East Sunshine Class 1 hepatitis C new drug is about to be approved! Henrui Eye's new drug is expected to be 10

This week look at point 1. International drug dynamics 2. East Sunshine Class 1 new hepatitis C drug "Phosphate Emitawe capsule" is about to be approved! 3. Hengrui two class 3 generic drugs declared listed 4. Pfizer heavy breast cancer new drug China declared new adaptive 5. More than one heavy biological agent was approved for import! This issue (December 4 to December 11) international and domestic review and approval of a number of products made new progress.
, the new crown inactivated vaccine of the Pharmaceutical Group of China was approved for sale in the United Arab Emirates, and the new crown vaccine of Pfizer/BioNTech was approved for sale in Canada.
FDA approved Novo Nordiella peptides for the treatment of obesity in 12-17-year-olds, and the FDA approved BioCryst oral innovation therapy Orladeyo to prevent the onset of hereditary angioedema.
the world's first treatment for Smith-Magillion syndrome, Hetlioz was approved by the FDA for listing after it was approved by the FDA to treat non-24-hour sleep-wake disorders in adults.
in China, the end of the year will be, CDE accelerated review and approval, a number of heavy-weight single resistance approved imports, generic drugs approved in large numbers, more dynamics are as follows: domestic review and approval, new dynamic this week CDE has 78 acceptance numbers (47 varieties) Report production status update, its Middle East Sunshine Phosphate Emitawe capsule, Koxing bio23 price pneumonia vaccine and a number of biological agents have attracted much attention, more dynamics are as follows: East Sunshine Class 1 new drug "Phosphate Emitawe Capsule" will soon be approved! Pharmaceutical data show that Dongsian's class 1 new drug "Phosphate Emitawe Capsule" NMPA processing status changed to "in approval", will soon be approved for listing.
is a Class 1 oral direct antiviral drug (DAA) developed by Dongsian, and is the first new Class 1 drug to be listed in Dongsian.
, which was listed on September 12, 2019, was included in the priority review and approval process in November of the same year as "innovative drugs with significant therapeutic advantages" and entered the administrative approval phase in December this year.
there are currently 9 antiviral class 1 new drugs in the study, focusing on hepatitis C, hepatitis B two major adaptive disorders.
with the approval of new drugs, Dongsong will not only break out in the generic drug market, but also expand the market for innovative drugs and consolidate its market position in the antiviral field.
23-price pneumonia vaccine was approved for listing in China on December 9, and the application for the development of 23-price pneumonia vaccine by Koxing Bio was approved.
the vaccine is intended for people 2 years and older with an increased risk of pneumococcal infection and is used to prevent infectious diseases caused by the 23 serotype pneumococcal species mentioned above.
23 pneumococcal polysaccharide vaccine is the first bacterial vaccine product approved by Koxing Bio, and is one of the few 23-price pneumococcal polysaccharide vaccines in the world with pre-filled syringes and xilin bottles.
Consensus of Experts on Immunization Against Pneumococcal Diseases (2020 edition) recommends that it is necessary and urgent to use pneumococcal vaccine to prevent pneumococcal diseases.
23-price pneumococcal polysaccharide vaccine can cover more than 85% of the disease-caused serotoning, is currently on the market one of the most widely protected pneumococcal vaccine.
Fuhong Hanyuan's third single anti-biological drug Handayuan® was approved for listing recently, Fuhong Han's Adamu single anti-biosychable drug (commodity name: Handayuan, HLX03) was approved for listing in China for the treatment of rheumatoid arthritis, strong straight spina bifida and psoriasis.
This product is the third single anti-biopharmaceutical successfully listed in China after the first Chinese-made biosynthic drug Hanlikang (Lytoxi single resistance), and the first Central European double batch of Chinese-made single-anti-bio-similar drug Hanquyou (Quto Zhu single-resistance, EU commodity name: Zercepac).
Adamo single resistance (Shumeile) is AbbVie developed the first anti-TNF-α single resistance, the original research product Shumeile since the first approval of the market in 2002, has been approved for treatment more than a dozen Different adaptive disorders, approved for import into China in February 2010, are currently approved in China for moderate to severe rheumatoid arthritis, moderate to severe severe spina bifiditis and moderate to severe chronic plaque psoriasis 3 adaptive disorders.
Handa is the fourth Adamo mono-biological-like drug approved for sale in China.
previously, similar products from Baiotai, Haizheng Pharmaceuticals and Xinda Bio had been approved for sale in 2019 and September 2020.
addition, Junshi Bio, Zhengda Tianqing and other companies of Adamo single anti-biosychic drugs have also submitted a listing application in China, is currently under review and approval.
several heavy-duty biologics were approved for import! Mercadon Paboli juju monotherapy was approved in China as the sixth adaptive disorder for first-line single-drug treatment in patients with squamous cell carcinoma (HNSCC) in the head and neck.
