Editor's Notes: New drugs in this article refer to
Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
First generic drugs in China*.
*"First generic drug in China" refers to the first generic drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization.
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In September 2022, China NMPA approved 15 new drugs, including 12 chemical drugs and 3 biological products.
Nanjing Biosnwill Medical's Edaravone Sublingual Tablet
AstraZeneca's Dapagliflozin Tablets
Bayer's Rivaroxaban Tablets
AstraZeneca's Olaparib Tablets
Yichang Humanwell Pharmaceutical's Clobazam Tablets
Jiangxi Yiyou Pharmaceutical's Bromhexine Hydrochloride Granules
Qilu Pharmaceutical's Aprepitant Injection
Hainan Poly Pharm's Terlipressin Injection
Inner Mongolia Baiyi Pharmaceutical's Compound Vitamins (13) for Injection
Staidson's Polyethylene Glycol Electrolytes Oral Solution
Staidson's Polyethylene Glycol Electrolytes Powder
Kelun Pharmaceutical's Ceftriaxone Sodium for Injection and Sodium Chloride Injection
Lepu Biopharma's Pucotenlimab Injection
Shanghai Junshi Biosciences' Toripalimab Injection
Novartis' Omalizumab Injection
The approval details are as follows.
1. Edaravone Sublingual Tablet
1 | Generic Name | Edaravone Sublingual Tablet |
2 | Brand Name | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application Type | New drug application (NDA) |
5 | Marketing Authorization Holder (MAH) | Nanjing Biosnwill Medical Co., Ltd. |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 422 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for inhibiting the progression of dysfunctions caused by amyotrophic lateral sclerosis (ALS). |
2. Dapagliflozin Tablets
1 | Generic Name | Dapagliflozin Tablets |
2 | Brand Name | FORXIGA (安达唐) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AstraZeneca AB |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 584 days |
8 | Priority Review | No |
9 | Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
10 | Indication(s) | Previously approved: Indicated ① as a single therapy / ② in combination with metformin hydrochloride / ③ in combination with insulin, all combined with diet and exercise to improve glycemic control for adults having type 2 diabetes mellitus. Limitation of use: Not recommended for treating type 1 diabetes mellitus or diabetic ketoacidosis. Newly approved on Sept. 2, 2022: Indicated for reducing the risk of end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression. |
3. Rivaroxaban Tablets
1 | Generic Name | Rivaroxaban Tablets |
2 | Brand Name | Xarelto (拜瑞妥) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer AG |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 624 days |
8 | Priority Review | No |
9 | Target(s) | Coagulation Factor X |
10 | Indication(s) | Previously approved: 1. Indicated for preventing venous thromboembolism (VTE) in adult patients who are going to receive elective hip/knee joint replacement surgery. 2. Indicated for treating deep vein thrombosis (DVT) in adult patients, and reducing the risk of recurrence of DVT and/or pulmonary embolism (PE) after acute DVT. 3. Indicated for reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and one or more risk factors (e.g., congestive heart failure, hypertension, ≥ 75 years old, diabetes, history of stroke or transient ischemic attack). Newly approved on Sept. 2, 2022: 4. Indicated for reducing the risk of major thrombotic vascular events (cardiovascular-disease-induced death, myocardial infarction, ischemic stroke, major amputation, and acute limb ischemia) for peripheral artery disease (PAD) patients who have recently received a lower extremity revascularization procedure (surgery or therapeutic intervention). |
4. Olaparib Tablets
1 | Generic Name | Olaparib Tablets |
2 | Brand Name | LYNPARZA (利普卓) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AstraZeneca AB |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 257 days |
8 | Priority Review | No |
9 | Target(s) | Poly (ADP-Ribose) Polymerase 1 (PARP); Poly (ADP-Ribose) Polymerase 2 (PARP2); Protein mono-ADP-ribosyltransferase PARP3 |
10 | Indication(s) | 1. Indicated for the maintenance treatment of germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are in complete or partial response to first-line platinum-based chemotherapy. 2. Indicated for the maintenance treatment of platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are in complete or partial response to platinum-based chemotherapy. |
5. Clobazam Tablets
1 | Generic Name | Clobazam Tablets |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA) |
5 | MAH | Yichang Humanwell Pharmaceutical Co., Ltd. |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 187 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | Benzodiazepine receptor (BZR); GABAA receptor (GABAAR) |
10 | Indication(s) | Indicated in combination therapy for treating seizures in patients no younger than two years old with Lennox-Gastaut syndrome (LGS). |
11 | Notes | First generic drug in China |
6. Bromhexine Hydrochloride Granules
1 | Generic Name | Bromhexine Hydrochloride Granules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Jiangxi Yiyou Pharmaceutical Co., Ltd. |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 551 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Indicated for treating acute and chronic bronchitis, asthma, bronchiectasis, and pneumoconiosis in patients whose viscid phlegm is difficult to be expectorated. |
11 | Notes | First generic drug in China |
7. Aprepitant Injection
1 | Generic Name | Aprepitant Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Qilu Pharmaceutical Co., Ltd. |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 598 days |
8 | Priority Review | No |
9 | Target(s) | Substance-P receptor (NK1) |
10 | Indication(s) | In combination with other antiemetic agents, the drug is indicated for preventing acute and delayed nausea and vomiting associated with initial and/or repeated courses of moderately and highly emetogenic cancer chemotherapy for adult patients with cancer. |
