YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 179 drug applications between 28 March 2021 and 3 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 12 drug names.
2021/03/28 – 2021/04/03
- New acceptances this week
- 179
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- 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
179filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 99 |
| New drug | 25 |
| Generic | 20 |
| Import | 18 |
| Import re-registration | 13 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 132 |
| Therapeutic biologic | 34 |
| TCM | 6 |
| Prophylactic biologic | 6 |
| 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
12 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Memantine Hydrochloride Tablets | 4 | 1 | 2 |
| 2 | Olanzapine Tablets | 2 | 1 | 4 |
| 3 | Levofloxacin Tablets | 2 | 1 | 7 |
| 4 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 5 | Metoprolol Tartrate Tablets | 2 | 1 | 3 |
| 6 | Ranolazine Prolonged-Release Tablets | 2 | 1 | 3 |
| 7 | 丙泊酚乳状注射液 · No verified English name | 1 | 1 | 3 |
| 8 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 9 | Torsemide Injection | 1 | 1 | 1 |
| 10 | Glycopyrronium Bromide and Neostigmine Metilsulfate Injection | 1 | 1 | 3 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 2 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 3 | Bao Ding Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Novartis Pharma AG | 4 | 3 | 0 |
| 6 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 7 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 1 | 0 |
| 9 | Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Tong Fang Pharma Group Co., Ltd. romanized | 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
45 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/03New drug · Class 1.1 | 六合丹软膏 · No verified English nameCXZL2100003 | Sichuan University Hua Xi Hospital romanized |
| 2021/04/03New drug · Class 1 | 注射用重组人源化抗Muc1单抗-Tub201偶联剂 · No verified English nameCXSL2100114 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2021/04/03New drug · Class 3.3 | 流感病毒裂解疫苗 · No verified English nameCXSL2100113 | Shanxi Pei Sen Bio Technology Co., Ltd. romanized |
| 2021/04/03New drug · Class 2.2 | 阿地溴铵吸入粉雾剂 · No verified English nameCXHL2100218 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/04/02Import · Class 3.3 | 注射用英夫利西单抗 · No verified English nameJXSS2100022 | CELLTRION Inc. |
| 2021/04/02Import · Class 1 | 注射用阿帕拉格鲁肽 · No verified English nameJXHL2100112 | VectivBio AG |
| 2021/04/02Generic · Class 3 | Torsemide InjectionCYHS2100309 | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/02Generic · Class 3 | Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2100018 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2021/04/02New drug · Class 1.1 | 川芎定痛颗粒 · No verified English nameCXZL2100004 | Beijing Yang Guang He He Zhong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/04/02New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2100112 | Jilin Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2021/04/02New drug · Class 1 | LM-102 注射液 · No verified English nameCXSL2100111 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2021/04/02New drug · Class 1 | HS-10374片 · No verified English nameCXHL2100217 | Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2021/04/02New drug · Class 1 | HS-10374片 · No verified English nameCXHL2100216 | Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2021/04/02New drug · Class 1 | PG-011凝胶 · No verified English nameCXHL2100215 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/02New drug · Class 1 | PG-011凝胶 · No verified English nameCXHL2100214 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/01Import · Class 3.1 | 贝伐珠单抗注射液 · No verified English nameJXSS2100021 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2021/04/01Import · Class 1 | Teclistamab 注射液 · No verified English nameJXSL2101003 | Janssen Research & Development LLC; Johnson & Jonson （China）Investment Ltd. |
| 2021/04/01Import · Class 1 | Teclistamab 注射液 · No verified English nameJXSL2101002 | Janssen Research & Development， LLC; Johnson & Johnson （China）Investment Ltd |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegol · No verified English nameJXSL2100050 | Novo Nordisk A/S |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegol · No verified English nameJXSL2100049 | Novo Nordisk A/S |
| 2021/04/01Import · Class 3.1 | Nonacog beta pegol · No verified English nameJXSL2100048 | Novo Nordisk A/S |
| 2021/04/01Import · Class 1 | 注射用LNA043 · No verified English nameJXSL2100047 | Novartis Pharma AG |
| 2021/04/01Import · Class 2.2 | ACZ885注射液 · No verified English nameJXSL2100046 | Novartis Pharma AG |
| 2021/04/01Import · Class 2.4 | 注射用Trilaciclib · No verified English nameJXHL2100110 | G1 THERAPEUTICS INC. |
| 2021/04/01Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHL2100020 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/01Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHL2100019 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/01New drug · Class 1.1 | 小儿连花清感颗粒 · No verified English nameCXZL2101003 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2021/04/01New drug · Class 2.3 | 痰热清胶囊 · No verified English nameCXZL2101002 | Shanghai Kai Bao Pharma Co., Ltd. romanized |
| 2021/04/01New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2101008 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2021/04/01New drug · Class 1 | JS007注射液 · No verified English nameCXSL2100110 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
15 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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