Anke biological acquires a new drug of burn and scald, freeze-dried recombinant human keratinocyte growth factor-2

In order to purchase the new KGF-2 for burn wound healing, Anke biology announced that it would invest in Anhui xinhuakun Bioengineering Co., Ltd (hereinafter referred to as xinhuakun), purchase 100% rights and interests of KGF-2 products from Wuhan Optical Valley xinshengyuan, and own all ownership of KGF-2 project including technology, technical secret, technology application right, patent, etc The registered capital of xinhuakun is 55 million According to the introduction of Anke biology, KGF-2 is an internationally recognized skin wrinkle removing and anti-aging factor It can specifically promote the proliferation, differentiation and migration of epithelial cells by acting on receptors on the membrane of epithelial cells, stimulate and improve the ability of cell synthesis Therefore, KGF-2 has multiple applications in the treatment of superficial skin burns, ulcers and beauty In terms of qualification, KGF-2 is a new class of national biological products, mainly used to promote burn wound healing At present, the product has two invention patents, completed phase II clinical and production technology, quality standard research and other related work, and has started phase III clinical research, and obtained the ethical approval from Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College, the project leader KGF-2 also has a good therapeutic effect on diabetic ulcer, pressure ulcer, mucositis, inflammatory bowel disease, venous ulcer, acute lung injury / acute respiratory distress syndrome, high altitude pulmonary edema and other diseases Although KGF-2 has powerful functions, it is worth noting that at present, the product is still in the stage of research and development After the clinical trial, it is still necessary to apply to the State Food and Drug Administration for production, obtain new drug certificate, production approval and GMP certification in the workshop before it can be engaged in pharmaceutical production and sales During the establishment of xinhuakun, in addition to 22 million yuan from listed companies, 16.5 million yuan from Shanghai xinshengyuan Pharmaceutical Group Co., Ltd and Xiao Jian, nine senior executives, including song Lihua, chairman of the board of Anke biology, also contributed 16.5 million yuan, accounting for 30% of the shares In this regard, Anke Bio said that there are certain risks in the application of new drugs Xinhuakun's participation of some managers of the company can reduce the investment risk of the company and make some managers of the company share the risk with the company In addition, Arco said that when the KGF-2 product of xinhuakun is ready for production, Arco will acquire all the equity of xinhuakun company held by Party B by issuing shares to purchase assets or cash or a combination of the two as soon as possible Arco will directly hold 70% of the equity of xinhuakun company Anke said that the application of recombinant human growth hormone in the field of burn and scald has occupied a leading position in China, and the introduction of KGF-2 will further enrich the company's product line Anke biology: Announcement on the establishment of a holding company jointly funded by the company and some managers of the company to purchase the lyophilized recombinant human keratinocyte growth factor-2 products and carry out research and development and related party transactions securities code: 300009 securities abbreviation: Anke biology Announcement No.: 2014-007 Announcement of Anhui Anke Bioengineering (Group) Co., Ltd on the establishment of a holding company jointly funded by the company and some management personnel of the company to purchase lyophilized recombinant human keratinocyte growth factor-2 products and carry out research and development and related party transactions, There is no false record, misleading statement or major omission The third meeting of the 5th board of directors of Anhui Anke Bioengineering (Group) Co., Ltd (hereinafter referred to as "Anke biology or company"), On February 24, 2014, the fifth meeting of the Fifth Board of supervisors deliberated and passed the proposal on the company and some management personnel of the company jointly funded the establishment of holding company to purchase freeze-dried recombinant human keratinocyte growth factor-2 products and carry out research, development and related transactions, and the proposal on the company's planned acquisition of part of the equity of the holding company (Preparatory) It is agreed that Anke biology and some of its management personnel, together with Shanghai xinshengyuan Pharmaceutical Group Co., Ltd and Xiao Jian, intend to establish a company in cash with the tentative name of Anhui xinhuakun Bioengineering Co., Ltd (hereinafter referred to as "xinhuakun company"), and the final name shall be subject to the industrial and commercial registration Xinhuakun company will purchase 100% rights and interests of lyophilized recombinant human keratinocyte growth factor-2 products from Wuhan Guanggu xinshengyuan company The details are as follows: 1 Project overview 1 Basic information project name: classification of new drug registration of freeze-dried recombinant human keratinocyte growth factor-2 (hereinafter referred to as KGF-2): clinical indications for application of class I new drug of national biological products: promoting wound healing for burn wound Domestic stage: the first indication (shallow Ⅱ ° burn) is in the phase III clinical trial supported by the national project: "11th Five Year Plan" national major new drug creation special project patent situation: the production process of this project has obtained two invention patent certificates (zl02110 * * 0; 200510027 * * * 4), all of which have been authorized Mode of production: gene engineering method and E.coli Expression System Wuhan Guanggu xinshengyuan biomedical Co., Ltd (hereinafter referred to as: Wuhan Guanggu xinshengyuan) owns all the ownership of KGF-2 project including technology, technical secret, technology application right, patent, etc At present, the project has completed the phase II clinical and production technology, quality standard research and other related work, and the phase III clinical research has been started, and obtained the ethical approval from Ruijin Hospital Affiliated to Shanghai Jiaotong University Medical College, the project leader 2 The research and development of KGF-2 shows that the sale of burn and scald drugs