John Yu Pharmaceutical merger or the birth of variable criticize then GMP certificate

Cao Coping Pharmaceutical (300199.SZ) previously disclosed assets reorganization object unexpectedly suspected criticize then GMP Certificate, thus its disclosed reorganization of assets may also be affected. October 8, Anhui Province Medicine centralized Procurement Service Center (hereinafter referred to as "Anhui Province drug Production Center") issued a notice, Gansu Cheng Ji Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as "the Ji Biological") in the province for 2014 of the basic drug use centralized tender procurement, to provide suspected counterfeit drug GMP certificate. According to the drug recruitment "Implementation Plan" (Anhui Medical Reform (2014)3), after research, the abolition of the Gansu-ji Bio-Pharmaceutical Co. If the parties have objections, the application for review can be made within 15 working days. And the formation of the Ji-Yu is the listed company, John Woo pharmaceutical industry previously disclosed assets reorganization object.　　From this, the John Woo pharmaceutical mergers and acquisitions into a biological or life variables. Forgery Certificate August 20, John Yu Pharmaceutical disclosed a major asset reorganization related announcements, the company intends to Gansu to the Jamie Bio-Pharmaceutical Co., Ltd. shareholders non-public shares and pay cash to 1.32 billion yuan to buy its 100% equity. John Yu Pharmaceutical in the merger notice said that the formation of the age of 2012 at the end of the new production capacity of 80 million frozen powder needles and 160 million small capacity injection production line construction project, has been accepted by the State administration of Food and Drug Administration of the on-site inspection. However, the catch is, because Anhui Province in this year's base drug bidding shield failed to pass the new version of GMP Certification enterprises, into the discipline is suspected to counterfeit fake GMP certificate to participate in the tender, and by Anhui Province, the drug-mining center public exposure. According to the relevant information of Anhui provincial drug-mining center, there are 30 tablets and one Powder injection (0.1G) for injection. According to the "China Business newspaper" Reporter understands that the first half of the company has passed a new version of GMP certification. John Yu Pharmaceutical in September 3 evening notice, August 29, 2014, the State administration of food and Drug Supervision and Inspection Center in its official website bulletin "Drug GMP Certification Review Publicity (number 58th)." The National Food and Drug Administration Inspection Unit from August 12, 2014 to August 15 for the formation of biological small capacity injection and freeze-dry powder injection production line has been on-site inspection. The State administration of food and Drug Supervision and inspection Center by the on-site inspection and audit that the formation of biological small capacity injection and freeze dry powder injection production lines in line with the "Drug production Quality Management norms (2010 revision)" and publicity, publicity period of 10 working days, from August 29, 2014 to September 12, 2014. That is to say, as of September 12, the new GMP Certificate of frozen Powder injection has not been obtained. The reporter further notes that September 28, the state Food and Drug Administration issued the "Drug GMP Certification Bulletin (29th)" Information Show, "Drug GMP Certification Review Publicity (number 58th)" Publicity of the same batch of 22 enterprises, Shanghai Kaimo Bio-Medicine LimitedCompanies such as 21 pharmaceutical manufacturers have obtained GMP certificate, but the Jamie Biological did not pass the certification, the reason is unknown. Industry insiders told reporters, Anhui Province drug-mining center, "on the shielding part of the bidding product information" provisions, June 18 before the blood products, injections and other sterile drugs have not passed the new version of GMP certification Enterprises, in principle, can not participate in the 2014 public medical institutions in Anhui Province, the basic drug use of centralized tender and the formation of biological powder injection is a single phosphoric acid adenosine in the tender for the shortlisted, which means that the company suspected of forging frozen powder injection of the new version of GMP certification to participate in the bid. A third party evaluation agency issued the John Woo Pharmaceutical asset Appraisal report said that the formation of the species in the profit forecast, the department of the bio-biological September 30, 2014 through the injection of GMP certification for the assumption. After the calculation, if the time to obtain injection GMP certificate for the period of 1 months, 2 months and 3 months, the annual forecast net profit of 2014 will be reduced by 6.5806 million yuan, 13.1613 million yuan and 19.7419 million yuan respectively, accounting for the existing 2014 forecast net profit ratio is 6.47 %, 12.93% and 19.4%. The intriguing thing is, John Yu Pharmaceutical high-profile announcement of the reorganization of the company's new GMP certification Department of the publicity period, why did they fake GMP certificate to participate in the bid is not mention? John Yu Pharmaceutical response to this reporter said, in Anhui Province, the site of the drug-mining center, and did not find any notice of the Gansu Ji Biological. Therefore, the John Woo pharmaceutical industry will not carry out any relevant open letter.　　