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 definition of “first generic drug” is commonly used in the Chinese pharma industry but not written in Chinese regulations.
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In October 2023, China NMPA approved 15 new drugs, among which 12 are chemical drugs and 3 are biological products.
BMS’ Deucravacitinib Tablets (SOTYKTU)
Pfizer’s Ritlecitinib Tosylate Capsules (LITFULO)
Janssen-Cilag International’s Rilpivirine Injection
Luye Pharma’s Rivastigmine Twice Weekly Transdermal Patch
Abbvie’s Upadacitinib Sustained-release Tablets (RINVOQ)
Poly Pharm’s Fluconazole for Suspension (first generic in China)
Nanjing Zeheng Pharma’s Salbutamol Sulfate Oral Solution
Hunan Pudao Medical Technology’s Loxoprofen Sodium Oral Solution (first generic in China)
Wanbang Biopharma’s Osimertinib Mesylate Tablets (first generic in China)
Huadong Medicine’s Macitentan Tablets (first generic in China)
NJCTTQ’s Macitentan Tablets (first generic in China)
Sino Therapeutics’ Macitentan Tablets (first generic in China)
Pfizer’s Sugemalimab Injection (Cejemly)
Alexion’s Eculizumab Injection (Soliris)
Swedish Orphan Biovitrum’s Anakinra injection (Kineret)
1. Deucravacitinib Tablets
Generic name | Deucravacitinib Tablets |
Brand | 颂狄多 (SOTYKTU) |
Classification | Class 1 chemical drug |
Application type | New drug application (NDA), import |
Marketing authorization holder (MAH) | |
Approved | 18/10/2023 |
Time from application acceptance to approval | 460 days |
Priority review | No |
Target(s) | Non-receptor tyrosine-protein kinase TYK2 |
Indication(s) | For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
2. Ritlecitinib Tosylate Capsules
Generic name | Ritlecitinib Tosylate Capsules |
Brand | 乐复诺 (LITFULO) |
Classification | Class 1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 18/10/2023 |
Acceptance to approval | 403 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Tyrosine-protein kinase JAK3 |
Indication(s) | For the treatment of severe alopecia areata, including alopecia totalis and alopecia universalis, in adults and adolescents 12 years and older who are suitable for systemic therapy. |
3. Rilpivirine Injection
Generic name | Rilpivirine Injection |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 18/10/2023 |
Acceptance to approval | 713 days |
Priority review | No |
Target(s) | Reverse transcriptase (RTase) |
Indication(s) | Used in combination with Cabotegravir Injection (VOCABRIA) for the treatment of human immunodeficiency virus type 1 (HIV-1) infected patients who have achieved virological suppression. |
4. Rivastigmine Twice Weekly Transdermal Patch
Generic name | Rivastigmine Twice Weekly Transdermal Patch |
Brand | / |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 27/10/2023 |
Acceptance to approval | 562 days |
Priority review | No |
Target(s) | Acetylcholinesterase (AChE) |
Indication(s) | For the treatment of symptoms of mild and moderate Alzheimer’s disease. |
5. Upadacitinib Sustained-release Tablets
Generic name | Upadacitinib Sustained-release Tablets |
Brand | 瑞福 (RINVOQ) |
Classification | Class 5.1 chemical drug |
Application type | NDA, import |
MAH | |
Approved | 24/10/2023 |
Acceptance to approval | 288 days |
Priority review | No |
Target(s) | Tyrosine-protein kinase JAK1 |
Indication(s) | 1) For the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). 2) For the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. |
6. Fluconazole for Suspension
Generic name | Fluconazole for Suspension |
Brand | / |
Classification | Class 3 chemical drug |
Application type | Abbreviated new drug application (ANDA), domestic |
MAH | |
Approved | 12/10/2023 |
Acceptance to approval | 723 days |
Priority review | No |
Target(s) | Lanosterol 14-alpha demethylase (CYP51A1) |
Indication(s) | 1) For the treatment of the following fungal infections in adult patients: cryptococcal meningitis; coccidioidomycosis; invasive candidiasis; mucosal candidiasis; acute or recurrent vaginal candidiasis; candidal balanitis; dermatomycoses, including tinea pedis, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis; tinea unguium (onychomycosis). 2) For preventing the following fungal infections in adult patients: - Preventing the recurrence of cryptococcal meningitis in patients with a high risk of recurrence; - Preventing the oropharyngeal or esophageal candidiasis in HIV-infected patients with a high risk of recurrence; - Reducing the recurrence of vaginal candidiasis rate (four or more attacks per year); - Preventing Candida infection in patients with neutropenia (e.g., patients with hematological malignancies receiving chemotherapy or patients undergoing hematopoietic stem cell transplantation). 3) - For the treatment of mucosal candidiasis (oropharynx, esophagus), invasive candidiasis, and cryptococcal meningitis in full-term neonates, infants, toddlers, children, and adolescents aged 0 to 17 years old; - For the prevention of Candida infection in immunocompromised patients; - Indicated as maintenance therapy for preventing the recurrence of cryptococcal meningitis in pediatric patients with a high risk for recurrence. |
Notes | First generic in China |
7. Salbutamol Sulfate Oral Solution
Generic name | Salbutamol Sulfate Oral Solution |
Brand | / |
Classification | Class 3 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 24/10/2023 |
Acceptance to approval | 518 days |
Priority review | No |
Target(s) | Beta-2 adrenergic receptor (ADRB2) |
