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: the first generic chemical drug developed by a Chinese company and approved by China National Medical Products Administration (NMPA) with marketing authorization. The definition of “first generic drug” is commonly used in the Chinese pharma industry but not written in Chinese regulations.
Related Articles:
In Mar. 2023, China NMPA approved 15 new drugs, all of which are chemical drugs.
1. Raynovent’s Leritrelvir Tablets
2. Shanghai Haihe Biopharma’s Glumetinib Tablets
3. IPSEN PHARMA’s Triptorelin Pamoate for Injection
4. AstraZeneca’s Acalabrutinib Capsules (CALQUENCE)
5. Nobelpharma’s Sirolimus Gel (HYFTOR)
6. EVEREST MEDICINES’ Eravacycline Hydrochloride for Injection
7. Medac’s Methotrexate Injection (Prefilled)
8. Jiangsu Hengrui Pharmaceuticals’ Dexmedetomidine Hydrochloride Nasal Spray
9. Eli Lilly’s Baricitinib Tablets (OLUMIANT)
10. Bayer’s Darolutamide Tablets (NUBEQA)
11. Huaxia Shengsheng Pharmaceutical’s Linezolid and Sodium Chloride Injection (first generic)
12. Hunan Kelun Pharmaceutical’s Cefoxitin Sodium for Injection and Glucose Injection (first generic)
13. Xi'an Gelan Xintong Pharmaceutical’s Fosphenytoin Sodium Concentrated Solution for Injection (first generic)
14. Hainan Herui Pharmaceutical’s Mesalazine Enteric-coated Sustained-release Capsules (first generic)
15. Zhongrun Pharmaceutical’s Peramivir Injection (first generic)
The details are as follows.
1. Leritrelvir Tablets
1 | Generic Name | Leritrelvir Tablets |
2 | Brand Name | Le Rui Ling (乐睿灵) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | New drug application (NDA), domestic |
5 | Marketing Authorization Holder (MAH) | Guangdong Raynovent Biotech Co., Ltd. |
6 | Approval Date | 23/03/2023 |
7 | Time from Application Acceptance to Approval | Not revealed |
8 | Priority Review | Yes (conditional approval) |
9 | Target(s) | 3CL protease |
10 | Indication(s) | For treating adult patients with mild-to-moderate COVID-19 infection. |
2. Glumetinib Tablets
1 | Generic Name | Glumetinib Tablets |
2 | Brand Name | Hai Yi Tan (海益坦) |
3 | Classification | Class 1 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Shanghai Haihe Biopharma R&D Institute Co., Ltd. |
6 | Approval Date | 07/03/2023 |
7 | Time from Application Acceptance to Approval | 375 days |
8 | Priority Review | Yes (breakthrough therapy) |
9 | Target(s) | Hepatocyte growth factor receptor (c-Met) |
10 | Indication(s) | For the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping. |
3. Triptorelin Pamoate for Injection
1 | Generic Name | Triptorelin Pamoate for Injection |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | IPSEN PHARMA |
6 | Approval Date | 07/03/2023 |
7 | Time from Application Acceptance to Approval | 207 days |
8 | Priority Review | Yes (reason not revealed) |
9 | Target(s) | Gonadotropin-releasing hormone receptor (GnRH receptor) |
10 | Indication(s) | For the treatment of locally advanced or metastatic prostate cancer. |
4. Acalabrutinib Capsules
1 | Generic Name | Acalabrutinib Capsules |
2 | Brand Name | CALQUENCE (康可期) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | AstraZeneca Pty Ltd |
6 | Approval Date | 21/03/2023 |
7 | Time from Application Acceptance to Approval | 440 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase BTK |
10 | Indication(s) | For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. |
5. Sirolimus Gel
1 | Generic Name | Sirolimus Gel |
2 | Brand Name | HYFTOR |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Nobelpharma Co., Ltd. |
6 | Approval Date | 28/03/2023 |
7 | Time from Application Acceptance to Approval | 1,251 days |
8 | Priority Review | Yes (rare disease) |
9 | Target(s) | Mammalian target of rapamycin complex 1 (FKBP1A); Peptidyl-prolyl cis-trans isomerase FKBP1A (mTORC1) |
10 | Indication(s) | For the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. |
6. Eravacycline Hydrochloride for Injection
1 | Generic Name | Eravacycline Hydrochloride for Injection |
2 | Brand Name | Yi Jia (依嘉) |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | EVEREST MEDICINES (SINGAPORE) PTE. LTD. |
6 | Approval Date | 15/03/2023 |
7 | Time from Application Acceptance to Approval | 723 days |
8 | Priority Review | No |
9 | Target(s) | 30S ribosomal subunit |
10 | Indication(s) | For the treatment of complicated intra‑abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia colis, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older. |
7. Methotrexate Injection (Prefilled)
1 | Generic Name | Methotrexate Injection (Prefilled) |
2 | Brand Name | / |
3 | Classification | Class 5.1 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | medac Gesellschaft für klinische Spezialpräparate mbH |
6 | Approval Date | 24/03/2023 |
7 | Time from Application Acceptance to Approval | 470 days |
8 | Priority Review | Yes (reason not revealed yet) |
9 | Target(s) | Dihydrofolate Reductase (DHFR) |
10 | Indication(s) | For the treatment of severe recalcitrant disabling psoriasis, which is not adequately responsive to standard treatments. |
