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According to the recent announcements of major pharmaceutical companies, NMPA and other information, at least 11 drugs were approved for listing in China in March, involving CStone Pharmaceuticals, Hansoh Pharmaceuticals, Junshi Bio, Eli Lilly, Novo Nordisk and other companies
.
Recently, the State Food and Drug Administration approved the application for registration of infliximab for injection (trade name: Jiayoujian®) filed by Yuxi Jiahe, with indications for rheumatoid arthritis, ankylosing spondylitis, psoriasis, and adult ulcerative colon.
inflammation, Crohn's disease, fistulizing Crohn's disease in adults and children over 6 years of age
.
After the drug is launched, it will bring more treatment options to patients
.
On March 14, CStone announced that the expanded indication of the RET inhibitor Pratinib (trade name: Pujihua) was successfully approved for marketing, and the product became the first approved product in China for RET mutant medullary thyroid cancer.
and selective RET inhibitors for RET fusion-positive thyroid cancer
.
Since the beginning of this year, in addition to Pratinib, CStone Pharmaceuticals has previously approved Avonib (trade name: Tuoshuwo)
.
On March 14, Nuocheng Jianhua announced that its Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib is a new indication for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia (WM).
The marketing application (sNDA) has been accepted by the State Food and Drug Administration
.
Previously, the product has been approved in China for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL) for two indications
.
On March 11, NMPA information was announced, and a number of pharmaceutical companies were approved for listing
.
Among them, inelizumab injection introduced by Hansoh Pharmaceuticals has been approved for marketing.
The drug was developed by Viela Bio for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD)
.
The inhaled nitric oxide of Zhaoke Pharmaceutical, a subsidiary of Li's Pharmaceutical Factory, was approved for marketing
.
According to the CDE priority review announcement, the product is approved for the following indications: combined ventilatory support and other appropriate drugs for the treatment of neonatal hypoxic respiratory failure (HRF) with clinical or echocardiographic evidence of pulmonary arteries Hypertension, which improves oxygenation and reduces the need for extracorporeal membrane oxygenation
.
Imalizumab, submitted by Supi Pharma, was also approved for marketing for the treatment of primary hemophagocytic lymphohistiocytosis in patients with refractory, relapsed or progressive disease or intolerant to conventional HLH therapy ( HLH) adult and pediatric (neonatal and older) patients
.
On March 6, Eli Lilly announced the official launch of its CDK4/6 inhibitor Weize® (Abecili Tablets) for early breast cancer indications in China
.
The drug was previously approved for use in combination with endocrine therapy (tamoxifen or aromatase inhibitor) for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node positive, high risk of recurrence Adjuvant therapy for adult patients with early breast cancer with Ki-67≥20%
.
On March 5, Novo Nordisk announced that the world's first basal insulin GLP-1RA injection Novoyi® (insulin degludec liraglutide injection) was officially launched in China
.
The drug is suitable for adults with type 2 diabetes mellitus (T2DM) with poor blood sugar control.
It can be combined with other oral hypoglycemic drugs on the basis of diet and exercise to improve blood sugar control
.
On March 4, Maiwei Bio and Junshi Bio jointly announced that the adalimumab injection (trade name: Junmaikang) jointly developed by the two parties was officially approved for marketing
.
It is reported that the drug is used for the treatment of rheumatoid arthritis, ankylosis spondylitis and psoriasis, and has won the support of the "Twelfth Five-Year Plan" national "Major New Drug Creation" science and technology major project
.
On March 2, Baiyunshan announced that its subsidiary Baiyunshan Pharmaceuticals developed tenofophate fumarate.
Verdipirate tablets were approved for the treatment of chronic hepatitis
B.
On March 1, Henlius announced that the company's first monoclonal antibody drug, Rituximab Injection (Hanlikang), was approved for new indications.
approved, in combination with methotrexate, for adults with moderately to severely active rheumatoid arthritis who have not responded to one or more TNF-α inhibitors
.
opinions, and do not constitute investment advice to anyone
.
.
Recently, the State Food and Drug Administration approved the application for registration of infliximab for injection (trade name: Jiayoujian®) filed by Yuxi Jiahe, with indications for rheumatoid arthritis, ankylosing spondylitis, psoriasis, and adult ulcerative colon.
inflammation, Crohn's disease, fistulizing Crohn's disease in adults and children over 6 years of age
.
After the drug is launched, it will bring more treatment options to patients
.
On March 14, CStone announced that the expanded indication of the RET inhibitor Pratinib (trade name: Pujihua) was successfully approved for marketing, and the product became the first approved product in China for RET mutant medullary thyroid cancer.
and selective RET inhibitors for RET fusion-positive thyroid cancer
.
Since the beginning of this year, in addition to Pratinib, CStone Pharmaceuticals has previously approved Avonib (trade name: Tuoshuwo)
.
On March 14, Nuocheng Jianhua announced that its Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib is a new indication for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia (WM).
The marketing application (sNDA) has been accepted by the State Food and Drug Administration
.
Previously, the product has been approved in China for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL) for two indications
.
On March 11, NMPA information was announced, and a number of pharmaceutical companies were approved for listing
.
Among them, inelizumab injection introduced by Hansoh Pharmaceuticals has been approved for marketing.
The drug was developed by Viela Bio for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD)
.
The inhaled nitric oxide of Zhaoke Pharmaceutical, a subsidiary of Li's Pharmaceutical Factory, was approved for marketing
.
According to the CDE priority review announcement, the product is approved for the following indications: combined ventilatory support and other appropriate drugs for the treatment of neonatal hypoxic respiratory failure (HRF) with clinical or echocardiographic evidence of pulmonary arteries Hypertension, which improves oxygenation and reduces the need for extracorporeal membrane oxygenation
.
Imalizumab, submitted by Supi Pharma, was also approved for marketing for the treatment of primary hemophagocytic lymphohistiocytosis in patients with refractory, relapsed or progressive disease or intolerant to conventional HLH therapy ( HLH) adult and pediatric (neonatal and older) patients
.
On March 6, Eli Lilly announced the official launch of its CDK4/6 inhibitor Weize® (Abecili Tablets) for early breast cancer indications in China
.
The drug was previously approved for use in combination with endocrine therapy (tamoxifen or aromatase inhibitor) for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node positive, high risk of recurrence Adjuvant therapy for adult patients with early breast cancer with Ki-67≥20%
.
On March 5, Novo Nordisk announced that the world's first basal insulin GLP-1RA injection Novoyi® (insulin degludec liraglutide injection) was officially launched in China
.
The drug is suitable for adults with type 2 diabetes mellitus (T2DM) with poor blood sugar control.
It can be combined with other oral hypoglycemic drugs on the basis of diet and exercise to improve blood sugar control
.
On March 4, Maiwei Bio and Junshi Bio jointly announced that the adalimumab injection (trade name: Junmaikang) jointly developed by the two parties was officially approved for marketing
.
It is reported that the drug is used for the treatment of rheumatoid arthritis, ankylosis spondylitis and psoriasis, and has won the support of the "Twelfth Five-Year Plan" national "Major New Drug Creation" science and technology major project
.
On March 2, Baiyunshan announced that its subsidiary Baiyunshan Pharmaceuticals developed tenofophate fumarate.
Verdipirate tablets were approved for the treatment of chronic hepatitis
B.
On March 1, Henlius announced that the company's first monoclonal antibody drug, Rituximab Injection (Hanlikang), was approved for new indications.
approved, in combination with methotrexate, for adults with moderately to severely active rheumatoid arthritis who have not responded to one or more TNF-α inhibitors
.
opinions, and do not constitute investment advice to anyone
.