in the retail market is on a steady rise according to the data of "China drug retail monitoring and analysis system" (RDM system) of Guangzhou punctuation pharmaceutical information of SFDA South pharmaceutical Economic Research Institute At present, there are many kinds of drugs for treating burn and scald in the market, and the market competition is also fierce, mainly including Chinese and Western medicine and biological products (repair factors) However, they have their own characteristics and limitations, and their application fields are not the same Correspondingly, they also have their own unavoidable defects, but in general, the development of biological products, In particular, the new generation of wound repair factor products that can avoid scar formation is one of the development trends of burn medicine KGF, It is a hot spot of International Cytokine drug development (as shown in the table below) Company's product name R & D stage indications for venous ulcers, cancer treatment has been completed, phase III of the American human Genome Corporation RepiTermin treatment of mucositis and bed failure test for chronic ulcerative colitis, chronic diabetes in Germany, Yang Sen sielage Becaplermin gel has been listed on the role of ulcer healing, the US Amgen Kepivance intravenous injection has been listed For the treatment of oral mucositis (KGF-1), we have completed the preclinical study on corneal epithelial defect and recombinant human keratinocytes from the biological Department of gerust in Zhejiang Province, Long factor-2 eye drops of mild to moderate dry eye disease, corneal erasure Technology Co., Ltd are ready for injury, corneal ulcer and other ind application before the application of recombinant human keratinocyte for injection in Zhejiang gerust biology department (preliminary pharmacodynamic cavity mucositis research on the cytogrowth factor modified structure of Stomatology Co., Ltd caused by radiotherapy and chemotherapy of cancer has been completed, and is being entered into the affiliated Fudan University Pre clinical study on the growth of recombinant human keratinocytes in Zhongshan Medical Group (completed acute lung injury (ALI) / urgent Pharmaceutical Research) the pharmacognosy and pharmacodynamic hospital factor-2 pulmonary inhalant Research (ARDS) the third phase clinical trial of Wuhan Guanggu new source biological freeze-dried recombinant human keratinocytes shallow Ⅱ ° Burn Medicine Co., Ltd production factor-2 Wuhan Guangyuan The clinical data show that KGF-2 has good effects in the treatment of diabetic ulcers, pressure ulcers, mucositis, inflammatory bowel disease, venous ulcers, acute lung injury / acute respiratory distress syndrome, high altitude pulmonary edema and other diseases -2 Therapeutic effect 3 The project features: 1) no serious adverse events and good safety tolerance It can be widely used in all kinds of skin and corneal injuries, with a wider range of action than EGF and FGF 2) It has the function of promoting wound healing: KGF-2 molecular weight is smaller than EGF, aFGF and bFGF, it can enter into the skin faster, the curative effect is faster, and it can maximize the biological activity The patient's compliance was good, and the laboratory study indicated that it would not cause new organ damage, suggesting that the drug was safe and reliable to use the test dosage form under the test dose; the low-dose group was better than the high-dose group and the blank dose group in the time of complete wound healing (the complete healing within 10 days of superficial II ° burn wound has an important significance); compared with the blank control group, the high-dose group found that: the drug group The fixed phase healing time and complete healing time were significantly better than the blank control group (PPS analysis), which verified the effectiveness of the product 3) The results showed that KGF-2 could regulate early wound healing, reduce scar formation, regulate the distribution of melanin in wound skin, reduce pigment deposition, accelerate the repair of damaged hair follicles and restore the excretion function of wound Compared with other growth factors, KGF-2 could not lead to excessive epithelial proliferation, effectively reduce neutrophil infiltration and inflammatory reaction in local wound, It has remarkable characteristics in similar products 2、 Name of counterparty: Wuhan Guanggu xinshengyuan biomedical Co., Ltd address: Service Center of small and medium sized enterprise park, Gaonong road biomedical park, Donghu New Technology Development Zone, Wuhan (A-7 building) legal representative name: Liu Tao registered capital: forty four million yuan only paid in capital: forty four million yuan only company type: limited liability company Business scope: technology development, technology transfer, technology consultation and technical services in the field of drugs, biological products and medical devices, and engaged in the import and export business of goods and Technology (involving administrative license and operating with license) Wuhan Guanggu xinshengyuan biomedical Co., Ltd is a joint stock company of Shanghai xinshengyuan pharmaceutical Group Co., Ltd 3、 Introduction to relevant subjects and capital contributions of the holding company established this time 1 Address of Anhui Anke Bioengineering (Group) Co., Ltd.: k-1, Customs Road, high tech Zone, No 669, West Changjiang Road, Hefei city; name of legal representative: Song Lihua; registered capital: two hundred forty-one million nine hundred and sixty-five thousand eight hundred and fifteen yuan only; Paid in capital: 200 million, 100 million, 100 million yuan, 100 yuan, 100 yuan, and 100 yuan; the company type: Limited by Share Ltd (listing); business scope: self developed, produced biological products, medicine (genetically reconstituted products, gel, The validity of drug production license is December 31, 2015) and the export of raw materials and biochemical products, as well as the import of raw and auxiliary materials, mechanical equipment, instruments and components related to the company's production and scientific research (except for special provisions); drug and reagent diagnosis (Class III: in vitro diagnostic reagents, The valid period of the license for medical device manufacturing enterprises is until August 23, 2017), the research, production, sales, technology transfer and service of raw materials and products of biotechnology and Biochemical Engineering (those requiring the license in the above business scope shall operate with the license).