11 | Notes | First generic drug in China |
8. Terlipressin Injection
1 | Generic Name | Terlipressin Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Hainan Poly Pharm Co., Ltd. |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 809 days |
8 | Priority Review | No |
9 | Target(s) | Vasopressin V1 receptor |
10 | Indication(s) | 1. Indicated for treating bleeding in the gastrointestinal tract and genitourinary system, including bleeding caused by esophageal varices, gastric and duodenal ulcers, uterine bleeding caused by functional reasons or other reasons, and bleeding from giving birth or having abortion. 2. Indicated for treating post-surgery bleeding, especially in the abdominal and pelvic areas. 3. Local application in gynecological surgery, e.g., in the cervix. |
11 | Notes | First generic drug in China |
9. Compound Vitamins (13) for Injection
1 | Generic Name | Compound Vitamins (13) for Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Inner Mongolia Baiyi Pharmaceutical Co., Ltd. |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 1,273 days |
8 | Priority Review | Yes (ANDA according to the quality and equivalence evaluation standards for generic drugs) |
9 | Target(s) | / |
10 | Indication(s) | Indicated for preventing vitamin deficiency in adults or pediatric patients no younger than 11 years old who receive parenteral nutrition. |
11 | Notes | First generic drug in China |
10. Polyethylene Glycol Electrolytes Oral Solution
1 | Generic Name | Polyethylene Glycol Electrolytes Oral Solution |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Staidson (Beijing) Biopharmaceuticals Co., Ltd. |
6 | Approval Date | Sept. 23, 2022 |
7 | Time from Application Acceptance to Approval | 1,316 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | Used for cleansing the colon in preparation for colonoscopy or surgery. |
11 | Notes | First generic drug in China |
11. Polyethylene Glycol Electrolytes Powder
1 | Generic Name | Polyethylene Glycol Electrolytes Powder |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Staidson (Beijing) Biopharmaceuticals Co., Ltd. |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 1,310 days |
8 | Priority Review | Yes (pediatric drug) |
9 | Target(s) | / |
10 | Indication(s) | 1. Indicated for treating functional constipation; 2. Used for cleansing the colon in preparation for colon surgery, colonoscopy and other medical tests. |
11 | Notes | First generic drug in China |
12. Ceftriaxone Sodium for Injection and Sodium Chloride Injection
1 | Generic Name | Ceftriaxone Sodium for Injection and Sodium Chloride Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA |
5 | MAH | Hunan Kelun Pharmaceutical Co., Ltd. |
6 | Approval Date | Sept. 29, 2022 |
7 | Time from Application Acceptance to Approval | 1,871 days |
8 | Priority Review | No |
9 | Target(s) | Penicillin-binding proteins (PBPs) |
10 | Indication(s) | Indicated for treating pneumonia, bronchitis, peritonitis, and pleurisy caused by sensitive bacteria; infections of skin, soft tissue, urinary tract, biliary tract, bone & joint, eye, nose, mouth, and wound surface; sepsis and meningitis. |
11 | Notes | First generic drug in China |
13. Pucotenlimab Injection
1 | Generic Name | Pucotenlimab Injection |
2 | Brand Name | Pu You Heng (普佑恒) |
3 | Classification | Class 1 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Lepu Biopharma Co., Ltd. |
6 | Approval Date | Sept. 29, 2022 |
7 | Time from Application Acceptance to Approval | 442 days |
8 | Priority Review | No |
9 | Target(s) | / |
10 | Indication(s) | 1. Indicated for treating advanced solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have failed at least the first-line systemic treatment. 2. Indicated for treating unresectable or metastatic melanoma after the failure of systemic treatment. |
14. Toripalimab Injection
1 | Generic Name | Toripalimab Injection |
2 | Brand Name | Tuo Yi (拓益) |
3 | Classification | Class 2.2 therapeutic biological product |
4 | Application Type | BLA |
5 | MAH | Shanghai Junshi Biosciences Co., Ltd. |
6 | Approval Date | Sept. 19, 2022 |
7 | Time from Application Acceptance to Approval | 274 days |
8 | Priority Review | No |
9 | Target(s) | Programmed cell death protein 1 (PD-1) |
10 | Indication(s) | Previously approved: 1. Indicated for treating unresectable or metastatic melanoma after the failure of systemic treatment. 2. Indicated for the treatment of patients with relapsed or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of systemic therapy. 3. Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or the disease progresses within 12 months of neoadjuvant/adjuvant platinum-containing chemotherapy. 4. Indicated for first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine. 5. In combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/relapsed or distant metastatic esophageal squamous cell carcinoma. Newly approved on Sept. 19, 2022 6. In combination with pemetrexed and platinum for the first-line treatment of epidermal growth factor receptor (EGFR) gene mutation-negative, anaplastic lymphoma kinase (ALK)-negative, unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). |
15. Omalizumab Injection
1 | Generic Name | Omalizumab Injection |
2 | Brand Name | Xolair (茁乐) |
3 | Classification | Class 3.1 therapeutic biological product |
4 | Application Type | BLA, import |
5 | MAH | Novartis Europharm Limited |
6 | Approval Date | Sept. 2, 2022 |
7 | Time from Application Acceptance to Approval | 507 days |
8 | Priority Review | No |
9 | Target(s) | Immunoglobulin E (IgE) |
10 | Indication(s) | Indicated for treating moderate to severe persistent asthma in adults and pediatric patients whose symptoms are inadequately controlled by inhaled corticosteroids and inhaled long-acting beta2-adrenergic receptor agonists. |
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