Fist products 50 million yuan transfer into the pharmaceutical industry or for the turnaround?

Recently, Shuangcheng Pharmaceuticals disclosed that it intends to sell the company's rights to inject more than 50 million yuan, the transaction is expected to increase the company's profit of about 37.5 million yuan, the 2019 net profit attributable to shareholders of listed companies has a greater impact. The heavy-weight products were transferred as soon as they were approved, and Shuangcheng Pharmaceuticals received a letter of concern from the Shenzhen Stock Exchange.Due to the previous three consecutive years of non-net profit deduction, Shuangcheng Pharmaceuticals this move is seen as reversing the loss situation to avoid the risk of de-market. Due to the multiple adverse effects of intensified competition in the main product market, single product structure and long-term equity investment failure, Shuangcheng Pharmaceuticals has been in a performance dilemma for a long time, and Bival Luding was once regarded as the key to change.Will the sale of the bivalding rights affect the follow-up operation of the dual-form pharmaceutical industry? How will the company respond? Shuangcheng Pharmaceuticals Secretary told reporters that the relevant matters will be in the Shenzhen Stock Exchange's letter of concern in response to the disclosure, all information is based on disclosure.

new product FDA was approvedOn December 3, Shuangcheng Pharmaceuticals disclosed the company's announcement that it had signed the Agreement on the Transfer of Product Rights, and that the Company intends to grant Suzhou Yiye Pharmaceutical Co., Ltd. (hereinafter referred to as "Two Leaf Pharmaceuticals") the right to own certain intellectual property rights and production technologies related to the injection of bivaldes in the designated area for 50 million yuan. The agreement was signed and implemented, which is expected to increase the net profit of listed companies by about 37.5 million yuan.It is understood that bival reed is a reversible specific clotting enzyme inhibitor. The evaluation of the target of this transaction uses the revenue method, the value of the proprietary technical assessment is 45.14 million yuan.In fact, Shuangcheng Pharmaceuticals just received the "Drug Registration Approval" issued by the State Drug Administration in January this year, and in May this year, it received the "Drug GMP Certificate" issued by the Hainan Provincial Drug Administration. Upon completion of this transaction, Shuangcheng Pharmaceuticals will transfer all product rights in China, including but not limited to commercial rights, free production rights, brand publicity, product redeve development and other rights, Shuangcheng Pharmaceuticals will no longer have any other rights over the product, except for continuing to hold the production approval number of the product, accepting and solely producing the product for Two Leaf Pharmaceuticals.Bivalding had high hopes for the double-form pharmaceutical industry. In December 2016, Shuangcheng Pharmaceuticals filed a generic drug registration application (ANDA) with the FDA and received provisional approval in May 2018. In April this year, the FDA conducted a comprehensive CGMP (current drug production quality management practice) on-site inspection of the dual-form pharmaceutical industry, and in July was informed of the passing of the inspection.At the same time, Shuangcheng Pharmaceuticals filed a PIV patent with the FDA in May (the patent related to the generic drug is invalid or generic drug is not infringed) and filed a patent challenge notice with the original drug's license holder and patent holder.Angiomax, developed by The Medicine Company, was approved by the FDA in the United States on December 15, 2000. At present, the original U.S. research products are still in the patent protection period, the patent period is until January 27, 2029.As the original research company received the notification within 45 days did not initiate any litigation against the company's injection of bivalding patent challenge, double-form pharmaceutical injection bivalding ANDA challenge patent success.So, Bival reeds in the United States approved water into the canal. On October 24, Shuangcheng Pharmaceuticals announced that it had received a notification from the FDA that the company's application to the FDA for a simplified new drug for injection was approved.In this regard, Shuangcheng Pharmaceuticals said that the company's injection of bivalding ANDA approved by the United States FDA, marking the company's production of injection of bivaldes in the safety and effectiveness of the international level. Through patent challenges, the company allowed the product to enter the U.S. market 10 years before the patent expired. The approval of this product is conducive to the opening up of overseas markets, for the follow-up in the United States to carry out generic drug production has laid an important foundation, the company's future operating results have a positive impact.

