Editor's Notes: New drugs in this article refer to any of the following drugs:
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 term “first generic drug” is commonly used in the Chinese pharma industry but not specified in Chinese regulations.
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In January 2024, China NMPA approved 18 new drugs, among which 14 are chemical drugs and 4 are biological products.
1. Jiangsu Hengrui Pharmaceuticals’ Tegileridine Fumarate Injection (innovative drug)
2. Huisheng Pharm’s Ganagliflozin Proline Tablets (innovative drug)
3. Qilu Pharmaceutical’s Iruplinalkib Tablets (innovative drug)
4. Pfizer’s Rimegepant Sulfate Orally Disintegrating Tablets
5. ApicHope Pharmaceutical’s Amlodipine Besilate for Suspension
6. Yifan Pharmaceutical’s Diazoxide Oral Suspension (first generic in China)
7. Hangzhou Anprime Biopharm’s Sevelamer Carbonate for Suspension (first generic in China)
8. Hunan Pudao Pharmaceutical Technology’s Ebastine Oral Solution (first generic in China)
9. Kelun Industry Group’s Eltrombopag Olamine Tablets (first generic in China)
10. Qilu Pharmaceutical’s Eltrombopag Olamine Tablets (first generic in China)
11. CTTQ’s Eltrombopag Olamine Tablets (first generic in China)
12. Jiangsu Aosaikang Pharmaceutical’s Eltrombopag Olamine Tablets (first generic in China)
13. Hefei Chengzhi Biopharmaceutical’s Itraconazole Oral Solution (first generic in China)
14. Hwang's Pharmaceutical’s Itraconazole Oral Solution (first generic in China)
15. Eisai’s Lecanemab Injection (innovative drug)
16. Eli Lilly’s Galcanezumab Injection
17. Novo Nordisk’s Semaglutide Tablet
18. MSD’s Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine
1. Tegileridine Fumarate Injection
Generic name | Tegileridine Fumarate Injection |
Brand | 艾苏特 (Ai Su Te) |
Classification | Class 1 chemical drug |
Application type | New drug application (NDA), domestic |
Marketing authorization holder (MAH) | |
Approved | 31/01/2024 |
Time from application acceptance to approval | Not revealed |
Priority review | No |
Target(s) | Mu-type opioid receptor (OPRM1) |
Indication(s) | Indicated for moderate to severe pain after abdominal surgery. |
2. Ganagliflozin Proline Tablets
Generic name | Ganagliflozin Proline Tablets |
Brand | 惠优静 (Hui You Jing) |
Classification | Class 1 chemical drug, domestic |
Application type | NDA |
MAH | |
Approved | 16/01/2024 |
Time from acceptance to approval | 687 days |
Priority review | No |
Target(s) | Sodium/glucose cotransporter 2 (SLC5A2) |
Indication(s) | Indicated for monotherapy or for use in combination with metformin hydrochloride to improve blood glucose control in adult patients with type 2 diabetes. |
3. Iruplinalkib Tablets
Generic name | Iruplinalkib Tablets |
Brand | 启欣可 (Qi Xin Ke) |
Classification | Class 1 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 280 days |
Priority review | No |
Target(s) | ALK tyrosine kinase receptor; Proto-oncogene tyrosine-protein kinase ROS1 |
Indication(s) | Previously approved: Indicated for the treatment of locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have experienced disease progression after prior treatment with crizotinib or who are intolerant to crizotinib. Newly approved: Indicated for the treatment of locally advanced or metastatic ALK-positive NSCLC. |
4. Rimegepant Sulfate Orally Disintegrating Tablets
Generic name | Rimegepant Sulfate Orally Disintegrating Tablets |
Brand | 乐泰可(NURTEC) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 23/01/2024 |
Time from acceptance to approval | 504 days |
Priority review | No |
Target(s) | Calcitonin gene-related peptide receptor (CGRP receptor) |
Indication(s) | Indicated for the acute treatment of migraine with or without aura in adults. |
5. Amlodipine Besilate for Suspension
Generic name | Amlodipine Besilate for Suspension |
Brand | / |
Classification | Class 2.2 chemical drug |
Application type | NDA, domestic |
MAH | |
Approved | 23/01/2024 |
Time from acceptance to approval | 599 days |
Priority review | No |
Target(s) | Long-lasting type calcium channel (LTCC) |
Indication(s) | 1. Hypertension Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. 2. Coronary artery disease (CAD) l Chronic stable angina Indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. l Vasospastic Angina (Prinzmetal's or Variant Angina) Indicated for the treatment of confirmed or suspected vasospastic angina; may be used as monotherapy or in combination with other antianginal drugs. l Angiographically Documented CAD In patients with recently documented CAD by angiography, an ejection fraction ≥ 40%, and without heart failure, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. |
6. Diazoxide Oral Suspension
Generic name | Diazoxide Oral Suspension |
Brand | / |
Classification | Class 3 chemical drug |
Application type | Abbreviated new drug application (ANDA), domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 526 days |
Priority review | Yes (In shortage and for rare disease) |
Target(s) | ATP-sensitive potassium channel (KATP channel) |
Indication(s) | Indicated for the treatment of pediatric patients with hypoglycemia associated with insulinoma or hyperinsulinemia. |
Notes | First generic in China |
7. Sevelamer Carbonate for Suspension
Generic name | Sevelamer Carbonate for Suspension |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 23/01/2024 |
Time from acceptance to approval | 525 days |
Priority review | No |
Target(s) | / |
Indication(s) | Indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis or who are not yet on dialysis and with serum phosphate levels ≥ 1.78mmol/L. |
Notes | First generic in China |
8. Ebastine Oral Solution
Generic name | Ebastine Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | Hunan Pudao Pharmaceutical Technology, subsidiary of Jiudian Pharmaceutical |
Approved | 16/01/2024 |
Time from acceptance to approval | 641 days |
Priority review | No |
Target(s) | Histamine H1 receptor (H1R) |
Indication(s) | Indicated for the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis, as well as for the symptomatic treatment of chronic idiopathic urticaria. |
Notes | First generic in China |
9. Eltrombopag Olamine Tablets
