Guotai Junan Securities Co.Ltd(601211)
about
Guangdong taienkang Pharmaceutical Co., Ltd. initial public offering and listing on the gem
Listing recommendation
Sponsor (lead underwriter)
No. 618, Shangcheng Road, China (Shanghai) pilot Free Trade Zone
January, 2002
Guotai Junan Securities Co.Ltd(601211)
About Guangdong taienkang Pharmaceutical Co., Ltd
Shenzhen Stock Exchange:
Guotai Junan Securities Co.Ltd(601211) (hereinafter referred to as “sponsor” ” Guotai Junan Securities Co.Ltd(601211) securities”) accepted the entrustment of Guangdong taienkang Pharmaceutical Co., Ltd. (hereinafter referred to as “issuer”, “taienkang” company “) to act as the sponsor of taienkang’s initial public offering of shares and listing on the gem.
In accordance with the company law of the people’s Republic of China (hereinafter referred to as the “company law”), the securities law of the people’s Republic of China (hereinafter referred to as the “Securities Law”), and the measures for the administration of the registration of initial public offerings on the gem (for Trial Implementation) (hereinafter referred to as the “measures for the administration of registration”) In accordance with the relevant provisions of the measures for the administration of securities issuance and listing recommendation business (hereinafter referred to as the “measures for the administration of recommendation business”), the guidelines on the content and format of the recommendation letter for GEM Listing of Shenzhen Stock Exchange, the Listing Rules of gem shares of Shenzhen Stock exchange (hereinafter referred to as the “Listing Rules”), the recommendation institutions and recommendation representatives are based on honesty and trustworthiness With the professional spirit of diligence and responsibility, this listing recommendation letter is issued in strict accordance with the business rules and industry self-discipline norms formulated according to law, and the authenticity, accuracy and completeness of this listing recommendation letter are guaranteed.
Unless otherwise specified in this listing recommendation, relevant terms have the same meaning as in the prospectus of Guangdong taienkang Pharmaceutical Co., Ltd. for initial public offering and listing on the gem.
Section 1 basic information of the issuer
1、 Basic information
Guangdong taienkang Pharmaceutical Co., Ltd
English Name: Guangdong taienkang Pharmaceutical Co., Ltd
Date of establishment: January 22, 1999
Legal representative: Zheng Hanjie
The registered capital is 177287500 yuan
Paid in capital: 177287500 yuan
Registered address: building a, No. 8 Wanji south 2nd Street, Taishan North Road, Longhu District, Shantou
Postal Code: 515041
Tel: 075488847515
Fax: 075488847519
website http://www.tai-kang.com.cn.
E-mail [email protected].
Pharmaceutical trading; Food sales; Operation of medical devices; Sales: disinfection supplies, daily necessities, business scope cosmetics; Import and export of goods and technology. (for projects subject to approval according to law, business activities can be carried out only after approval by relevant departments)
2、 Main business
The company is a comprehensive pharmaceutical company in the pharmaceutical industry. The company’s main business is agency operation, R & D, production and sales of pharmaceutical products, medical devices and sanitary materials, and the provision of pharmaceutical technical services and technology transfer. According to the guidelines on industry classification of listed companies issued by the CSRC, the industry of the company is wholesale industry.
3、 Core technology and R & D level owned by the issuer
(I) core technology
1. Independent research and development of core technologies related to drugs
With the goal of becoming an innovation driven comprehensive pharmaceutical enterprise, relying on the stable cash flow generated by agency operation business, the company takes independent drug research and development as a key measure to improve its core competitiveness. According to the resumes of the core personnel of the drug R & D team, the majors of relevant personnel include “chemistry, synthesis direction of small molecules and carrier excipients”, “drug preparation, construction direction of functional carrier excipients and targeted drug delivery system”, “chemical biology”, “organic chemistry”, “pharmacy”, “chemical engineering and technology”, etc, The company has established a core R & D team composed of technicians in the fields of chemical raw materials, chemical agents and biological drugs, with certain pharmaceutical R & D capabilities. The company has established three pharmaceutical R & D technology platforms: functional excipients and key technology platforms for nano drug delivery; Key technology platform for Biomacromolecule drugs and technology platform for generic drug development and consistency evaluation.
(1) Functional excipients and key technology platform for nano drug delivery
At the beginning of its establishment in 2015, Shandong Huabo Kaisheng was committed to building a key technology platform for functional excipients and nano drug delivery, and mastering the technologies related to the development of nano polymer micelles through this technology platform, so as to develop a series of high-end improved new drugs. Special drug delivery system is mainly used to improve the solubility of drugs and the distribution of absorbents in vivo, including special dosage forms such as lipid microspheres, liposomes and nano polymer micelles. In the special drug delivery system, the high permeability and retention effect of solid tumor can be produced due to the entry of nano polymer micelles into the body, so as to improve the curative effect and reduce the toxic and side effects of drugs.
In 2018, docetaxel polymer micelles for injection (chemical drugs category 2.2) independently developed by the company obtained clinical trial approval, which is the first enterprise in China to obtain clinical trial approval for docetaxel polymer micelles for injection. In the same year, the company signed the transfer contract of docetaxel polymer micelles for injection project with Shanghai kaimao, a holding subsidiary of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (securities code: Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ). The company exclusively transferred the clinical approval and relevant intellectual property rights of “docetaxel polymer micelles for injection” in China to Shanghai kaimao, which is responsible for the subsequent clinical development and Declaration of production approval, product production and sales, and bear the expenses of relevant links. The company will receive the return of “down payment + milestone payment + future sales commission”. At present, the phase I clinical trial is about to be completed.
