YaoGeJu

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

Period
2021/02/18 to 2021/02/24, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement118
Generic42
New drug34
Import11
Import re-registration3
Unspecified1

By drug type

Drug typeFilings
Chemical drug155
Therapeutic biologic37
TCM9
Prophylactic biologic8

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Torsemide Injection321
2Palbociclib Capsules310
3Olanzapine Orally Disintegrating Tablets210
4Pregabalin Capsules2112
5Pemetrexed Disodium for Injection214
6Azithromycin For Injection2111
7Dexmedetomidine Hydrochloride Injection211
8Palonosetron Hydrochloride Injection211
9色甘酸钠颗粒 · No verified English name210
10丙酸氟替卡松吸入粉雾剂 · No verified English name111

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)FilingsDrugsGeneric
1Pfizer Europe MA EEIG730
2Xian Jing Xi Shuang He Pharma Co., Ltd. romanized620
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized531
4CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
5Hebei Tian Cheng Pharma Co., Ltd. romanized440
6Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized420
7Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized421
8Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized420
9Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized420
10GlaxoSmithKline Biologicals SA410

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

AcceptedDrugApplicants
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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