Generic name | Eltrombopag Olamine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 1,064 days |
Priority review | No |
Target(s) | Thrombopoietin receptor (TPO-R) |
Indication(s) | Indicated for the treatment of thrombocytopenia in adult patients 18 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or other therapies. The drug should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. |
Notes | First generic in China |
10. Eltrombopag Olamine Tablets
Generic name | Eltrombopag Olamine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 1,084 days |
Priority review | No |
Target(s) | Thrombopoietin receptor (TPO-R) |
Indication(s) | Indicated for the treatment of thrombocytopenia in adult patients 18 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or other therapies. The drug should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. |
Notes | First generic in China |
11. Eltrombopag Olamine Tablets
Generic name | Eltrombopag Olamine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 1,284 days |
Priority review | No |
Target(s) | Thrombopoietin receptor (TPO-R) |
Indication(s) | Indicated for the treatment of thrombocytopenia in adult patients 18 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or other therapies. The drug should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. |
Notes | First generic in China |
12. Eltrombopag Olamine Tablets
Generic name | Eltrombopag Olamine Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Jiangsu Aosaikang Pharmaceutical Co., Ltd. |
Approved | 09/01/2024 |
Time from acceptance to approval | 1,447 days |
Priority review | No |
Target(s) | Thrombopoietin receptor (TPO-R) |
Indication(s) | Indicated for the treatment of thrombocytopenia in adult patients 18 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or other therapies. The drug should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. |
Notes | First generic in China |
13. Itraconazole Oral Solution
Generic name | Itraconazole Oral Solution |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 928 days |
Priority review | No |
Target(s) | Hedgehog protein (HH protein); Lanosterol 14-alpha demethylase (CYP51A1) |
Indication(s) | 1. Indicated for the treatment of oropharyngeal and/or esophageal candidiasis in HIV-positive or immunocompromised patients. 2. Indicated for the prevention of invasive fundal infections in patients with hematological malignancies, bone marrow transplant recipients, and patients expected to have neutropenia (i.e.,<500 neutrophils/μl) who are susceptible to itraconazole when standard treatment is inappropriate. Currently, clinical efficacy data is insufficient for the prevention of aspergillosis. 3. Indicated for sequential therapy in the empirical treatment regimen with itraconazole injection in patients with febrile neutropenia suspected of having systemic fungal infection. |
Notes | First generic in China |
14. Itraconazole Oral Solution
Generic name | Itraconazole Oral Solution |
Brand | / |
Classification | Class 5.2 chemical drug |
Application type | ANDA, import |
MAH | |
Approved | 09/01/2024 |
Time from acceptance to approval | 928 days |
Priority review | No |
Target(s) | Hedgehog protein (HH protein); Lanosterol 14-alpha demethylase (CYP51A1) |
Indication(s) | 1. Indicated for the treatment of oropharyngeal and/or esophageal candidiasis in HIV-positive or immunocompromised patients. 2. Indicated for the prevention of invasive fundal infections in patients with hematological malignancies, bone marrow transplant recipients, and patients expected to have neutropenia (i.e.,<500 neutrophils/μl) who are susceptible to itraconazole when standard treatment is inappropriate. Currently, clinical efficacy data is insufficient for the prevention of aspergillosis. 3. Indicated for sequential therapy in the empirical treatment regimen with itraconazole injection in patients with febrile neutropenia suspected of having systemic fungal infection. |
Notes | First generic in China |
15. Lecanemab Injection
Generic name | Lecanemab Injection |
Brand | 乐意保 (Leqembi) |
Classification | Class 1 therapeutic biological product |
Application type | Biologics license application (BLA), import |
MAH | |
Approved | 05/01/2024 |
Time from acceptance to approval | 379 days |
Priority review | Innovative with urgent needs and in shortage, or for the treatment of major infectious disease or rare disease |
Target(s) | Amyloid-beta (Abeta) |
Indication(s) | Indicated for the treatment of mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia. |
16. Galcanezumab Injection
Generic name | Galcanezumab Injection |
Brand | 恩加乐 (Emgality) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 05/01/2024 |
Time from acceptance to approval | 528 days |
Priority review | No |
Target(s) | Calcitonin gene-related peptide (CGRP); Calcitonin gene-related peptide receptor (CGRP receptor) |
Indication(s) | Indicated for preventive treatment of episodic migraine in adults. |
17. Semaglutide Tablet
Generic name | Semaglutide Tablet |
Brand | 诺和忻 (Rybelsus) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | |
Approved | 23/01/2024 |
Time from acceptance to approval | 606 days |
Priority review | No |
Target(s) | Glucagon-like peptide 1 receptor (GLP-1R) |
Indication(s) | Indicated for the treatment of type 2 diabetes. |
18. Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine
Generic name | Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine |
Brand | 佳达修 9 (GARDASIL 9) |
Classification | Class 3.1 prophylactic biological product |
Application type | BLA, import |
MAH | |
Approved | 05/01/2024 |
Time from acceptance to approval | 308 days |
Priority review | No |
Target(s) | Human papillomavirus (HPV) |
Indication(s) | Indicated for the prevention of l cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; l cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3, as well as adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; l persistent infection caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Previously approved: 1. Three doses for the aforementioned prevention in women aged 9-45 years old. Newly approved: 2. Two doses for the aforementioned prevention in women aged 9-14 years old. |
Contact BaiPharm if you need more details of drug approvals in China.