At present, the main drugs under development of the platform are docetaxel polymer micelles and excipients for injection, cisplatin polymer micelles and excipients for injection, paclitaxel polymer micelles and excipients for injection.
(2) Key technology platform of biological macromolecular drugs
The key technology platform of biological macromolecular drugs is to prepare macromolecular drugs from microorganisms, cells, various animal and human tissues and liquids obtained by biotechnology such as fermentation engineering, cell engineering and protein engineering.
The technology of the platform is mainly reflected in the high-efficiency expression technology platform of E. coli, the technology platform of glycosyl engineering Pichia pastoris and the phage display technology platform.
E. coli high expression technology platform is a new protein drug high expression system based on E. coli, which can partially replace the expensive mammalian cell expression system. Glycosyl engineering Pichia pastoris technology platform is an expression system that uses Pichia pastoris to replace mammalian cells to express glycoprotein drugs. It is used for the R & D and production of recombinant protein drugs or antibody drugs with glycosylation modification. Its advantages are mainly reflected in the aspects of short production cycle, low cost and easy industrial amplification. Phage display technology platform is a method system that uses phage display technology to screen humanized antibody sequences. The antibody sequences obtained by this method are all human antibodies, which lays a foundation for the research and development of antibody drugs in the future.
(3) Generic drug development and consistency evaluation technology platform
The technical platform for generic drug development and consistency evaluation mainly focuses on the research and development of generic drugs with market value. The research and development of dapoxetine hydrochloride tablets have been completed and the drug registration approval has been obtained. The company’s “aiting Jiu” dapoxetine hydrochloride tablets are the first similar varieties in China to be declared according to category 4 chemical drugs and approved according to the requirements of quality consistency evaluation with the original research, It is the “first imitation” in China, and its quality and curative effect are the same as those of the original drug. At present, the main drugs under development of the platform are pramipexole hydrochloride sustained-release tablets, tadalafil tablets, etc.
The core technologies related to drugs independently developed by the company come from Shandong Huabo Kaisheng and its members.
2. Core technology of production process
In the R & D and production practice in the fields of drugs, medical devices and sanitary materials, the company adopts reasonable and scientific quality management methods, deeply understands the product production process, and forms a number of advanced manufacturing processes and technologies, mainly including traditional Chinese medicine crushing process, traditional Chinese medicine extraction process, pill making process, drying process, filling process, packaging process, cotton core production process Quality research, cotton swab production process, mask ear belt welding process, mask punching process, etc. the relevant core technologies are mature and stable. The core technology of the company’s production process comes from the independent research and development of the company and its subsidiaries.
As of the date of issuance of this listing recommendation, the company and its subsidiaries have 134 patents, including 12 invention patents, 116 utility model patents and 6 design patents.
(II) projects under research of the issuer
1. Independent research and development
The company has a professional R & D management team and has the ability to independently select topics and establish projects, conduct information research, develop projects, and apply for registration. As of the signing date of the listing sponsor, the independent R & D projects and progress of the company are as follows:
Main R & D projects of the company and their investment from 2018 to January June 2021:
Accumulated investment in the progress of indications by serial number code category during the project reporting period (10000 yuan)
Received from the State Drug Administration in July 2019
Hk036 application for approval document of drug registration of supervision and Administration Bureau
(acceptance notice of hydrochloric acid for the treatment of idiopathic Parkinson’s disease; received in April 2020)
1. The signs and symptoms of pramipek chemical class 4 Kinson’s disease shall be supplemented with 892.88 Suo sustained-release form by the State Drug Administration, which shall be notified separately or with levodour information; Submitted in August 2020
(1) supplementary information of Pakistan United use; November 2020
Know about on-site inspection; End of May 2021
On site verification
Hk001 received the National Drug Administration in May 2020
2 (nitrofurans, class 4, are used to treat gynecological inflammation. The clinical trial notice of the supervision and Administration Bureau of gynecology 267.67 taieryin book; it was approved in September 2020
Track piece
Three batches of pilot test and process research have been completed for the treatment of gastrointestinal tract
3. Too much gas is accumulated in hk013 chemical class 3; Methodological studies and studies on the stability of discomfort symptoms caused by 133.20 are being prepared
For the treatment of gastrointestinal tract, small-scale research and a batch of pilot trials have been completed
4. Excessive gas production is accumulated in Category 4 of hk014 chemical drugs; Discomfort caused by ongoing pilot study 128.44
Hk018 has completed pilot study, pilot study
5 (Class 4 of Tada chemical drugs is used to treat male erectile be; 844.82 Lafayette dysfunction was submitted in November 2020. Application materials
Film)
For children over 1 year old
Prevention and long-term treatment of asthma
Treatment, including prevention during the day
And asthma symptoms at night,
The treatment is sensitive to aspirin
Patients with asthma and
6 hk025 chemicals class 4 prevention of exercise-induced bronchitis has completed pilot study 275.34 tracheal contraction. This product is suitable for
Used to relieve allergic rhinopathy
