Hengrui's 2 billion + blockbuster new drug hhpg-19k is about to go on the market!

On February 20, the registration status of Hengrui pharmaceutical's polyethylene glycol recombinant human granulocyte stimulating factor injection (hhpg-19k) changed to "under triad review", and it is expected to obtain the production approval document soon (refer to hhpg-19k, the next heavy ammunition of Hengrui pharmaceutical research and development) after completing the on-site inspection of the enterprise, the three reports of "technical evaluation report (Pharmacology, clinical, pharmacy), on-site inspection report, and product inspection report" will be summarized into a review opinion data and submitted to the registration department for approval Generally, the registration department will give approval opinions within a short time and submit them to the administrative service center for certification It should be noted that if the registration application of the enterprise fails to pass the technical review, CDE will not arrange for on-site verification In other words, on-site verification means that the registration application has passed the technical review During the three in one review process, it may involve the revision of the contents of the drug specification or the review of the drug name After completion, CDE will form a unified drug review report and submit it to the registration department for approval Brief introduction of granulocyte colony stimulating factor (G-CSF) tumor radiotherapy and chemotherapy usually kill normal cells by mistake or lead to bone marrow suppression, resulting in a significant reduction of white blood cells, increasing the risk of fever or infection in patients Granulocyte colony stimulating factor (G-CSF) is a kind of glycoprotein, which can combine with specific receptors on the surface of granulocyte progenitor cells or mature neutrophils, promote the proliferation and differentiation of granulocyte progenitor cells, and enhance the phagocytosis and killing ability of neutrophils G-CSF is not only used as adjuvant of tumor chemotherapy, but also used for mobilization of hematopoietic stem cells in bone marrow transplantation, reconstruction of hematopoietic function after transplantation, and improvement of neutropenia caused by myelodysplastic syndrome or myelodysplastic syndrome G-CSF, as the first chemoradiotherapy-related neutropenia drug in clinical guidelines at home and abroad, includes two types: short-term and long-term Long-term G-CSF is mainly prepared by polyethylene glycol modification Short acting G-CSF needs to be administered once or twice a day in each chemotherapy cycle, while PEGylated G-CSF usually only needs to be administered once in a chemotherapy cycle General situation of G-CSF drug market at home and abroad Amgen launched the world's first recombinant human granulocyte colony stimulating factor neupogen on February 20, 1991, which was widely accepted in clinical practice In recent 20 years, the sales volume of neupogen (1996-2015) has been stable at more than US $1 billion; on January 31, 2002, Amgen launched the world's first long-acting G-CSF drug neulasta, whose sales volume was close to that of short-acting G-CSF drug neupogen in the second year and became a heavy bomb, Moreover, the market share has been climbing all the way, and the global sales by 2015 has reached US $4.715 billion, and the sales of long-term G-CSF have been almost monopolized in the world The annual sales of neupogen and neulasta are shown in the figure below Other long-acting G-CSF drugs listed abroad also include Teva's lonquex (see the table below), which was approved by the European Union in August 2013 Since the first listing of G-CSF by kylin in China in 1993, nearly 20 domestic enterprises have produced short-term G-CSF drugs The long-acting G-CSF drugs that have been listed in China are only jinyouli of bacco biology and xinruibai of Qilu pharmaceutical Hhpg-19k of Hengrui is the fastest development progress in the research of long-acting G-CSF in China, which is only a step away from the market Long acting G-CSF listed in China short acting G-CSF listed in China part of G-CSF drugs under research in China data source: market prospect of medicine magic formula Hengrui hhpg-19k From the perspective of market pattern of domestic G-CSF drugs, In 2014, the sales of short-term G-CSF in the sample hospitals accounted for 98.3%, among which the short-term G-CSF product rebai of Qilu pharmaceutical accounted for more than 42% of the market share; at present, the long-term G-CSF on the market in China only has the jinyuli produced by Baike biology, but in 2014, the proportion of jinyuli in the total sales of the sample hospitals was only 1.7% (Note: the data refer to the Research Report of Guangfa Securities) From the development experience of foreign G-CSF drugs, long-acting G-CSF will become the mainstream of the market with significant treatment advantages, and the domestic G-CSF market is facing the opportunity of upgrading Neulasta, Amgen's long-term G-CSF product, is not registered in China Although jinyouli, a pioneer of petrochemicals, still has no sales scale Xinruibai of Qilu pharmaceutical has just been approved Therefore, Hengrui's 19-k has not lost the opportunity to compete for the market From the perspective of the market scale of domestic G-CSF drugs, the sales volume of domestic sample hospitals in 2014 was about 800 million yuan, and the total sales volume of G-CSF was estimated to be about 3.2 billion yuan by four times Assuming that long-term G-CSF can replace 50% of the current market share of short-term G-CSF, its market space is expected to reach 5 billion yuan (Note: data refer to the Research Report of Guojin securities) Considering the clinical data, the protection degree of Hengrui 19-k to neutropenia caused by chemotherapy of advanced small cell lung cancer can be more than 6 times, which is significantly superior to short-term G-CSF product and long-term G-CSF product of Baike biology, with considerable competitive advantage In particular, 19K obtained the new generic name of whos, which is not the generic drug of neulasta, but the new drug of long-acting G-CSF family In the future, it has the pricing power in the bidding and medical insurance negotiation Therefore, it is expected that 19K will occupy a large market share, and its sales volume is expected to reach 2 billion yuan in the future, becoming another 2 billion + pillar product of Hengrui after apatinib and regletin.