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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 208 drug applications between 13 November 2021 and 19 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 31 drug names.

2021/11/13 – 2021/11/19

Period
2021/11/13 to 2021/11/19, 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
208
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

208filings, 44 of them generic

By application type

Application typeFilings
Supplement98
Generic44
New drug29
Import18
Import re-registration14
Unspecified5

By drug type

Drug typeFilings
Chemical drug166
TCM21
Therapeutic biologic17
Biologic2
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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name313
2Sildenafil Citrate Oral Disintegrating Tablets228
3Sodium Valproate Concentrated Solution for Injection210
4Ozagrel Sodium Injection213
5Obeticholic Acid Tablets210
6Vonoprazan Fumarate Tablets2160
7Bisoprolol Fumarate Tablets216
8Tolvaptan Tablets210
9Pregabalin Capsules2112
10Tandospirone Citrate Tablets212

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

122 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Da Lian Tian Shan Pharma Co., Ltd. romanized660
2Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized660
3Upjohn Manufacturing Ireland Unlimited610
4Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized440
5Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized420
6Fujian Sheng Fu Kang Pharma Co., Ltd. romanized420
7Sanofi-aventis groupe410
8Upjohn US 2 LLC410
9Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized410
10Guangxi Ge Hong Tang Fang Lve Pharmaceutical Co., Ltd. romanized330

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

53 this week

AcceptedDrugApplicants
2021/11/19Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2102028 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/11/19New drug · Class 3.2 人抗凝血酶Ⅲ · No verified English nameCXSS2101053 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2021/11/19New drug · Class 1 泰特利单抗注射液 · No verified English nameCXSS2101052 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/11/19New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101427 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/19New drug · Class 1 FZJ-003胶囊 · No verified English nameCXHL2101675 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2021/11/19New drug · Class 1 BPI-442096片 · No verified English nameCXHL2101669 Bei Da Pharma Co., Ltd. romanized
2021/11/19New drug · Class 1 BPI-442096片 · No verified English nameCXHL2101668 Bei Da Pharma Co., Ltd. romanized
2021/11/19New drug · Class 1 HS301片 · No verified English nameCXHL2101667 Han Hui Pharmaceutical Co., Ltd. romanized
2021/11/19New drug · Class 1 HS301片 · No verified English nameCXHL2101666 Han Hui Pharmaceutical Co., Ltd. romanized
2021/11/18Import · Class 1 司柏索利单抗注射液 · No verified English nameJXSS2101030 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/18Import · Class 1 注射用Dapirolizumab Pegol单抗 · No verified English nameJXSL2101134 UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd
2021/11/18Generic · Class 3 Aminophylline InjectionCYHS2102047 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized
2021/11/18Generic · Class 3 Aminophylline InjectionCYHS2102046 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized
2021/11/18Generic · Class 3 Furosemide InjectionCYHS2102045 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2021/11/18New drug · Class 2.4 Flutemetamol (18F) 注射液 · No verified English nameCXHL2101674 Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized
2021/11/17Import · Class 1 elranatamab · No verified English nameJXSL2101133 Pfizer Inc; Pfizer Investment CO. Ltd.
2021/11/17Import · Class 3.1 甘精胰岛素利司那肽注射液2:1 · No verified English nameJXSL2101132 Sanofi-Aventis Groupe; Sanofi (China) Investment Co. Ltd.
2021/11/17Import · Class 3.1 甘精胰岛素利司那肽注射液1:1 · No verified English nameJXSL2101131 Sanofi K. K.; Sanofi (China) Investment Co. Ltd.
2021/11/17Import · Class 1 注射用Bempegaldesleukin · No verified English nameJXSL2101129 Nektar Therapeutics; PPD Pharmaceutical Development (Beijing) Co. Ltd
2021/11/17Import · Class 1 注射用Bempegaldesleukin · No verified English nameJXSL2101128 Nektar Therapeutics; PPD Pharmaceutical Development (Beijing) Co. Ltd
2021/11/17Import · Class 2.4 Empagliflozin TabletsJXHS2101074 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/11/17Import · Class 1 CK-3773274片 · No verified English nameJXHL2101242 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2021/11/17New drug · Class 2.4 Remimazolam Besylate For InjectionCXHS2101053 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/11/17New drug · Class 1 TQH3821片 · No verified English nameCXHL2101673 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/11/17New drug · Class 1 TQH3821片 · No verified English nameCXHL2101672 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/11/17New drug · Class 1 GD-N1702胶囊 · No verified English nameCXHL2101671 Hao Yi Sheng Pharma Group Co., Ltd. romanized
2021/11/17New drug · Class 1 GD-N1702胶囊 · No verified English nameCXHL2101670 Hao Yi Sheng Pharma Group Co., Ltd. romanized
2021/11/16Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSL2101130 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102031 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2021/11/16Generic · Class 3 Ozagrel Sodium InjectionCYHS2102030 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized

23 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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