Indication(s) | For the treatment of airway obstruction, such as bronchial asthma, chronic obstructive pulmonary disease (COPD), and bronchial asthma in patients with asthmatic tracheitis and/or emphysema. |
Notes | First generic in China |
8. Loxoprofen Sodium Oral Solution
Generic name | Loxoprofen Sodium Oral Solution |
Brand | / |
Classification | Class 3.1 chemical drug |
Application type | ANDA, domestic |
MAH | Hunan Pudao Medical Technology Co., Ltd. |
Approved | 24/10/2023 |
Acceptance to approval | 592 days |
Priority review | No |
Target(s) | Cyclooxygenase |
Indication(s) | - Indicated for rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of the shoulder, neck, shoulder, and carpel tunnel syndrome, toothache; - Indicated for anti-inflammation and analgesia after surgery, trauma, and tooth extraction; - Indicated for fever relief and analgesia caused by acute upper respiratory infections (including those accompanied by acute bronchitis). |
Notes | First generic in China |
9. Osimertinib Mesylate Tablets
Generic name | Osimertinib Mesylate Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Wanbang Biopharmaceuticals, a subsidiary of Fosun Pharma |
Approved | 24/10/2023 |
Acceptance to approval | 895 days |
Priority review | No |
Target(s) | EGFR T790M mutation |
Indication(s) | For the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as confirmed by a test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. |
Notes | First generic in China |
10. Macitentan Tablets
Generic name | Macitentan Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., subsidiary of Huadong Medicine |
Approved | 12/10/2023 |
Acceptance to approval | 1,017 days |
Priority review | No |
Target(s) | Endothelin receptor type B (ET-B) |
Indication(s) | Indicated as an endothelin receptor antagonist (ERA) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with macitentan monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients and idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%). |
Notes | First generic in China |
11. Macitentan Tablets
Generic name | Macitentan Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 12/10/2023 |
Acceptance to approval | 1,498 days |
Priority review | No |
Target(s) | ET-B |
Indication(s) | Indicated as an endothelin receptor antagonist (ERA) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with macitentan monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients and idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%). |
Notes | First generic in China |
12. Macitentan Tablets
Generic name | Macitentan Tablets |
Brand | / |
Classification | Class 4 chemical drug |
Application type | ANDA, domestic |
MAH | |
Approved | 12/10/2023 |
Acceptance to approval | 1,507 days |
Priority review | No |
Target(s) | ET-B |
Indication(s) | Indicated as an endothelin receptor antagonist (ERA) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with macitentan monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients and idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%). |
Notes | First generic in China |
13. Sugemalimab Injection
Generic name | Sugemalimab Injection |
Brand | 择捷美 (Cejemly) |
Classification | Class 2.2 therapeutic biological product |
Application type | Biologics License Application (BLA), domestic |
MAH | Pfizer Investment Co., Ltd. |
Approved | 27/10/2023 |
Acceptance to approval | 414 days |
Priority review | Yes (breakthrough therapy) |
Target(s) | Programmed cell death 1 ligand 1 (PD-1) |
Indication(s) | Previously approved: 1. In combination with pemetrexed and carboplatin, the drug is indicated for the first-line treatment of non-small cell lung cancer (NSCLC) that is EGFR mutation-negative, ALK-negative, metastatic, and non-squamous. In combination with paclitaxel and carboplatin, the drug is indicated for the first-line treatment of metastatic squamous NSCLC. 2. Indicated for the treatment of patients with unresectable stage III NSCLC which didn't progress after platinum-based concurrent or sequential chemoradiotherapy. Newly approved: 3. Indicated for treating relapsed or refractory extranodal natural killer (NK) T-cell lymphoma (R/R ENKTL). |
14. Eculizumab Injection
Generic name | Eculizumab Injection |
Brand | 舒立瑞 (Soliris) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | Alexion Europe SAS |
Approved | 12/10/2023 |
Acceptance to approval | 292 days |
Priority review | No |
Target(s) | / |
Indication(s) | Previously approved: 1. For the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and pediatric patients. 2. For the treatment of refractory generalized myasthenia gravis (gMG) in adult patients who are acetylcholine receptor (AChR) antibody-positive. Newly approved: 3. For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. |
15. Anakinra injection
Generic name | Anakinra injection |
Brand | 安络定 (Kineret) |
Classification | Class 3.1 therapeutic biological product |
Application type | BLA, import |
MAH | Swedish Orphan Biovitrum AB (publ) |
Approved | 27/10/2023 |
Acceptance to approval | 465 days |
Priority review | Yes (other situations eligible for priority review) |
Target(s) | Interleukin-1 receptor type 1 (IL1R1) |
Indication(s) | For the treatment of autoinflammatory periodic fever syndrome (for the treatment of Familial Mediterranean Fever) in adults, adolescents, children, and infants 8 months and older (weighing at least 10 kg). The drug should be used in combination with colchicine. |
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