Hundreds of billions of new drugs hit the market, Howson was approved, Qilu, green leaf sprint! Stone medicine attacks the lipid body, the oral dissolved membrane into a large heat

NMPA official website data show that Qilu, green leaves in the near future will be chemical drugs 2.2 new drugs approved for market, both new drugs are focused on the nervous system field, 100 billion market is expected to usher in a new change.
CDE issued the Technical Guidelines for Clinical Trials of Chemical Improved New Drugs in December 2020 to encourage the clinical development of new drugs in China, which has low research and development costs and high success rate compared to innovative drugs.
of which class 2.2 is an important development direction in China, so far, 21 new drugs are under review and are expected to be approved after 2021.
hundreds of billions of new drugs have emerged in the market, Howson, Qilu, green leaves have emerged chemical drugs 2.2 new drugs refers to the new dosage forms containing known active ingredients (including new drug systems), new prescription processes, new drug routes, and has obvious clinical advantages of the preparation.
In November 2020, Howson's O nitrogen flat-mouthed membrane was approved for the market, becoming the only new class 2.2 drug approved that year, which is an atypical antipsychotic drug for the treatment of mania in schizophrenia and bipolar disorder.
table 1: 2020 approved for the market of chemical drugs 2.2 new drugs source: Minet MED2.0 China Drug Review Database Minenet 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 nervous system drugs market size has exceeded 100 billion yuan, O nitrogen Ping for the market TOP4 varieties, sales of more than 4 billion yuan.
From the dosage form, the current variety is dominated by ordinary tablets, and has been included in the first batch of national mining, oral collapse tablets in the third batch of national mining was included, is expected to be released in 2021, oral dissolution film for the variety approved in the domestic new dosage form.
market landscape, Howson to occupy the top spot in the first half of 2020 with a share of 48.30%, the approval of new dosage forms is expected to enhance the company's market leadership position.
Table 2: Recently approved chemical drugs 2.2 new drugs Source: MED2.0 China Drug Review Database Qilu's O nitrogen flat tablets, O nitrogen flat-mouth collapse tablets approved by new classification and As reviewed, in the first batch of National Mining (alliance), the third batch of successful bid after the rapid entry into the hospital terminal, in the first half of 2020 Qilu in the variety market share has been increased to 10.23%, becoming the second domestic brand.
less than two months after the start of the year, Qilu's Ao nitrogen flat-mouthed membrane is about to be approved, and the new drug is expected to become Qilu's first approved chemical drug class 2.2 new drugs.
Lipe ketone is also China's public medical institutions terminal more than 1 billion varieties, the main dosage forms have tablets (dispersion tablets, ordinary tablets, mouth collapse tablets) accounted for 80%, solutions accounted for 13%, capsules and injections accounted for about 1% respectively.
injections for Xi'an Yangsen's injection of lipe ketone microbes, sales peaked at about 13 million yuan.
Shandong Green Leaf Pharmaceutical's injection of lipe ketone reissue microboules for the treatment of schizophrenia every two weeks injection of slow release microboules muscle injection preparation, can improve oral antipsychotic drugs in patients with schizophrenia common drug compliance, and will simplify the course of treatment of schizophrenia, the new drug approved after the market will be a positive impact on the original research products.
21 new drugs under review: Qilu holding 4 large mouth soluble film, stone medicine re-attack lipid body table 3: in the review and approval of chemical drugs 2.2 new drug situation source: Minenet MED2.0 China drug review database Minenet data show that the current review and approval of chemical drugs 2.2 new drugs have 21 (by product name and enterprise statistics).
Among them, Qilu has four oral dissolved membranes distributed in respiratory medicine, nervous system drugs and reproductive urinary system and sex hormone drugs;
Monrust is a respiratory drug nearly 3 billion varieties, ordinary tablets, chewing tablets, granules have been included in the national collection, Mercadon in the first batch (alliance) bid ordinary tablets failed to stop the impact of domestic generic drugs, market share in the first half of 2020 fell to 49.02%.
Monrust sodium mouth solution membrane only Qilu declared the listing and is in trial.
Alipide is a neurological drug more than 1 billion varieties, the current market approved dosage forms have tablets (including mouth collapse tablets), capsules and solutions, no products have been included in the national collection.
market leader is Chengdu Kanghong Pharmaceutical Group, with a market share of 47.59% in the first half of 2020.
altruo oral solution film only Qilu declared the listing and is in trial.