8. Dexmedetomidine Hydrochloride Nasal Spray
1 | Generic Name | Dexmedetomidine Hydrochloride Nasal Spray |
2 | Brand Name | / |
3 | Classification | Class 2.2 chemical drug |
4 | Application Type | NDA, domestic |
5 | MAH | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
6 | Approval Date | 15/03/2023 |
7 | Time from Application Acceptance to Approval | 532 days |
8 | Priority Review | No |
9 | Target(s) | Alpha-2 adrenergic receptor (ADRA2) |
10 | Indication(s) | For sedation/anti-anxiety treatment for adult patients before procedures. |
9. Baricitinib Tablets
1 | Generic Name | Baricitinib Tablets |
2 | Brand Name | OLUMIANT (艾乐明) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Eli Lilly Nederland B.V. |
6 | Approval Date | 24/03/2023 |
7 | Time from Application Acceptance to Approval | 438 days |
8 | Priority Review | No |
9 | Target(s) | Tyrosine-protein kinase JAK1; Tyrosine-protein kinase JAK2 |
10 | Indication(s) | Previously approved: For the treatment of adult patients with moderate-to-severe active rheumatoid arthritis who had inadequate response or intolerance to one or more anti-rheumatic medicines for improving the condition. Newly approved on Mar. 24, 2023: For the treatment of adult patients with severe alopecia areata. |
10. Darolutamide Tablets
1 | Generic Name | Darolutamide Tablets |
2 | Brand Name | NUBEQA (诺倍戈) |
3 | Classification | Class 2.4 chemical drug |
4 | Application Type | NDA, import |
5 | MAH | Bayer HealthCare Pharmaceuticals Inc. |
6 | Approval Date | 15/03/2023 |
7 | Time from Application Acceptance to Approval | 325 days |
8 | Priority Review | No |
9 | Target(s) | Androgen receptor |
10 | Indication(s) | Previously approved: For the treatment of adult patients with non-metastatic castration resistant prostate cancer (nmCRPC); Newly approved on Mar. 15, 2023: For the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). |
11. Linezolid and Sodium Chloride Injection
1 | Generic Name | Linezolid and Sodium Chloride Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | Abbreviated new drug application (ANDA), domestic |
5 | MAH | Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd. |
6 | Approval Date | 24/03/2023 |
7 | Time from Application Acceptance to Approval | 554 days |
8 | Priority Review | No |
9 | Target(s) | Monoamine Oxidase A |
10 | Indication(s) | 1. For the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae. 2. For the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only). 3. For the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers. 4. For the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia. |
11 | Note | First generic drug in China |
12. Cefoxitin Sodium for Injection and Glucose Injection
1 | Generic Name | Cefoxitin Sodium for Injection and Glucose Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Hunan Kelun Pharmaceutical Co., Ltd. |
6 | Approval Date | 24/03/2023 |
7 | Time from Application Acceptance to Approval | 421 days |
8 | Priority Review | No |
9 | Target(s) | Monoamine Oxidase A |
10 | Indication(s) | For mixed infections caused by aerobic and anaerobic bacteria, and infections caused by sensitive β-lactamase-producing bacteria. |
11 | Note | First generic drug in China |
13. Fosphenytoin Sodium Concentrated Solution for Injection
1 | Generic Name | Fosphenytoin Sodium Concentrated Solution for Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Xi'an Gelan Xintong Pharmaceutical Co., Ltd. |
6 | Approval Date | 15/03/2023 |
7 | Time from Application Acceptance to Approval | 587 days |
8 | Priority Review | No |
9 | Target(s) | Sodium channel |
10 | Indication(s) | 1. For the prevention and treatment of seizures occurring in the perioperative period or during neurosurgery. 2. For the treatment of generalized tonic-clonic status epilepticus. |
11 | Note | First generic drug in China |
14. Mesalazine Enteric-coated Sustained-release Capsules
1 | Generic Name | Mesalazine Enteric-coated Sustained-release Capsules |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Hainan Herui Pharmaceutical Co., Ltd. |
6 | Approval Date | 15/03/2023 |
7 | Time from Application Acceptance to Approval | 618 days |
8 | Priority Review | No |
9 | Target(s) | Serine/threonine-protein phosphatase 2A (PP2A) |
10 | Indication(s) | For the maintenance of remission of ulcerative colitis in adults. |
11 | Note | First generic drug in China |
15. Peramivir Injection
1 | Generic Name | Peramivir Injection |
2 | Brand Name | / |
3 | Classification | Class 3 chemical drug |
4 | Application Type | ANDA, domestic |
5 | MAH | Zhongrun Pharmaceutical (Group) Co., Ltd. |
6 | Approval Date | 24/03/2023 |
7 | Time from Application Acceptance to Approval | 777 days |
8 | Priority Review | No |
9 | Target(s) | Exo-alpha-sialidase |
10 | Indication(s) | For the treatment of influenza A and influenza B. |
11 | Note | First generic drug in China |
Please contact BaiPharm if you need more details of drug approvals in China.
