chinese medicine pharmacy services. From the above two points, it is not difficult to interpret the country's policy of loosening the restrictions on the establishment of Chinese medicine clinics and releasing the good news of adding Chinese medicine service items to the medical insurance catalogue in the future, which can not only solve the prescription source of retail pharmacies, but also grasp the national health planning direction of Chinese medicine health preservation, and provide guarantee for increasing the category of Chinese medicine and Chinese medicine services. The author believes that the mainstream pattern of retail pharmacy standards of Chinese medicine stores in the future will be formed.
Trend 10: Rural urban health insurance merger, the number of designated pharmacies surge.
According to statistics, many provinces or social security areas across the country, including Zhejiang, Chongqing, Beijing, etc., have completed the integration of basic medical insurance for urban residents and the new rural cooperative medical system, and established a unified basic medical care for urban and rural residents. Insurance system. After the system is merged, urban and rural residents who are not covered by the basic medical insurance for urban employees, including rural residents and urban non-employed residents, can participate in the basic medical insurance for residents, and implement a unified medical insurance policy for urban and rural residents in the province to achieve a unified management Department, financing standards and information system. The new rural cooperative fund and the urban residents' medical insurance fund are unified into the urban and rural residents' medical insurance fund. In 2017, the medical insurance designated access will change the approval system into a comprehensive scoring agreement system, since the implementation of the agreement system, the medical insurance designated retail pharmacies have become a surge trend. Data show that the four major chain pharmacies medical insurance designated pharmacies are increasing, and its proportion is far more than ordinary pharmacies. The common people (77.9 per cent) topped the list, followed by Yixintang (77.6 per cent), Dashenlin (66.04 per cent) and Yifeng (62.3 per cent). In addition, medical insurance pharmacies in many places have also increased this year. For example, Shanghai increased by 100 in May this year. Yunnan passed the 214 applications of the previous year. Nanjing has only approved 648 in the past 15 years, and has added 694 since 2016, an increase of more than 15 years. Guangzhou Panyu District added 216 in 8 months. In 2018, with the acceleration of the reform process of the medical insurance system and the advancement of the integration of the two insurances across the country, the capacity of the medical insurance market will increase sharply. Actively striving for medical insurance designation will be the key work direction of retail pharmacies.