YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 128 drug applications between 16 April 2021 and 22 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 17, covering 12 drug names.

2021/04/16 – 2021/04/22

Period
2021/04/16 to 2021/04/22, 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
128
Drugs with new generic filings (by drug name, de-duplicated)
12
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

128filings, 17 of them generic

By application type

Application typeFilings
Supplement57
New drug27
Generic17
Import re-registration16
Import9
Unspecified2

By drug type

Drug typeFilings
Chemical drug104
Therapeutic biologic17
TCM5
Prophylactic biologic2

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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Afatinib Dimaleate Tablets322
2Pregabalin Capsules2112
3Ticagrelor Tablets2110
4Cabozantinib Tablets210
5Doxofylline Injection115
6布比卡因脂质体注射液 · No verified English name117
7Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution1123
8Parecoxib Sodium for Injection112
9Regorafenib Tablets113
10Fluoxetine Hydrochloride Dispersible 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

63 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qi Lu An Ti Pharmaceutical Co., Ltd. romanized1370
2Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized980
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized741
4Boehringer Ingelheim International GmbH620
5Ling Ke Pharma (Hangzhou) Co., Ltd. romanized420
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
7AstraZeneca AB410
8Lilly France410
9Yangtze River Pharmaceutical Group Co., Ltd331
10Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanized310

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

36 this week

AcceptedDrugApplicants
2021/04/21Import · Class 3.1 曲妥珠单抗注射液(皮下注射) · No verified English nameJXSS2101004 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/04/21Import · Class 2.4 Encorafenib硬胶囊 · No verified English nameJXHL2101010 Pierre Fabre Medicament; Covance Pharmaceutical Research and Development(Beijing)Co. Ltd.
2021/04/21Generic · Class 3 Cabozantinib TabletsCYHS2101082 Xian Sheng Pharma Co., Ltd. romanized
2021/04/21Generic · Class 3 Cabozantinib TabletsCYHS2101081 Xian Sheng Pharma Co., Ltd. romanized
2021/04/21New drug · Class 1 注射用FDA018抗体偶联剂 · No verified English nameCXSL2101031 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/04/21New drug · Class 3.3 CMAB820注射液 · No verified English nameCXSL2101030 Shanghai Zhang Jiang Bio Technology Co., Ltd. romanized
2021/04/21New drug · Class 3.3 重组抗VEGF人源化单克隆抗体Fab片段注射液 · No verified English nameCXSL2101029 Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized
2021/04/21New drug · Class 1 LVGN7409单克隆抗体注射液 · No verified English nameCXSL2101028 Li Jin Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/04/21New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101053 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/04/21New drug · Class 1 LNK01001胶囊 · No verified English nameCXHL2101052 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/04/21New drug · Class 1 SR419胶囊 · No verified English nameCXHL2101051 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2021/04/21New drug · Class 1 SR419胶囊 · No verified English nameCXHL2101050 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2021/04/21New drug · Class 1 TQB3824片 · No verified English nameCXHL2101049 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/21New drug · Class 1 TQB3824片 · No verified English nameCXHL2101048 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/21New drug · Class 1 LNK01003片 · No verified English nameCXHL2101047 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/04/21New drug · Class 1 LNK01003片 · No verified English nameCXHL2101046 Ling Ke Pharma (Hangzhou) Co., Ltd. romanized
2021/04/19Import · Class 1 BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101011 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/04/19Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2101011 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/04/19Import · Class 2.2; 2.4 盐酸二甲双胍迟释片 · No verified English nameJXHL2101009 Anji Pharma (US) LLC; Anji Pharma (Shanghai) Limited
2021/04/19New drug · Class 1 BR101注射液 · No verified English nameCXSL2101026 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2021/04/19New drug · Class 1 SHR7280片 · No verified English nameCXHL2101045 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/19New drug · Class 1 SHR7280片 · No verified English nameCXHL2101044 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/19New drug · Class 1 ICP-033片 · No verified English nameCXHL2101043 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/04/19New drug · Class 1 ICP-033片 · No verified English nameCXHL2101042 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/04/19New drug · Class 1 TQB3820片 · No verified English nameCXHL2101040 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/19New drug · Class 1 TQB3820片 · No verified English nameCXHL2101039 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/16Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101069 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2021/04/16Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2101068 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/16New drug · Class 1.1 芪连降糖片 · No verified English nameCXZL2101006 Shou Du Yi Ke University Fu Shu Beijing Shi Ji Tan Hospital romanized
2021/04/16New drug · Class 2.3 散风通窍滴丸 · No verified English nameCXZL2101005 Yangtze River Pharmaceutical Group Co., Ltd

6 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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