Research and development proportion forced Hengrui! Osaikang 7 first imitation amazing debut, 2 new drugs unveiled the veil.

On September 8, Osaikang approved another new drug clinically, and the company's 2 new drugs were injected with Grebenzene for acute CNS injury (acute spinal cord injury, acute brain trauma, ischemic stroke).
In recent years, Osaikang has continued to increase its innovation in research and development, with research and development spending as a percentage of sales revenue rising to 13.32% in the first half of 2020, no less than domestic research and development strength of head pharmaceutical companies such as Hengrui (16%), Fosun (12%), China Biopharmaceuticals (12%) and Stone Pharmaceuticals (12%).
according to Osaikang semi-annual report, the first half of 2020 two new drugs have been approved clinically, before the end of the year a number of first imitation is expected to be listed, the company is about to transition from "imitation combination" to "imitation combination."
anti-peptic ulcer leader, five PPI injections to support 70% performance With the growing socio-economic development, people work nervously, easy fatigue, diet is not regular, gastrointestinal stimulation caused by peptic ulcers gradually become a common disease.
meters of intranet data show that in 2019 in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal chemical treatment peptic ulcer drug market size has exceeded 40 billion yuan.
figure 1: Treatment of peptic ulcer drug TOP2 enterprise market share Source: Minet China's public medical institutions terminal competition pattern From the competitive situation of enterprises, in recent years, the market share of more than 10% only Osaikang and AstraZene, the third Shandong Luoxin Pharmaceutical Group only about 5%.
Osaikang's strengths are concentrated in injections, while AstraZeneta's focus on injections and internal medicines is more average, but in the face of the ongoing impact of generic drugs in China, the overall market share remains at only about 10%.
Table 1: Specific Situation of China's Public Medical Institutions Terminal Osaikang Five PPI Injections in 2019 Source: Minet China Public Medical Institutions Terminal Competition Pattern Osaikang's PPI (Proton Pump Inhibitor) Product Group Covers Five of the Six Listed PPI Injections in China (Ai Prasium for the Lizhu Group's class 1 new drugs), are the first or first domestic market in the same period, the five products together contributed nearly 75% of the company's performance, and the company's injection of omeprazole sodium, injection of lansoelazole, injection of reberazole sodium are in the market leading position.
Injection Consistency Evaluation "Declaration Pioneer", 10 products competed for the first evaluation on May 14, 2020, the State Drug Administration issued "on the implementation of chemical injection generic drug quality and efficacy consistency evaluation of the announcement", officially launched injection consistency evaluation, accelerate the phase-out of low- and medium-end injection varieties, accelerate the evaluation of generic drug consistency.
meters of intranet data show that as of September 11, 2020, a total of 178 injection declaration consistency evaluation, only 2 products were successfully approved, including Sichuan Huiyu Pharmaceutical injection with Pometraxel ii sodium and Hainan Puli Pharmaceutical's injection of azithromycin (approved according to the new classification of the same evaluation is not included in the statistics). table
2: Osaikang in the review of injection consistency evaluation supplementary applications Source: MED2.0 China Drug Review Database Osaikang's large multi-pound products concentrated in injections, in the implementation of injection consistency evaluation work also spared no effort.
Up to now, Osaikang has 13 injection product declaration consistency evaluation, of which 5 products for the first declaration (injection with right Rezosan is currently only Osaikang declaration), with the advantage of time, the first evaluation is more likely.
Research and development investment is rising steadily, the first half of the two new drugs approved clinical Figure 2: In recent years, Osaikang's research and development investment (units: 100 million yuan) Source: The company's annual report in recent years, Osaikang adhere to strengthen the capacity-building of research and development innovation, innovation capacity steadily improved, in the first half of 2020 research and development investment of 220 million yuan, an increase of 51.71 percent year-on-year, accounting for 13.32 percent of sales revenue.
