YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 166 drug applications between 17 March 2021 and 23 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 17, covering 11 drug names.
2021/03/17 – 2021/03/23
- New acceptances this week
- 166
- 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
166filings, 17 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 90 |
| Import | 24 |
| New drug | 23 |
| Generic | 17 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 134 |
| Therapeutic biologic | 25 |
| TCM | 2 |
| Biologic | 2 |
| Prophylactic 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 | Sodium Valproate Concentrated Solution for Injection | 3 | 1 | 0 |
| 2 | Argatroban Injection | 2 | 2 | 2 |
| 3 | Saxagliptin Tablets | 2 | 1 | 0 |
| 4 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 5 | Febuxostat Tablets | 2 | 1 | 12 |
| 6 | 头孢地尼颗粒 · No verified English name | 1 | 1 | 3 |
| 7 | Lormetazepam Injection | 1 | 1 | 0 |
| 8 | Palonosetron Hydrochloride Injection | 1 | 1 | 1 |
| 9 | Venlafaxine Hydrochloride Sustained-Release Capsules | 1 | 1 | 0 |
| 10 | Lanthanum Carbonate Chewable Tablets | 1 | 1 | 2 |
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
87 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 2 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 8 | 4 | 0 |
| 3 | Astrazeneca UK Limited | 6 | 1 | 0 |
| 4 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 5 | 2 | 3 |
| 5 | LABORATORIOS FARMACEUTICOS ROVI S.A. | 5 | 1 | 0 |
| 6 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 7 | Loxo Oncology Inc. | 4 | 1 | 0 |
| 8 | Mirum Pharmaceuticals Inc. | 4 | 1 | 0 |
| 9 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Novartis Pharma Schweiz AG | 3 | 2 | 0 |
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
40 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/03/23Import · Class 1 | 注射用LNA043 · No verified English nameJXSL2100043 | Novartis Pharma AG |
| 2021/03/23Generic · Class 3 | 头孢地尼颗粒 · No verified English nameCYHS2100289 | Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 3.3 | 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100102 | Hua Run Ang De Bio Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 3.3 | 重组人GLP-1-Fc融合蛋白注射液 · No verified English nameCXSL2100101 | Hua Run Ang De Bio Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 西格列他钠片 · No verified English nameCXHL2101009 | Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2100197 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2100196 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2100195 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | 希列克托灵片 · No verified English nameCXHL2100194 | Shenzhen Ming Sai Rui Lin Pharma Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | SYHX1903片 · No verified English nameCXHL2100193 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | SYHX1903片 · No verified English nameCXHL2100192 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/03/23New drug · Class 2.2; 2.4 | 乙酸避孕凝胶 · No verified English nameCXHL2100191 | Shanghai Shi Ji Hua Sheng Yu Ke Xue Research Institute romanized |
| 2021/03/23New drug · Class 1 | PA9159鼻喷雾剂 · No verified English nameCXHL2100187 | Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/23New drug · Class 1 | PA9159鼻喷雾剂 · No verified English nameCXHL2100186 | Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/03/22New drug · Class 1 | IBI302 · No verified English nameCXSL2101006 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 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 |
10 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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