On January 18th, the medical network "10 years, 1 billion US dollars", the buzzword in the field of innovative medicine, shows the characteristics of long innovation, investment and high risk of innovative drugs. Recently, the reporter learned that the beneficiary countries have accelerated the progress of the examination and approval of innovative drugs, and pharmaceutical companies that have invested in new drug research and development for many years are expected to enter the harvest period in 2019. According to data from the Center for Drug Evaluation, at least 13 new chemical and biological drugs in the chemical category are currently awaiting approval by the Food and Drug Administration. Judging from the progress of the approval period, many products are expected to be approved before the end of 2019, including many listed companies such as Beida Pharmaceutical, Hengrui Medicine and Kanghong Pharmaceutical.
Driven by the reform of the national drug review and approval, the progress of approval of innovative drugs has obviously accelerated. The data show that between 2007 and 2017, only 10 independently developed chemical and biological drugs were approved in China. In 2018, 1.1 types of chemical and biological drugs developed by seven local companies were approved. According to the data of the Drug Evaluation Center, at least 13 new chemical and biological drugs are waiting for approval by the Food and Drug Administration, 197 are in Phase II and Phase III clinical trials, and 224 are in Phase I clinical trials.
Lin Na, a pharmaceutical industry analyst at UBS Securities, said that it usually takes 1 to 1.5 years from the receipt of the approval by the SFDA, but Class 1 chemicals and biopharmaceuticals may be approved at a faster rate within the next two years.
Which listed companies' innovative drugs are expected to be listed in 2019? The reporter found out that the chemical class 1 new drugs or biopharmaceuticals of three A-share companies, including Beida Pharmaceutical, Hengrui Medicine and Kanghong Pharmaceutical, are waiting for the listing approval. The products of China's innovative pharmaceutical companies listed on the Nasdaq Stock Exchange or the Hong Kong Stock Exchange, such as Baekje Shenzhou, Ding Ding Pharmaceutical, and Ge Li Pharmaceutical, will also enter the final sprint period.
In terms of varieties, oncology drugs are still the “fragrant†of innovative pharmaceutical companies, while biopharmaceuticals are mainly PD-1 monoclonal antibodies. Following Beida's first small molecule targeted anti-cancer drug ectinib (product name "Kemena"), the market has been asking "Who is the next Kemena". At the end of December 2018, with the application for the registration of the drug of nshatinib hydrochloride, Beida Pharmaceuticals gave the answer. It is reported that ensatinib HCl (X-396) is a new molecular entity compound developed by Beida Pharmaceutical and its holding subsidiary Xcovery Holdings, Inc., which has completely independent intellectual property rights. It is a new type of powerful, A highly selective new generation of ALK inhibitors. This product is used in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously been treated with crizotinib or who are intolerant to crizotinib-resistant anaplastic lymphoma kinase (ALK).
Hengrui Medicine, which has been deeply cultivated for many years in the field of oncology, has two new drugs nearing the market. Among them, the target of carrelixizumab for injection is PD-1, and the approved PD-1 product line will be further expanded. In 2018, Junshi Bio's PD-1 product, Treipril monoclonal antibody, was first introduced. In the eyes of the industry, PD-1 will be the most popular heavy product in 2019. As more PD-1 products are approved, the market competition will be more complete. Another class 1 chemical new drug of Hengrui Medicine is resorcinol toluenesulfonate for sedative injection. Although the field of psychiatric anesthesia is relatively conservative due to its safety and its scale is small, its advantages are reflected in the relatively long life cycle of the product, so it is favored by pharmaceutical companies.
In the field of diabetes, pharmaceutical companies are competing for another "treasure land." The reporter found that Kang Hong Pharmaceutical's biological products Compaq Xipu Ophthalmic Injection is also listed in the listing application. According to the relevant person in charge of the company, the company's declared Compaq Xipu has added diabetes indications, and the approval of the listing will further meet the market demand.
In addition, Ding Ding Pharmaceutical's Nilapali Toluene Capsule (Ovarian Cancer Drug), Baekje Shenzhou Resilizumab Injection (Lymphoma Drug), and Gyula Pharmaceutical's Ravidavir Tablets (CV) A variety of innovative drugs, such as medications, have also entered the sprint period, which deserves constant attention.
Guosen Securities pharmaceutical industry analysts pointed out that the approval of innovative drug varieties will gradually promote innovative pharmaceutical companies to accelerate the transition from research and development to harvest. It is reported that after the adjustment of the medical insurance catalogue in 2017, some heavy-duty varieties have joined the medical insurance, and some provinces and cities have not included the drug-related ratio assessment. In 2017, although the product price dropped more, the dosage increased rapidly. Taking into account access and other tender process after another modest lag in 2019 after the entry price decline of these species disappear factors, it is expected to get generic drugs, after adjuvant scale structural compression Medicare bonus.
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