YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 209 drug applications between 18 February 2021 and 24 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 31 drug names.
2021/02/18 – 2021/02/24
- New acceptances this week
- 209
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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
209filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 118 |
| Generic | 42 |
| New drug | 34 |
| Import | 11 |
| Import re-registration | 3 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 155 |
| Therapeutic biologic | 37 |
| TCM | 9 |
| Prophylactic biologic | 8 |
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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Torsemide Injection | 3 | 2 | 1 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | Olanzapine Orally Disintegrating Tablets | 2 | 1 | 0 |
| 4 | Pregabalin Capsules | 2 | 1 | 12 |
| 5 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 6 | Azithromycin For Injection | 2 | 1 | 11 |
| 7 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 9 | 色甘酸钠颗粒 · No verified English name | 2 | 1 | 0 |
| 10 | 丙酸氟替卡松吸入粉雾剂 · No verified English name | 1 | 1 | 1 |
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
124 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Pfizer Europe MA EEIG | 7 | 3 | 0 |
| 2 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 1 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 5 | Hebei Tian Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 4 | 2 | 1 |
| 8 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | GlaxoSmithKline Biologicals SA | 4 | 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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/24Import · Class 3.1 | 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSS2100019 | Pfizer Europe MA EEIG; Pfizer Ireland Pharmaceuticals |
| 2021/02/24Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2100237 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/02/24Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2100236 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/02/24Generic · Class 3 | Entecavir oral solutionCYHS2100235 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized; Bei Ke Nuo Dun (Zhejiang) Pharmaceutical Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | Torsemide InjectionCYHS2100233 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | Torsemide InjectionCYHS2100232 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | 色甘酸钠颗粒 · No verified English nameCYHS2100229 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | 色甘酸钠颗粒 · No verified English nameCYHS2100228 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | Torsemide InjectionCYHS2100227 | Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | Furosemide InjectionCYHS2100223 | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2021/02/24Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHL2100013 | Run Sheng Pharma Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | JS201注射液 · No verified English nameCXSL2100068 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | 重组人γ-干扰素腺病毒注射液 · No verified English nameCXSL2100067 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | LBL-003注射液 · No verified English nameCXSL2100066 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | HG146胶囊 · No verified English nameCXHL2100134 | Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | HG146胶囊 · No verified English nameCXHL2100133 | Chengdu Xian Dao Drug Kai Fa Co., Ltd. romanized |
| 2021/02/24New drug · Class 1 | HJ891胶囊 · No verified English nameCXHL2100121 | Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized |
| 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 |
25 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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