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Medical network September 18, recently, the Shanghai Medical Insurance Bureau issued a message, will be Fuhong Hanyu Quzhu single anti-injection into the city's medical insurance, the insured person's personal fixed out-of-payment standard of 670 yuan / bottle (150mg).
On August 14th, Fuhong Hanxuan announced that its own research and development of the curto-pearl single anti-Hanquyu (HLX02, EU commodity name: Zercepac) was approved by the State Drug Administration, and on July 27th, the drug was approved by the European Commission for listing on the European market, thus becoming the first chinese-EUROPEAN dual-batch domestic single anti-bioscise drug.
, Han Quyou has obtained all the indications approved by the original research in China, including HER2-positive early breast cancer, HER2-positive metastatic breast cancer, HER2-positive metastatic stomach cancer.
It is understood that the curtojudan antigen research drug is developed by Roche a targeted HER2 humanized monoclonal antibody, which is currently unanimously recommended by the international medical community HER2-positive breast cancer and stomach cancer standard treatment drug, which was approved in the United States in 1998, the commodity named Hersatin (Hersatin) Herceptin, approved to enter the Chinese market in 2002, was included in the national health insurance list in 2017, the price per bottle from 24,500 yuan to 7,600 yuan, and through continuous price reduction successfully renewed the 2019 health insurance, the latest payment price of 5,500 yuan per bottle.
In the industry, qutoju single resistance by many breast cancer patients called "life-saving drugs", before, some doctors also said that curtoju single resistance for some cancer patients is a necessary drug, for the surgery to reduce the recurrence rate is very effective, there is no alternative drugs in China for the time being.
As a result, Hessetin quickly became Roche's ace drug, with global sales of more than 5 billion Swiss francs ($5 billion) since 2010 and rising, with global sales of nearly $7 billion in 2018, making it Roche's "money printing machine", but with the advent of the patent period, Competition for generics and biosimilars has seen Hercetin's market share split among the world, with Roche's 2019 annual results report showing that Hercetin earned SFr6,039 million in 2019, down 14 percent from 2018 and the biggest decline in Roche's heavyweight product line during the year.
In response to the impact of Hercetin biosymporbants, Roche has introduced Perjeta (Pato Pearl Monoanti) and Kadcyla (Enmetroto Pearl Monoanti) in succession, in which Perjeta, although the same as the curtoju single resistance target, but the two are different from HER2 binding points, combined use can play a synergy to prevent the growth and survival of cancer cells.
Kadcyla, on the other hand, is an antibody-coupled drug that delivers DM1 to HER2-positive breast cancer cells via a stable link between Hercetin's active drug ingredient and ImmunoGen's cytotoxic agent DM1.
Kadcyla has 2 anti-cancer properties, her2 inhibitory effects of curvature monoantigen and cytotoxicity of DM1.
so far, Perjeta and Kadcyla have been approved for listing in China.
with the full layout of Perjeta and Kadcyla, Hessetine has had to face more competitors.
in foreign markets, in July last year, Amjin joined forces with Aer to launch Kanjinti in the U.S. market, and offered some sincerity in terms of price, with Kanjinti offered to the market at $3,697.26 per 420 mg multi-dose vial, 15 percent lower than Hercetin's price.
In December, Mylan teamed up with Biocon, an Indian drugmaker, to successfully launch Hercetin biosimilar Ogivri in the United States, which includes 420mg multi-dose vials and 150mg single-dose vials to provide patients with dose and treatment flexibility.
corresponding to the Chinese market, in November 2017, the Drug Review Center of the State Drug Administration issued "Clinical Research Design and Review Consideration Points for Injection-based QutoZhu Mono-Biosimilar Drugs" for public consultation, combined with the characteristics of the variety to refine the imitation strategy, to encourage more local Enterprises in China to actively develop biosimilar drugs.
Currently in China, Quto Zhudan anti-biosimilar drugs have been approved for listing in addition to Fuhong Hanyu's Hanquyou, there are Sansheng Guojian's Septin (Inito single resistance), at the same time, including The Shanghai Institute of Biological Products, Jiahe Biology, Zhengda Tianqing, Hualan Genetic Engineering, Haizheng Pharmaceuticals, Anke Bio and other domestic pharmaceutical companies have entered Phase III clinical, Wanle Pharmaceuticals, Qilu Pharmaceuticals and other clinical phase I.
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