Previously, Paboliju monoantigen resistance had been approved in China for the treatment of melanoma; single-drug or combination chemotherapy first-line treatment with PD-L1 positive, local late stage or metastasis non-small cell lung cancer without EGFR or APK mutations; PD-L1 tumor ratio score (TPS) ≥1% of EGFR gene mutation-negative and APK-negative local late stage or metastatic non-small cell lung cancer first-line single-drug treatment;
GlaxoSmithKline (GSK) Bellevue mono-anti-new adhesive disease was approved in a joint with conventional treatment and is suitable for patients 5 years and older who still have high disease activity (e.g., antides-DNA antibody-positive and low complement, SELENA-SLEDAI score ≥8) on the basis of conventional treatment.
Bellevue is the world's first biological agent approved for the treatment of systemic lupus erythematosus, and its new adaptation has been approved in China, meaning it is also the first innovative treatment approved by the FDA and China's NMPA to treat children with lupus erythematosus.
Blinatumomab has been officially approved in China for the treatment of adult recurrence or refractic precursor B-cell acute lymphoblastic leukemia (ALL), and is the first dual-specific antibody drug approved in China for the treatment of ALL patients. the
-lyntomo dual-specific antibody, which can target both CD19 and CD3, is the first dual-specific T-cell joint (BiTE) immunotherapy approved by the FDA and has been recognized as a breakthrough therapy.
it is worth noting that the earlier cooperation agreement between Baiji Shenzhou and Anjin company includes that Baiji Shenzhou will commercialize Anjin approved tumor products in China, including Perintomo double resistance.
Domestic review and approval of the new acceptance of this week's CDE new report production acceptance number 29, a total of 20 varieties, of which Hengrui Pharmaceutical deoxynephrine ketamine acid solution, Obecholic acid tablets and Pfizer persili tablets are of great concern, more dynamics see the table below: Hengrui Pharmaceutical 2 3 categories Generic drug declaration listed Henriobic bile acid tablets listed application for CDE acceptance, adaptation may be: united bear deoxycholic acid for the treatment of bear deoxycholic acid (UDCA) response is not sufficient, or single drug used for UDCA insatiable primary bileitis (PBC).
, developed by Intercept Pharmaceuticals of the United States, was approved for listing by the U.S. FDA in May 2016 and the European Union in December 2016, becoming the first drug approved for PBC treatment in nearly 20 years.
the original drug was not listed in China, according to The New York Times, and two companies, including Hengrui, are currently listed, the other being Tianqing in Nanjing.
It's worth noting that the most market-promising adaptation of Obecholic acid is non-alcoholic fatty hepatitis (NASH), but in July this year the FDA rejected Intercept's application for the listing of Obecholic acid treatment for liver fibrosis caused by NASH, arguing that the benefits of the interim histological endpoint data remain uncertain and recommending that Intercept provide ongoing REGENERATE follow-up effectiveness and safety data to assess whether the benefit risk ratio has been achieved.
Hengrui deoxynephrine ketic acid solution listed application was accepted by CDE, for cataract surgery or artificial crystal replacement surgery to maintain the size of the pupil, prevent the pupil in surgery to shrink and relieve pain in the eyes after surgery.
deoxynephrine chromic acid solution is a compound eye solution consisting of deoxynephrine and ketone chromic acid.
the drug, first developed by Omeros, was approved by the FDA in May 2014 for listing under the name Omidria, and in July 2015 it was approved for listing by EMA in Europe.
Hengrui for the variety of the first domestic declared listed manufacturers.
Pfizer has filed a new drug for heavy breast cancer in China, two new drug listing applications for Pfizer's targeted cancer drug, palbociclib, were accepted by CDE.
is the world's first approved CDK4/6 inhibitor, which has been recognized by the FDA as a breakthrough therapy.
In China, the company was approved for the market in 2018 with the following adaptations: positive hormone-positive (HR-plus), human skin growth factor inhibitor 2 negative (HER2-) local late stage or metastatic breast cancer, as an initial endocrine treatment for post-menopautic female patients.
is also approved in the United States for endocrine therapy after the progression of the disease in female breast cancer patients, as well as advanced male breast cancer patients.
that global sales of the drug will reach $4,961 million in 2019.
addition to breast cancer, Pybersili is also exploring new adaptations in clinical studies.
, in combination with Roche's PI3K alpha inhibitors and estrogen therapy, it has shown encouraging results in phase 1/1b clinical trials in patients treating solid tumors with PIC3CA mutations.
data sources: pharmaceutical intelligence data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, enterprise announcements and other network public information