YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 270 drug applications between 3 February 2021 and 9 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 40 drug names.
2021/02/03 – 2021/02/09
- New acceptances this week
- 270
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- Accepted this week, now under review
- 3
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
270filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 101 |
| New drug | 56 |
| Generic | 53 |
| Import | 36 |
| Unspecified | 12 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 217 |
| Therapeutic biologic | 36 |
| TCM | 13 |
| Biologic | 3 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 2 | 阿普斯特片 · No verified English name | 3 | 1 | 0 |
| 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 2 | 2 |
| 4 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
| 5 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 6 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 7 | Tirofiban Hydrochloride And Sodium Chloride Injection | 2 | 1 | 2 |
| 8 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 9 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 10 | 莫米松福莫特罗吸入气雾剂 · No verified English name | 2 | 1 | 0 |
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
169 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 5 | 3 | 0 |
| 2 | Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized | 5 | 1 | 0 |
| 3 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 4 | AbbVie Inc. | 4 | 2 | 0 |
| 5 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 6 | Yangtze River Pharmaceutical Group Co., Ltd | 4 | 2 | 2 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Henan Ke Lun Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 2 | 4 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 3 | 3 | 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
106 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/09Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100048 | Zentera Therapeutics HK Limited |
| 2021/02/09Import · Class 1 | ZN-c3片 · No verified English nameJXHL2100047 | Zentera Therapeutics HK Limited |
| 2021/02/09Import · Class 1 | MK-8189 · No verified English nameJXHL2100046 | Merck Sharp & Dohme International GmbH |
| 2021/02/09Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHS2100190 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2021/02/09Generic · Class 3 | Levofloxacin InjectionCYHS2100189 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/02/09Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2100187 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2021/02/09Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2100186 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2021/02/09Generic · Class 3 | 阿普斯特片 · No verified English nameCYHS2100185 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2021/02/09Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2100179 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/02/09Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2100178 | Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/02/09Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2100177 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/02/09New drug · Class 1 | T3011疱疹病毒注射液 · No verified English nameCXSL2100055 | Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | BGB-A1217注射液 · No verified English nameCXSL2100054 | Bai Ji Shen Zhou (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2100053 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | 靶向间皮素嵌合抗原受体NK细胞注射液 · No verified English nameCXSL2100052 | Guo Jian Cheng Nuo Bio Technology (Beijing) Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2100051 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2100004 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | 注射用BGC0228 · No verified English nameCXHL2100112 | Bo Rui Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | SY-4835片 · No verified English nameCXHL2100111 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | SY-4835片 · No verified English nameCXHL2100110 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | SY-4835片 · No verified English nameCXHL2100109 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | Vilazodone Hydrochloride TabletsCXHL2100106 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | Vilazodone Hydrochloride TabletsCXHL2100105 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | Vilazodone Hydrochloride TabletsCXHL2100104 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | KL210122片 · No verified English nameCXHL2100103 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | KL210122片 · No verified English nameCXHL2100102 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/09New drug · Class 1 | KL210122片 · No verified English nameCXHL2100101 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/09New drug · Class 2.2 | HR20005凝胶 · No verified English nameCXHL2100100 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/02/08Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100014 | Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG |
| 2021/02/08Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSS2100013 | Ferring Pharmaceuticals A/S; Vetter Pharma-Fertigung GmbH & Co.KG |
76 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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