YaoGeJu

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

Period
2021/02/17 to 2021/02/23, 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
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 typeFilings
Supplement103
New drug28
Generic26
Import10
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug124
Therapeutic biologic31
TCM8
Prophylactic biologic7

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Pemetrexed Disodium for Injection214
3Azithromycin For Injection2111
4Palonosetron Hydrochloride Injection211
5Etoricoxib Tablets118
6吸入用七氟烷 · No verified English name110
7Ceritinib Capsules111
8Ornidazole Injection110
9Brivaracetam Solution for Injection110
10Estradiol Valerate Tablets117

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)FilingsDrugsGeneric
1Pfizer Europe MA EEIG620
2Xian Jing Xi Shuang He Pharma Co., Ltd. romanized620
3Hebei Tian Cheng Pharma Co., Ltd. romanized440
4Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized420
5Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized421
6Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized420
7Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized420
8GlaxoSmithKline Biologicals SA410
9Zhejiang Yong Ning Pharma Co., Ltd. romanized410
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized321

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

AcceptedDrugApplicants
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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