People’s Daily Health Client Liu Meiyan
Since March, my country has welcomed a number of new drugs to the market. According to incomplete statistics from the People’s Daily Health Client, at least 7 new drugs have been approved for marketing, and 8 drugs have been approved for new indications.
Drugs: Maidarone Dronedarone Hydrochloride Tablets
Manufacturer: Sanofi
Indication: Atrial fibrillation
On March 19, Sanofi China announced the launch of its antiarrhythmic drug Midarone Dronedarone Hydrochloride Tablets in China for the treatment of patients with paroxysmal or persistent atrial fibrillation (atrial fibrillation). patients with sinus rhythm with a history of atrial fibrillation, reduce the risk of hospitalization for atrial fibrillation.
Drugs: Duvelise Capsules
Manufacturer: CSPC
Indication: Relapsed or refractory follicular lymphoma
On March 18, the new anti-cancer drug Duvelise Capsules introduced by CSPC was approved in China for the treatment of patients with relapsed or refractory fibrosis who have undergone at least two systemic treatments in the past. Adult patients with vesicular lymphoma. This is a dual inhibitor of PI3K-delta and PI3K-gamma, and CSPC has the exclusive license to develop and commercialize this product in Greater China.
Drug: Ramucirumab
Manufacturer: Eli Lilly
Indication: Advanced gastric cancer
On March 18, Eli Lilly’s VEGFR-2 monoclonal antibody ramucirumab injection was approved for marketing in China for the second-line treatment of advanced gastric cancer. Treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma with disease progression during or after fluorouracil- or platinum-containing chemotherapy. This is also the first and only targeted drug approved for second-line treatment of advanced gastric cancer in China.
Drug: Inelizumab
Manufacturer: Hansen Pharmaceutical
Indication: Neuromyelitis optica spectrum disorders
On March 14, Inelizumab, an anti-CD19 antibody introduced by Hansoh Pharmaceuticals, was approved for marketing in China. In the United States, the drug is approved for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, serious autoimmune disease that attacks the optic nerve, spinal cord, and brain stem, causing blindness and paralysis.
Drug: Imalizumab
Manufacturer: Supi Pharmaceutical
Indication: Hemophagocytic lymphohistiocytosis
On March 11, Supi Medicine’s interferon gamma (IFNγ) antibody imalimumab injection was approved in China for indications: refractory, recurrent Treatment of adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with progressive disease or intolerant to conventional HLH therapy.
Medications: Nitric Oxide for Inhalation
Manufacturer: Lee’s Pharmaceutical
Indication: Neonatal hypoxic respiratory failure
On March 11, the vasodilator inhalation nitric oxide introduced by Lee’s Pharmaceutical Factory was approved for marketing in China, combined with ventilatory support and other appropriate drugs for the treatment of neonatal Hypoxic respiratory failure (HRF) with clinical or echocardiographic evidence of pulmonary hypertension, thereby improving oxygenation and reducing the need for extracorporeal membrane oxygenation (ECMO).
Drugs: Adalimumab Biosimilar
Manufacturing companies: Junshi Bio, Maiwei Bio
Indications: Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriasis
On March 3, the adalimumab biosimilar drug jointly developed by Junshi Bio and Maiwei Bio was approved for marketing in China for the treatment of rheumatoid arthritis and ankylosing spine inflammation and psoriasis. Adalimumab was originally developed by AbbVie. It is a TNF-α monoclonal antibody. It was first listed in the United States in 2002 and entered the Chinese market in 2010 under the trade name of “Humei Le”.
In addition, 8 drugs were approved for new indications in March:
Drugs: Ensatinib Hydrochloride Capsules
Manufacturer: Betta Pharmaceuticals
New indication: non-small cell lung cancer
Betta Pharma’s Ensatinib Hydrochloride Capsules Approved for New Indications in China. This is a highly selective next-generation anaplastic lymphoma kinase (ALK) inhibitor approved for the first-line treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Drug: Atezolizumab
Manufacturer: Roche
New indication: adjuvant immunotherapy after lung cancer surgery
Roche’s PD-L1 inhibitor atezolizumab was approved for a new indication in China, as a single drug for detection and evaluation of ≥1% tumor cell (TC) PD-L1 staining Adjuvant therapy for patients with stage II-IIIA NSCLC who have positive, surgically resected, platinum-based chemotherapy. As of the day of approval, this is the first and only indication for adjuvant immunotherapy after non-small cell lung cancer surgery approved in China, which is expected to further reduce the risk of disease recurrence in patients after lung cancer surgery.
Drug: Pratinib
Manufacturer: CStone Pharmaceuticals
New indication: RET-mutant medullary thyroid cancer
CStone’s RET inhibitor pratinib was approved in China for a new indication: for adults with advanced or metastatic RET-mutant medullary thyroid cancer requiring systemic therapy and Treatment of pediatric patients 12 years of age and older, and treatment of adults and children 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer requiring systemic therapy and refractory to radioactive iodine.
Drug: Tislelizumab
Manufacturer: BeiGene
New indication: adult advanced solid tumors
BeiGene’s anti-PD-1 mAb tislelizumab received seventh indication in China for the treatment of unresectable or metastatic microsatellite highly unstable or Mismatch repair gene deficiency in adult patients with advanced solid tumors.
Drugs: Bevacizumab Biosimilars
Manufacturer: Xinda Bio
New indications: cervical cancer, ovarian cancer
Innovent Biosimilar bevacizumab biosimilar approved in China for the 5th and 6th indications, respectively: combined with carboplatin and paclitaxel for the treatment of patients with First-line treatment in patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; combination with paclitaxel and cisplatin or paclitaxel and topotecan in patients with persistent, recurrent, or metastatic cervical cancer .
Drug: Rivaroxaban
Manufacturer: Bayer
New indication: Pediatric venous thromboembolism
Bayer’s factor Xa anticoagulant inhibitor rivaroxaban has been approved in China for a new indication for intravenous use in children and adolescents under 18 years old and weighing 30kg-50kg and over 50kg VTE treatment and prevention of VTE recurrence after initial non-oral anticoagulation for at least 5 days in patients with thromboembolism (VTE). Previously, the drug has been approved in China for the prevention and treatment of adult patients with venous thrombosis, chronic coronary disease or peripheral arterial disease after hip/knee replacement and other indications.
Drugs: Remazolam Besylate for Injection
Manufacturer: Renfu Pharmaceutical
New indication: induction and maintenance of general anesthesia
Remazolam besylate for injection jointly developed by Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical, and German company PAION, has been approved for a new indication in China. The new indication is “general anesthesia induction and maintenance”. The drug has previously been approved in China for sedation during colonoscopy.
Drugs: Bevacizumab Biosimilars
Manufacturing companies: Betta Pharmaceuticals, Tianguangshi Biology
New indications: recurrent glioblastoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, cervical cancer
The bevacizumab biosimilar jointly developed by Betta Pharmaceuticals and Tianguangshi Biotechnology has been approved for four new indications in China, namely recurrent glioblastoma, Epithelial ovarian, fallopian tube or primary peritoneal cancer, cervical cancer.