transfer or to turn aOriginally the use of Bival Luding to open up the international market is ready, shuangcheng Pharmaceuticals immediately put its rights for sale. Shenzhen Stock Exchange issued a letter of concern to this, asking the dual-form pharmaceutical industry to explain the production and sales since the "Drug GMP Certificate" obtained in May this year, the specific impact of the relevant technology transfer on the company's performance and the company's proposed response measures.At the same time, Shenzhen Stock Exchange requires Shuangcheng Pharmaceuticals to explain the specific evaluation method of the proprietary technical evaluation value of 45.14 million yuan involved in this transaction, the rationality of the selection of evaluation parameters, the reasons for the increase in value and the rationality; And analyze and explain the specific basis and fairness of the pricing of this transaction.Bivalding was once seen as the key to turning around the troubles of the dual-form pharmaceutical industry. Shuangcheng Pharmaceuticals is mainly engaged in the production, sale and research and development of chemical synthetic peptide drugs, leading products for thymus new raw materials and preparations. Shuangcheng Pharmaceuticals has revealed that the company's new thymus products in 2015 market share of 18.12%, annual sales in the domestic market ranked third. At the same time, however, the risk of a single main product persists. In 2018, thymus new preparation revenue accounted for 30.77 percent of the company's total operating income, more concentrated.Due to intensified competition in the main product market, the company's new product launch lag, coupled with investment failure, Shuangcheng Pharmaceuticals in recent years performance is in trouble. From 2016 to 2018, Shuangcheng Pharmaceuticals' net profit has been lost for three consecutive years, at -392.4823 million yuan, -47.0256 million yuan and -80.7336 million yuan, respectively.In this regard, Shuangcheng Pharmaceuticals explained that in 2016, the company's acquisition of Hangzhou Australia Biotech Co., Ltd. ("Hangzhou Australia") long-term equity investment collective impairment preparation, write-off of research and development projects, termination of the implementation of equity incentive programs, resulting in a significant loss of the company that year. In 2017, the company's main products competition increased, market sales without significant growth in the case of a substantial increase in investment, high costs, resulting in the company's main business continued to lose money. In 2018, in addition to the main product performance continued to be depressed, the holding subsidiary Ningbo Shuangcheng construction project into fixed assets, current depreciation, labor, interest expense and other related operating expenses increased significantly, resulting in a further decline in operating profit in 2018.In its response to the 2018 annual inquiry, Shuangcheng Pharmaceuticals said that in order to cope with the company's continued losses, the company will accelerate the injection of thymus and injection of the two main varieties of consistent evaluation of the two main varieties, if through the consistent evaluation, will greatly enhance the company's product competitiveness, is conducive to expanding market share, is conducive to the company's main business to bring significant improvement.In 2018, the new operating income of the thymus method of the dual pharmaceutical industry decreased by 27.3308 million yuan compared to 2017, and the operating income of peptide products decreased by 17% year-on-year.As of the end of the third quarter of this year, the performance of the dual pharmaceutical industry has not improved significantly. In the first three quarters, the Company achieved operating income of RMB270 million, up 4.15% YoY, and net profit loss attributable to shareholders of listed companies was RMB21.6338 million, while non-net profit loss continued to expand to RMB47.1731 million.Main product performance did not see a turnaround, but the new product rights to sell, Shuangcheng Pharmaceuticals this move by the market speculation or to reverse the deduction of net profit for three consecutive years of loss situation.The failure ofturning point in the performance of the dual-form pharmaceutical industry came in 2015.In January 2015, Shuangcheng Pharmaceuticals announced that it intends to acquire a 46% stake in Hangzhou Australia and Asia and a 100% stake in Hangzhou Oppeng Investment Management Co., Ltd. ("Openg Investment") for 1,467 million yuan. Upon completion of the acquisition, Shuangcheng Pharmaceuticals will directly hold a 46% stake in Hangzhou Australia and Asia, and indirectly hold a 54% stake in Hangzhou Australia and Asia through Oppeng Investment.At that time, Hangzhou Australia is the country's largest freeze-dried powder needle processing outsourcing enterprises. The acquisition set a performance commitment, Hangzhou Australia asia 2015-2017 net profit of not less than 110 million yuan, 120 million yuan and 130 million yuan, respectively, a total of not less than 360 million yuan.But after the deal was completed, Hangzhou Australia's performance was less than expected. According to Shuangcheng Pharmaceuticals' annual report, the net profit of Hangzhou Australia in 2015 was only 51.7343 million yuan, less than half of the promised performance. In 2016, the valuation of Hangzhou Australia and Asia plummeted from 1.47 billion yuan to 450 million yuan due to continued underperforming results. To this end, Shuangcheng Pharmaceuticals to Hangzhou Australia and Asia long-term equity investment impairment preparation of 277 million yuan, write-off of two research and development projects into the current profit and loss of 45.4305 million yuan, the termination of the implementation of the equity incentive program and accelerated the amortization of 13.933 million yuan of equity incentive fees in the current year, resulting in a substantial loss of the company in 2016.The acquisition of the stake in Hangzhou Australia also ended that year. In view of the short-term uncertainty about the operating conditions in Hangzhou, Shuangcheng Pharmaceuticals completed only a 46% equity acquisition of Hangzhou Australia and Asia, and terminated the equity acquisition of Openg Investment. However, Shuangcheng Pharmaceuticals said at the time that its target for the acquisition of Hangzhou Australia remained unchanged and that it was seeking to complete the acquisition by the end of 2018, with the terms of the deal to be negotiated separately.However, the plan changed two years later, Shuangcheng Pharmaceuticals not only failed to continue to buy Hangzhou Australia, but also the previous investment has been hastly closed. At the end of 2017, Shuangcheng Pharmaceuticals announced that it had transferred its 46% stake in Hangzhou Australia Biotech Co., Ltd. to Openg Investment for 260 million yuan due to strategic adjustments and due to deep-thy-gun business considerations, and that the company had fully recovered all of its funds by the end of 2018. (Minenet)