Table 3:2020 to date approved clinical new drug situation Source: MED2.0 China Drug Review Database July 9, 2020, Osaikang issued a notice that received the State Drug Administration issued ASKB589 injection "Drug Clinical Trial Approval Notice", the product registration classified as therapeutic biological products 1 category.
it is known that ASKB589 injection is mainly through ADC and CDC anti-tumor cells, intended for use in the stomach and gastroesophageal binding adenocarcinoma, pancreatic cancer and other adaptive disorders.
results show that ASKB589 injection and target combination is highly specific, and the combination with chemotherapy drugs to treat stomach and gastroesophageal adenocarcinoma, pancreatic cancer and other malignant solid tumors have good prospects for development.
On September 8, 2020, Osaikang announced that it had received a "Notice of Approval for Clinical Trials of Drugs" issued by the State Drug Administration for injection of Grebenzene, which was jointly declared by Osaikang and the Military Medical Research Institute of the Chinese Civil Liberation Army Academy of Military Sciences, and was registered as a chemical class 2.2 and 2.4.
Injection grebenzene is mainly used to treat acute CNS injury (acute spinal cord injury, acute brain trauma, ischemic stroke), post-traumatic nerve cell edema caused by patients' vital signs deterioration, neurofunctic deficiency, is one of the current medical problems, in this field is still lack of effective treatment drugs, there is a great clinical need, market potential.
addition, the latest developments have been made in ASK120067, a new class 1 drug approved for clinical practice in 2017, which is a third-generation EGFR inhibitor targeted at T790M for the treatment of non-small cell lung cancer. In 2019, it won the national 13th Five-Year Plan "major new drug creation" science and technology major special project, and obtained CDE approval, after the completion of clinical II. Phase II research can be conditional approval for listing, the current first-line drug Phase III. clinical research is also being carried out in the same period.
with the gradual easing of the epidemic nationwide, clinical research has returned to normal, is expected to complete phase II clinical entry by the end of the year, in 2021 to apply for listing of CDE.
introduced the innovative drug maltophenol iron capsules, which have been listed in Europe and the United States through an exclusive patent license, developed by Shield Therapeutics Plc. of the United Kingdom and approved by the EMA and FDA in 2016 and 2019 for the treatment of adult iron deficiency (with or without anemia symptoms), and the company has now completed the preparation of registration materials and plans to file a registration application in the second half of 2020.
's 7th big imitation amazing attack! 3 tables expected to be on the market in 2020 4: 2018 to date approved for the market of products Source: Minet MED2.0 China Drug Review Database 2019, Osaikang won AstraZeneta's heavy diabetes drug shagritin tablets, and as a review, marking the company not only expanded the new dosage form, but also into the field of new chronic disease treatment.
Shagritin tablets are the category B varieties of the national health insurance catalogue, and sales began to explode after they first entered the country in 2017, with terminal sales of more than 500 million yuan in China's public medical institutions in 2019.
announcement mentioned that Osaikang's Shagritin tablets after 7 years of research and development, a cumulative investment of 16 million yuan, the current product has been linked to the network covering 27 provinces, borrowing two disease drugs (hypertension, diabetes outpatient drug reimbursement policy) and support the evaluation of drugs to replace the original research drugs and other policies, will achieve rapid sales growth.
Table 5: Applications for generic drugs listed under review from 2018 To date Source: MED2.0 China Drug Review Database Minet data show that the generic drug listing applications reviewed so far in 2018 involve eight products, six of which are expected to impact the first generic.
Novart's Aiqupopa and Tiraros 2019 global sales of $1.4 billion, 900 million U.S. dollars, respectively, currently only the original research imports, Osaikang's main competitors are Zhengda Tianqing Pharmaceutical Group, Beijing Kangchen Pharmaceuticals.
In addition, Posaconazole injection, injection with right-hand rebella sodium are the first domestic production, is expected to be the first to be listed in 2020;
In addition, in December 2019, Osaikang signed a letter of intent to cooperate with Shanghai Xuantai Pharmaceutical Technology, which will own the Posacon intestinal solution tablets in Chinese mainland (i.e., except in the Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan) exclusive promotion, commercial and agent sales rights and interests authorized Jiangsu Osaikang.
At present, only Merca East has been approved for import, Shanghai Xuantai's product category 4 imitation listing application is being reviewed and approved, is expected to win the first imitation, become another heavy product of Osaikang to improve performance.
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