YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 147 drug applications between 14 March 2021 and 20 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 19, covering 11 drug names.
2021/03/14 – 2021/03/20
- New acceptances this week
- 147
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
147filings, 19 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 73 |
| Import | 23 |
| Generic | 19 |
| New drug | 15 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 121 |
| Therapeutic biologic | 13 |
| TCM | 7 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
| In vitro diagnostic reagent | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Argatroban Injection | 3 | 3 | 2 |
| 2 | Sodium Valproate Concentrated Solution for Injection | 3 | 1 | 0 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 5 | Febuxostat Tablets | 2 | 1 | 12 |
| 6 | 氯化钾缓释片(I) · No verified English name | 1 | 1 | 0 |
| 7 | Lormetazepam Injection | 1 | 1 | 0 |
| 8 | Metoprolol Succinate Sustained-release Tablets | 1 | 1 | 4 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 1 | 1 | 10 |
| 10 | Olprinone Hydrochloride Injection | 1 | 1 | 1 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
84 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 9 | 5 | 0 |
| 2 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 3 | LABORATORIOS FARMACEUTICOS ROVI S.A. | 5 | 1 | 0 |
| 4 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 5 | Loxo Oncology Inc. | 4 | 1 | 0 |
| 6 | Mirum Pharmaceuticals Inc. | 4 | 1 | 0 |
| 7 | Pfizer Healthcare Ireland | 4 | 1 | 0 |
| 8 | Novartis Pharma Schweiz AG | 3 | 2 | 0 |
| 9 | Eli Lilly and Company | 3 | 1 | 0 |
| 10 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 3 | 1 | 3 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
35 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/20Import · Class 1 | Maralixibat口服溶液 · No verified English nameJXHL2100100 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液 · No verified English nameJXHL2100099 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液 · No verified English nameJXHL2100098 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Maralixibat口服溶液 · No verified English nameJXHL2100097 | Mirum Pharmaceuticals Inc. |
| 2021/03/20Import · Class 1 | Atrasentan片 · No verified English nameJXHL2100096 | Chinook Therapeutics U.S. Inc. |
| 2021/03/20Import · Class 1 | LOXO-305 · No verified English nameJXHL2100093 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305 · No verified English nameJXHL2100092 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305 · No verified English nameJXHL2100091 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 1 | LOXO-305 · No verified English nameJXHL2100090 | Loxo Oncology Inc. |
| 2021/03/20Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2100089 | Eisai Europe Ltd. |
| 2021/03/20Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2100088 | Eisai Europe Ltd. |
| 2021/03/20New drug · Class 1 | 阿基仑赛注射液 · No verified English nameCXSL2100098 | Fu Xing Kai Te Bio Technology Co., Ltd. romanized |
| 2021/03/19New drug · Class 2.4 | Tenofovir alafenamide Fumarate TabletsCXHS2100010 | Hua Bei Pharmaceutical Hua Kun Hebei Bio Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2021/03/19New drug · Class 1 | ASC42片 · No verified English nameCXHL2101008 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/03/19New drug · Class 1 | ASC42片 · No verified English nameCXHL2101007 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101023 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101022 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2101021 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/03/18New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101005 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/03/18New drug · Class 1 | HTD1801胶囊 · No verified English nameCXHL2100190 | Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized |
| 2021/03/17Generic · Class 3 | Lormetazepam InjectionCYHL2100017 | Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized |
| 2021/03/17New drug · Class 1 | 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101004 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2021/03/17New drug · Class 1 | 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101003 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2021/03/17New drug · Class 1 | ASC42片 · No verified English nameCXHL2101004 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/03/17New drug · Class 1 | ASC42片 · No verified English nameCXHL2101003 | Gan Lai Pharmaceutical Co., Ltd. romanized |
| 2021/03/16Generic · Class 3 | 氯化钾缓释片(I) · No verified English nameCYHS2100285 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/03/16Generic · Class 3 | Brexpiprazole TabletsCYHS2100283 | YaoPharma Co., Ltd. |
| 2021/03/16Generic · Class 3 | Brexpiprazole TabletsCYHS2100282 | YaoPharma Co., Ltd. |
| 2021/03/16Generic · Class 3 | Brexpiprazole TabletsCYHS2100281 | YaoPharma Co., Ltd. |
| 2021/03/16Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2100280 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
5 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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