Mei Jingang, Tadalafi are nervous system drugs, reproductive urinary system and sex hormone drugs in the super-billion-dollar varieties, declared oral dissolved membrane on the market and in the trial of only Qilu.
if Qilu took all these new drugs, it will become a leading pharmaceutical company of oral dissolved membrane.
lipid body is a new type of preparation in recent years in the field of pharmaceutical research is very active, is formed by lipid double molecular layer particle size at the nano-level vesicles, can be toxic side effects, poor stability in the blood, rapid degradation of drugs wrapped in lipid body, carrying drugs in the lesions, to achieve the purpose of targeted administration, thereby improving efficacy, reduce toxicity, enhance stability.
meters of internal network data show that the current domestic market lipid drugs have hydrochloric acid polyflexes than astrolipid body injections, injections of b lipids of bisphenycin and injections of yew alcohol lipids. table
: Current sources of lipid drugs in the domestic market: Minenet MID drug index integrated database injections of yew alcohol lipids and hydrochloric acid dorobi star liposome injections are anti-tumor and immunomodulants of 3 billion levels of large varieties.
Injection with Yew alcohol lipids as the exclusive product of green leaves, in 2018-2019 in China's public medical institutions end-sales growth rate of more than 10%, while hydrochloric acid polyphosphate injections are currently led by the stone drug Omega Pharmaceuticals market, the first half of 2020 market share of 59%, and the brand's sales growth in the last three years are more than 20%.
Stone Pharmaceutical Group said that the hydrochloric acid mitoxine lipid body injection is the world's first mitoxyquinone lipid system agent, the new drug market application is mainly based on a recurrence / difficult treatment of external T cells and NK / T cell lymphoma in the single arm, open, multi-center Phase II study results.
Stone drug in the liposome drug research and development road forward, currently in addition to the chemical drug 2.2 classes of new drug mitothoquinium lipid body injection application in the review and approval, Ilithikang lipid body injection of the chemical drug class 2.4 new drug clinical application was approved, injection of two-sex mycomycin B lipid body chemical class 3 generic clinical also approved.
improved new drugs three-year revenue of more than 400 million, the pharmaceutical company to be listed in the review and approval of 21 chemical drugs 2.2 classes of new drugs, Hunan Warner Pharmaceuticals accounted for 3, respectively, zoonazole dispersion tablets, zoonazine capsules and Entekavir particles, are whole-body anti-infective drugs.
Zoonitazine currently has two dosage forms of tablets and injections on the market: injections account for more than 90% of the exclusive products of Nanjing Sanhe Pharmaceuticals, while ordinary tablets by Hunan Warner Pharmaceuticals and Nanjing Sanhe Pharmaceuticals to win the approval, competition is relatively moderate.
Entekawe 2018 in China's public medical institutions terminal sales of more than 8 billion yuan, tablets (including dispersive tablets) and capsules have been included in the national collection, in November 2020 Yangzijiang's Entekave oral solution 3 imitations were approved for listing and as reviewed, the current particulate agent only Hunan Warner Pharmaceutical Factory declared and reviewed.
Figure 1: Hunan Warner Pharmaceutical Factory Meeting Source: Oriental Fortune Network june 2020, Hunan Warner Big Pharmaceutical Company declared the listing of the board, the same year on December 15, the initial publicity was approved.
prospect <2>, the company's main business income of generic drugs and modified new drug revenue accounted for a relatively high, 2017-2019, generic products sales revenue accounted for 44.08 percent of the main business income, 49.9 percent 61% and 55.04%, while the sales revenue of improved new drugs accounted for 29.75 percent, 27.45 percent and 22.40 percent of the main business revenue, respectively, and the total sales revenue of improved new drugs exceeded 400 million yuan in three years.
figure 2: Hunan Warner Pharmaceuticals modified new drug research and development pipeline source: prospectine prospects mentioned that polycool sodium particles and sodium serum serum particles are mainly for children's medicine field, polycool sodium particle adaptation is constipation, sodium particle adaptation is iron deficiency anemia, the total research and development budget of these two projects is close to 30 million yuan, the funds raised from the listing will also be used in part for the research and development of these two projects.
Hunan Warner Pharmaceutical Co., Ltd. said that in the future, the company will continue to enhance the chemical generic drugs, improved new drugs in the field of research and development, industrialization of the core competitiveness, to build a comparative advantage in the industry.
2021, China's improved new drugs will usher in a blowout period, the final which new drugs can "go down in history", we will wait and see.