On December 25, 2023, China’s National Health Commission (NHC) and four other authorities jointly issued the third list of encouraged generic drugs. The list comprises 39 drugs based on their active ingredients, encompassing a total of 75 different strengths.
The foremost purpose for releasing this list is to address the clinical needs within the country. Many of the drugs included in the list have not yet received approval in China but have been approved overseas. Examples of such drugs include:
Patisiran, a small interfering RNA (siRNA) medication, indicated for the treatment of genetic transthyretin-mediated amyloidosis in adults, and
Voclosporin, an oral medication, indicated in combination with immunosuppressants for the treatment of active lupus nephritis in adults.
While some of the drugs in the list have already been approved in China, there is still a risk of short supply due to the high demand of clinical settings. To address this issue, the authorities are encouraging the industry to develop these drugs, including facilitating clinical trials, prioritizing their review and approval process, as well as supporting research on critical generic technologies.
Prior to this third list, China had previously released two lists of encouraged generics, which included a total of 51 drugs based on their active ingredients. Since the two lists were issued, 33 out of the 51 listed drugs have been approved in China, with 14 of them approved via priority review. Furthermore, 12 out of the approved generics have entered the National Reimbursement Drug List (NRDL), which promotes their availability and coverage under the national basic healthcare insurance.
For the complete third list of encouraged generic drugs, please refer to the table below. To access information on the previous two lists, you can visit the BaiPharm Database.
Table: The third list of encouraged generic drugs in China
No. | API | Dosage form | Strength |
3-1 | Binimetinib | Tablet | 15 mg |
3-2 | Voclosporin | Capsule | 7.9 mg |
3-3 | Idelalisib | Tablet | 0.1 g |
3-3 | Idelalisib | Tablet | 0.15 g |
3-4 | Eltrombopag | Tablet | 25 mg |
3-4 | Eltrombopag | Tablet | 50 mg |
3-5 | Raltegravir | Powder for Suspension | 0.1 g |
3-6 | Lifitegrast | Ophthalmic Solution | 0.05 |
3-7 | Lurbinectedin | Injection | 4 mg |
3-8 | Lusutrombopag | Tablet | 3 mg |
3-9 | Pimavanserin | Tablet | 10 mg |
3-9 | Pimavanserin | Tablet | 17 mg |
3-9 | Pimavanserin | Capsule | 34 mg |
3-10 | Relugolix | Tablet | 0.12 g |
3-10 | Relugolix | Tablet | 40 mg |
3-11 | Telavancin | Powder for Injection | 0.25 g |
3-11 | Telavancin | Powder for Injection | 0.75 g |
3-12 | Tucatinib | Tablet | 50 mg |
3-12 | Tucatinib | Tablet | 0.15 g |
3-13 | Fostamatinib | Tablet | 0.1 g |
3-13 | Fostamatinib | Tablet | 0.15 g |
3-14 | Naloxegol | Tablet | 12.5 mg |
3-14 | Naloxegol | Tablet | 25 mg |
3-15 | Patisiran | Injection | 5 ml: 10 mg |
3-16 | Rucaparib | Tablet | 0.25 g |
3-16 | Rucaparib | Tablet | 0.3 g |
3-17 | Tivozanib | Capsule | 0.89 mg |
3-17 | Tivozanib | Capsule | 1.34 mg |
3-18 | Aripiprazole | Extended-release Injection | 1.6 ml: 0.441 g |
3-18 | Aripiprazole | Extended-release Injection | 2.4 ml: 0.675 g |
3-18 | Aripiprazole | Extended-release Injection | 3.2 ml: 0.96 g |
3-19 | Armodafinil | Tablet | 50 mg |
3-19 | Armodafinil | Tablet | 0.2 g |
3-20 | Asenapine | Sublingual Tablet | 2.5 mg |
3-20 | Asenapine | Sublingual Tablet | 5 mg |
3-20 | Asenapine | Sublingual Tablet | 10 mg |
3-21 | Olanzapine + Samidorphan, combinations | Tablet | 15 mg: 5 mg olanzapine and 10 mg samidorphan |
3-21 | Olanzapine + Samidorphan, combinations | Tablet | 20 mg: 10 mg olanzapine and 10 mg samidorphan |
3-21 | Olanzapine + Samidorphan, combinations | Tablet | 25 mg: 15 mg olanzapine and 10 mg samidorphan |
3-21 | Olanzapine + Samidorphan, combinations | Tablet | 30 mg: 20 mg olanzapine and 10 mg samidorphan |
3-22 | Bempedoic Acid | Tablet | 0.18 g |
3-23 | Vandetanib | Tablet | 0.1 g |
3-23 | Vandetanib | Tablet | 0.3 g |
3-24 | Fidaxomicin | Tablet | 0.2 g |
3-25 | Gabapentin Enacarbil | Extended-release Tablets | 0.3 g |
3-25 | Gabapentin Enacarbil | Extended-release Tablets | 0.6 g |
3-26 | Cabozantinib | Capsule | 20 mg |
3-26 | Cabozantinib | Capsule | 80 mg |
3-26 | Cabozantinib | Tablet | 20 mg |
3-26 | Cabozantinib | Tablet | 40 mg |
3-26 | Cabozantinib | Tablet | 60 mg |
3-27 | Cabotegravir | Extended-release Injection | 3 ml: 0.6 g |
3-28 | Revefenacin | Solution for Inhalation | 3 ml: 0.175 mg |
3-29 | Lisdexamfetamine | Capsule | 10 mg |
3-29 | Lisdexamfetamine | Capsule | 20 mg |
3-29 | Lisdexamfetamine | Capsule | 40 mg |
3-29 | Lisdexamfetamine | Chewable Tablet | 10 mg |
3-29 | Lisdexamfetamine | Chewable Tablet | 20 mg |
3-29 | Lisdexamfetamine | Chewable Tablet | 40 mg |
3-30 | Relugolix + Estradiol + Norethindrone, combinations | Tablet | 41.5 mg: 40mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone |
3-31 | Eplerenone | Tablet | 25 mg |
3-31 | Eplerenone | Tablet | 50 mg |
3-32 | Nitazoxanide | Tablet | 0.5 g |
3-32 | Nitazoxanide | Suspension | 5 ml: 0.1 g |
3-33 | Clobazam | Tablet | 20 mg |
3-33 | Clobazam | Film | 5 mg |
3-33 | Clobazam | Film | 10 mg |
3-33 | Clobazam | Film | 20 mg |
3-33 | Clobazam | Suspension | 1 ml: 2.5 mg |
3-34 | Gallium-68 Dotatate | Injection | 10 ml: 20 mCi |
3-35 | Fluorine-18 Fluorodopa | Injection | 10 ml: 40.5 mCi |
3-36 | Fluorine-18 Fluoroestradiol | Injection | 10 ml: 40.5 mCi |
3-37 | Fluorine-18 Sodium Fluoride | Injection | 10 ml: 40.5 mCi |
3-38 | Fluorine-18 Flortaucipir/18F-AV1451 | Injection | 10 ml: 40.5 mCi |
3-39 | lodine I-123 Iobenguane/MIBG | Injection | 10 ml: 20 mCi |
Related: How to Submit Abbreviated New Drug Application (ANDA) for Generic Drugs in China
