NMPA (National Medical Products Administration).
Listing Approval:
1. On August 1, according to the official website of CDE, Astellas' Class 1 therapeutic biologics zotuximab for injection was applied for marketing for the first-line treatment of patients with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. This is the world's first CLDN18.2 monoclonal antibody.
2. On August 1, according to the official website of CDE, Ivonescimab Injection (code: AK112), a Class 1 therapeutic biological product of Akeso, was declared for marketing for the treatment of EGFR-TKI-resistant non-small cell lung cancer (NSCLC). AK112 is the world's first PD-1/VEGF bispecific antibody independently developed by Akeso to enter clinical studies.
3. On August 1, according to the official website of CDE, Jacobio's Grerese(JAB-21822) is intended to be included in a breakthrough therapy for the treatment of adult patients with locally advanced or metastatic pancreatic cancer with KRASG12C mutations who have disease progression after prior treatment with gemcitabine plus nab-paclitaxel or FOLFIRINOX. JAB-21822 is a KRASG12C inhibitor independently developed by Jacobio.
4. On August 2, according to the official website of CDE, the new indication of FibroGen Class 1 chemical drug Roxadustat Capsules was declared for marketing, and it was speculated that the indication was anemia caused by chemotherapy. Roxadusta is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by Fabojin, which is the first HIF-PH inhibitor in the field of CKD anemia.
5. On August 2, according to the official website of CDE, HEC Class 1 chemical drug Antaitavir phosphate capsules were declared for marketing for the treatment of chronic hepatitis C in adults. Antaitavir Hasophate is a hepatitis C virus (HCV) NS5A inhibitor that is structurally similar to Gilead's second-generation pan-genotype NS5A inhibitor vepatasvir (epclusa, Kyrgyzstan III).
6. On August 2, according to the official website of CDE, Nanjing ChiaTai Tianqing's Class 4 chemical drug palbociclib tablets were declared for marketing for the treatment of breast cancer. Chia Tai Tianqing became the third pharmaceutical company to apply for generic drugs of palbociclib tablets after Qilu Pharmaceutical and CSPC Pharmaceutical Group. Palbociclib is a small molecule CDK4/6 inhibitor developed by Pfizer.
7. On August 3, according to the official website of the NMPA, Qilu Pharmaceutical's Class 4 chemical drug fulvestrant injection was approved for marketing for the treatment of breast cancer. Fulvestrant is an estrogen receptor down-regulating agent (SERD) anti-breast cancer treatment drug, originally developed by AstraZeneca and approved for marketing in China in 2010.
8. On August 3, the official website of the NMPA announced that the new indication of Pfizer's 5.1 class chemical drug cliborol ointment (trade name: sultanmine) was approved, which is speculated to be used in children and adults aged 3 months and above with atopic dermatitis. Cleborol is a small-molecule, non-hormonal, non-steroidal anti-inflammatory topical phosphodiesterase 4 (PDE-4) inhibitor developed by Anacor.
9. On August 3, according to the official website of NMPA, Qilu Pharmaceutical's Class 4 chemical drug octreotide acetate microspheres for injection were approved for marketing for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, becoming the first generic version of octreotide acetate microspheres approved for marketing in China. The drug is a long-acting injection of the somatostatin analogue octreotide, which was originally developed by Novartis and only needs to be administered once a month, and the original drug entered China in 2003.
10. On August 3, according to the official website of the NMPA, BioNova Pharma’s Class 5.1 chemical drug besudil mesylate tablets, was approved for marketing for the treatment of graft-versus-host disease, becoming the first ROCK2 inhibitor approved for marketing in China. In November 2019, BrightAceuticals entered into an agreement with Kadmon, Inc. (acquired by Sanofi)...
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