YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 203 drug applications between 25 July 2021 and 31 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 21 drug names.

2021/07/25 – 2021/07/31

Period
2021/07/25 to 2021/07/31, 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
203
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

203filings, 26 of them generic

By application type

Application typeFilings
Supplement96
New drug39
Import27
Generic26
Unspecified9
Import re-registration6

By drug type

Drug typeFilings
Chemical drug138
Therapeutic biologic37
TCM25
Biologic2
Prophylactic biologic1

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
1Empagliflozin Tablets2118
2Pregabalin Capsules2112
3Micafungin Sodium for Injection210
4Caspofungin Acetate for Injection218
5Dapagliflozin Tablets2184
6Enoxaparin Sodium Injection1116
7Limaprost Alfadex Tablets110
8Carbetocin Injection116
9Doxofylline Injection115
10Tenofovir alafenamide Fumarate Tablets110

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized732
2Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized550
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.442
5Janssen-Cilag International NV430
6Merck Sharp & Dohme Corp.320
7San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized320
8Rui Yang Pharmaceutical Co., Ltd. romanized320
9Bristol-Myers Squibb Pharma EEIG310
10Pfizer Europe MA EEIG310

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

63 this week

AcceptedDrugApplicants
2021/07/30Import · Class 1 Rilzabrutinib · No verified English nameJXHL2101147 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2021/07/30Generic · Class 3 Clofarabine InjectionCYHS2101502 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2021/07/30New drug · Class 1.1 芪红固本颗粒 · No verified English nameCXZL2101021 Guangzhou Ru Yuan Bio Technology Co., Ltd. romanized
2021/07/30New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2101015 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/30New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2101014 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/07/30New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101226 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/30New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2101224 Hua Xia Yuan Xi Bao Gong Cheng Group Co., Ltd. romanized
2021/07/30New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101347 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/07/30New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101346 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/07/30New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101345 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/07/30New drug · Class 1 NB005胶囊 · No verified English nameCXHL2101344 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/30New drug · Class 1 NB005胶囊 · No verified English nameCXHL2101343 Ningbo Xin Wan Technology Development Co., Ltd. romanized
2021/07/29Import · Class 1 TJ107注射液 · No verified English nameJXSL2101083 I-MAB Biopharma US Limited; I-MAB Biopharma Co. Ltd.
2021/07/29Import · Class 1 Bermekimab注射液 · No verified English nameJXSL2101082 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/07/29Import · Class 1 DS-1062a · No verified English nameJXSL2101081 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2021/07/29Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101495 Hangzhou Yuan Su Pharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2021/07/29Generic · Class 3 布洛芬混悬滴剂 · No verified English nameCYHS2101494 Beijing Bai Ao Pharma Co., Ltd. romanized; Jilin Yi Min Tang Pharmaceutical Co., Ltd. romanized
2021/07/29Generic · Class 3 Magnesium Sulfate InjectionCYHS2101489 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/07/29New drug · Class 2.2 注射用伊尼妥单抗 · No verified English nameCXSL2101223 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/29New drug · Class 1 PB-201片 · No verified English nameCXHL2101333 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/07/29New drug · Class 1 PB-201片 · No verified English nameCXHL2101332 Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/07/28Import · Class 1 MK-4280A注射液 · No verified English nameJXSL2101080 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/07/28Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101144 Eisai Europe Ltd.
2021/07/28Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101143 Eisai Europe Ltd.
2021/07/28Generic · Class 3 Citicoline Sodium InjectionCYHS2101492 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/07/28New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101221 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/28New drug · Class 1 注射用QLF32004 · No verified English nameCXSL2101220 Qilu Pharmaceutical Co., Ltd.
2021/07/28New drug · Class 1 HS-10375片 · No verified English nameCXHL2101340 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 HS-10375片 · No verified English nameCXHL2101339 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 ICP-189片 · No verified English nameCXHL2101338 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized

33 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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