After the reporter to the John Yu aspect of Anhui Province to provide drug-mining center site of the above circular, the company also said that at present we have not received any notice. Suspicious inquiry even more surprising is that, October 11, founder Securities published the title of "John Yu Pharmaceutical: Anhui Bidding events have no impact on the performance, continue to optimistic about" the research paper. The study said that the incident is a local agent for the completion of sales tasks, the unauthorized submission of false materials, completely belong to the agent's personal behavior. Anhui Province in the first half of the drug tender requirements: June 30 through the new version of GMP Enterprises can bid. Cheng creature shortlisted for the first half of the 30 tablets has passed a new GMP certificate, no problem. But the first half of powder injections did not pass the new version of GMP, agents are lucky, leading to this event. The reporter has consulted the recent announcement of the John Yu pharmaceutical industry and its reply in the Shenzhen Stock Exchange [micro-blog] interaction easily, the company currently has no explanation to the Anhui tender matter. Then founder of the Securities Research Report on the incident is entirely part of the agent's personal behavior of the argument from where? The research report rarely discloses the next step that the company is not disclosing. Founder Securities said that the Anhui Province, the foundation of the drug tender, into the age of the products have 30 tablets and a powder injection, due to the implementation of the lowest price in Anhui, the actual successful award of the species few. Cheng biological drugs in the past in Anhui Province sales are very small, no impact on performance. Solid systemAgent is the first half of the year into the new varieties, 1 ~ June nationwide sales of only 1.53 million yuan, no sales in previous years; Most of the injections are not based on drugs. John Yu Pharmaceutical after the intervention into the JI biological, will be more standardized its market behavior, strengthen the management of agents. Founder Securities judged that the incident will not happen again, and said that the Ji-life will also actively strengthen communication with the recruitment center in Anhui province, to ensure that the future of Anhui's non-base drug bidding will not be affected. Is there any suspicion that the securities firm's inquiry is out of bounds? Shanghai Hua Rong law firm Xu Feng lawyer said, founder Securities This research newspaper "over the boundary", there is a suspicion of leaking inside information. and mergers and acquisitions marked by a major flaw, may lead to mergers and acquisitions failure or adjustment; This will have a significant impact on the investment decisions of the John Woo pharmaceutical industry, and the listed companies should disclose them in time.　From September 16 to October 15, a short period of one months, founder Securities published 3 optimistic about John Yu Pharmaceutical research paper. An EIA lag? August 19, John Yu Pharmaceutical in the merger notice said that the formation of biological now in accordance with the new version of GMP requirements for the completion of frozen powder needles, small capacity injection production workshop new work, and from August 12, 2014 to 15th received the State administration of food and Drug Supervision Organization of the GMP on-site inspection. The reporter found that June 27, the Tianshui Environmental Protection Bureau released the "Gansu Cheng Ji Bio-Pharmaceutical Co., Ltd. to expand annual production capacity of 80 million frozen powder needle line and 160 million small capacity injection production line construction project publicity" shows that the proposed project is located in Gansu province Tianshui area 20 industrial Park, The nature of construction is reconstruction and extension; This project mainly carries on the interior decoration and the equipment installment to 1 freezing powder injection workshop, carries on the interior decoration and the equipment installment to 1 small capacity injection workshop, the reconstruction Extension power distribution room, the boiler room and so on auxiliary production project, the project total investment 94.8 million yuan, in which the fixed assets investment 85.3 million yuan, Bedding liquidity 9.5 million yuan. The public announcement time is June 27, 2014 to July 6, 2014, the publicity period is 10 days. According to an EIA engineer in Anhui Province, environmental impact assessment refers to the analysis, prediction and evaluation of the environmental impacts that may result from the implementation of the planning and construction projects, the countermeasures and measures to prevent or mitigate adverse environmental impacts, and the methods and systems for tracking and monitoring. The 25th article of the People's Republic of China Environmental Impact Assessment Law stipulates that the environmental impact assessment documents of the construction project are not approved by the examination and approval department after the examination or examination by the law, the project approving Department shall not approve its construction, and the construction unit shall not start the building. In other words, Gansu Cheng Ji Bio-Pharmaceutical Co., Ltd. expansion of annual output of 80 million frozen powder production line and 160 million small capacity injection production line construction project only after the publicity through the Environmental Protection Department approval, can start construction. Industry insiders told reporters that at present, the drug regulatory Department of GMP certification and environmental protection departments of the environmental assessment is independent of each other, GMP certification inspection of the enterprise whether the completion of the EIA acceptance certificate has no clear requirements, only the Environmental monitoring Department issued the Waste water, waste residue, waste gasEmission-qualified monitoring reports. However, the above-mentioned projects such as not through Environmental Protection Department EIA approval, trial production approval, even through the GMP certification, the risk is huge, the local environmental Protection Department found this situation, will stop production and punish it. John Yu Pharmaceutical to this explanation said, December 8, 2011, the relevant departments have been to the formation of the age of the 2012 at the end of the new production capacity of 80 million frozen powder needle line and 160 million small capacity injection production line construction projects to make environmental impact assessment publicity. June 27 This year's publicity, is the company in strict accordance with the relevant provisions of the renewed application for a perfect update, is the material update, does not have any environmental assessment lag behavior. At present, the project has been approved by the local environmental protection regulatory authorities.