YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 170 drug applications between 17 February 2021 and 23 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 21 drug names.
2021/02/17 – 2021/02/23
- New acceptances this week
- 170
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- 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
170filings, 26 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 103 |
| New drug | 28 |
| Generic | 26 |
| Import | 10 |
| Import re-registration | 2 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 124 |
| Therapeutic biologic | 31 |
| TCM | 8 |
| Prophylactic biologic | 7 |
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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 3 | Azithromycin For Injection | 2 | 1 | 11 |
| 4 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 5 | Etoricoxib Tablets | 1 | 1 | 8 |
| 6 | 吸入用七氟烷 · No verified English name | 1 | 1 | 0 |
| 7 | Ceritinib Capsules | 1 | 1 | 1 |
| 8 | Ornidazole Injection | 1 | 1 | 0 |
| 9 | Brivaracetam Solution for Injection | 1 | 1 | 0 |
| 10 | Estradiol Valerate Tablets | 1 | 1 | 7 |
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
101 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Europe MA EEIG | 6 | 2 | 0 |
| 2 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Hebei Tian Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 4 | 2 | 1 |
| 6 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | GlaxoSmithKline Biologicals SA | 4 | 1 | 0 |
| 9 | Zhejiang Yong Ning Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 3 | 2 | 1 |
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
38 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/23Import · Class 1 | Pamrevlumab · No verified English nameJXSL2100030 | FibroGen Inc |
| 2021/02/23Generic · Class 3 | Ornidazole InjectionCYHS2100220 | Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | TQC2731注射液 · No verified English nameCXSL2100065 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | 重组人源化单克隆抗体MIL162注射液 · No verified English nameCXSL2100062 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | FHND6091胶囊 · No verified English nameCXHL2100132 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | FHND6091胶囊 · No verified English nameCXHL2100131 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | HW021199片 · No verified English nameCXHL2100130 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2021/02/23New drug · Class 1 | HW021199片 · No verified English nameCXHL2100129 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2021/02/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2100128 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/02/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2100127 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/02/23New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2100126 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/02/23New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2100125 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2021/02/23New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2100124 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2021/02/22New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2100061 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/02/22New drug · Class 1 | AP-L1898胶囊 · No verified English nameCXHL2100123 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/22New drug · Class 1 | AP-L1898胶囊 · No verified English nameCXHL2100122 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/21Generic · Class 3 | Doxepin Hydrochloride TabletsCYHS2100214 | Shenyang Hua Tai Drug Research Co., Ltd. romanized; Shenyang Fu Ning Pharma Co., Ltd. romanized |
| 2021/02/21Generic · Class 3 | Brivaracetam Solution for InjectionCYHS2100213 | Yang Zi Jiang Pharma Group Sichuan Hai Rong Pharma Co., Ltd. romanized |
| 2021/02/21New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100120 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/21New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100119 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/21New drug · Class 1 | JMKX000189片 · No verified English nameCXHL2100118 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/21New drug · Class 1 | FM888胶囊 · No verified English nameCXHL2100117 | Qingdao Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/21New drug · Class 1 | FM888胶囊 · No verified English nameCXHL2100116 | Qingdao Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/20Import · Class 1 | Belzutifan片 · No verified English nameJXHL2100053 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. |
| 2021/02/20New drug · Class 1 | 9MW1911注射液 · No verified English nameCXSL2100060 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/02/20New drug · Class 1 | QL1779注射液 · No verified English nameCXSL2100059 | Qilu Pharmaceutical Co., Ltd. |
| 2021/02/20New drug · Class 1 | 9MW1911注射液 · No verified English nameCXSL2100058 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/02/20New drug · Class 2.4 | Lenvatinib Mesilate CapsulesCXHL2100115 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/02/20New drug · Class 1 | 注射用BXOS110 · No verified English nameCXHL2100113 | Bai Xi Ou Si (Beijing) Bio Technology Co., Ltd. romanized |
| 2021/02/19Import · Class 3.1 | 达雷妥尤单抗注射液 · No verified English nameJXSS2100016 | Janssen-Cilag International NV; Cilag AG |
8 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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