YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 49 drug applications between 10 February 2021 and 16 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 4, covering 4 drug names.
2021/02/10 – 2021/02/16
- New acceptances this week
- 49
- Drugs with new generic filings (by drug name, de-duplicated)
- 4
- 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
49filings, 4 of them generic
By application type
| Application type | Filings |
|---|---|
| Import | 20 |
| Supplement | 16 |
| New drug | 7 |
| Generic | 4 |
| Drug-device combination product | 1 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 28 |
| Therapeutic biologic | 18 |
| TCM | 1 |
| Drug-device combination | 1 |
| Prophylactic biologic | 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
4 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vortioxetine Hydrobromide Tablets | 1 | 1 | 10 |
| 2 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
| 3 | Phenylephrine Hydrochloride Injection | 1 | 1 | 5 |
| 4 | Olopatadine Hydrochloride 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
33 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Ke Lun Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 2 | Allergan Pharmaceuticals Ireland | 3 | 1 | 0 |
| 3 | Merck Europe B.V. | 3 | 1 | 0 |
| 4 | Orion Corporation | 3 | 1 | 0 |
| 5 | Pfizer Inc. | 3 | 1 | 0 |
| 6 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 7 | AstraZeneca AB | 2 | 1 | 0 |
| 8 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Adimmune Corporation | 1 | 1 | 0 |
| 10 | Affibody AB | 1 | 1 | 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
23 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/11Import · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameJXSS2100009 | Adimmune Corporation |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2100025 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2100024 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2100023 | Allergan Pharmaceuticals Ireland |
| 2021/02/11Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2100022 | Affibody AB |
| 2021/02/11Import · Class 3.1 | 阿替利珠单抗注射液 · No verified English nameJXSL2100021 | F.Hoffmann-La Roche Ltd |
| 2021/02/11Import · Class 3.1 | Eptinezumab注射用浓溶液 · No verified English nameJXSL2100019 | Lundbeck |
| 2021/02/11Import · Class 1 | 阿布昔替尼片 · No verified English nameJXHS2100022 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | 阿布昔替尼片 · No verified English nameJXHS2100021 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | 阿布昔替尼片 · No verified English nameJXHS2100020 | Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH |
| 2021/02/11Import · Class 1 | Aramchol片 · No verified English nameJXHL2100052 | Galmed Research and Development Ltd. |
| 2021/02/11Import · Class 1 | AZD9833片 · No verified English nameJXHL2100051 | AstraZeneca AB |
| 2021/02/11Import · Class 1 | AZD9833片 · No verified English nameJXHL2100050 | AstraZeneca AB |
| 2021/02/11Import · Class 2.4 | 达罗他胺片 · No verified English nameJXHL2100049 | Bayer HealthCare Pharmaceuticals Inc. |
| 2021/02/11Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2100194 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2021/02/11New drug · Class 3.3 | 门冬胰岛素30注射液 · No verified English nameCXSS2100019 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2100018 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2100017 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2100016 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/11New drug · Class 1 | 注射用间充质干细胞(脐带) · No verified English nameCXSL2100056 | Tianjin Ang Sai Xi Bao Ji Yin Gong Cheng Co., Ltd. romanized |
| 2021/02/11New drug · Class 2.4 | BAT4706注射液 · No verified English nameCXSL2100050 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/02/11New drug · Class 2.4 | BAT4706注射液 · No verified English nameCXSL2100049 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/02/10Import · Class 1 | Pamrevlumab · No verified English nameJXSL2100020 | FibroGen Inc |
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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