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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 11 December 2021 and 17 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.

2021/12/11 – 2021/12/17

Period
2021/12/11 to 2021/12/17, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
38
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

390filings, 51 of them generic

By application type

Application typeFilings
Supplement231
New drug75
Generic51
Import re-registration12
Import11
Unspecified10

By drug type

Drug typeFilings
Chemical drug290
TCM57
Therapeutic biologic39
Prophylactic biologic4

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Guanfacine Hydrochloride Extended Release Tablets414
2盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
3Ambroxol Hydrochloride Solution For Inhalation2210
4Vildagliptin Tablets220
5Nintedanib Esilate Soft Capsules216
6Eplerenone Tablets214
7Ipratropium Bromide Inhalation Solution212
8Sildenafil Citrate Tablets2112
9Nafamostat Mesilate for Injection2138
10Febuxostat Tablets2112

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

167 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized67570
2Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized32250
3Zhengzhou Yu Gang Zhi Xing Pharmaceutical Co., Ltd. romanized1090
4Haerbin Tian Mei Pharma Co., Ltd. romanized1060
5Yi Chang Ren Fu Pharma Co., Ltd. romanized735
6Guizhou Liang Ji Pharma Co., Ltd. romanized660
7Heilongjiang Kui Hua Pharma Co., Ltd. romanized650
8Janssen-Cilag International NV610
9Eli Lilly and Company520
10Hainan Yi Er Pharma Co., Ltd. romanized430

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

101 this week

AcceptedDrugApplicants
2021/12/17Import · Class 1 注射用TNP-2092 · No verified English nameJXHL2101269 TenNor Therapeutics Limited; TenNor (Suzhou) Therapeutics Limited
2021/12/17Generic · Class 3 Methotrexate For InjectionCYHS2102209 Shanghai Shang Yao Rui Er Medicines Co., Ltd. romanized; Shanghai Pharmaceuticals Group (Ben Xi) Bei Fang Pharma Co., Ltd. romanized
2021/12/17Generic · Class 3 Eplerenone TabletsCYHS2102151 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized
2021/12/17Generic · Class 3 Eplerenone TabletsCYHS2102150 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized
2021/12/17New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101491 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/12/17New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101490 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/12/17New drug · Class 1 人iPSC来源心肌细胞注射液 · No verified English nameCXSL2101489 Nanjing Ai Er Pu Zai Sheng Yi Xue Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 重组抗HER2结构域Ⅱ和结构域Ⅳ双特异性抗体注射液 · No verified English nameCXSL2101488 Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 YH001注射液 · No verified English nameCXSL2101481 Name not romanized
2021/12/17New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHS2101055 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Li Si Biopharmaceuticals Co., Ltd. romanized
2021/12/17New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2101785 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2101784 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 ABSK061胶囊 · No verified English nameCXHL2101783 Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 LZ001片 · No verified English nameCXHL2101782 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2021/12/17New drug · Class 1 LZ001片 · No verified English nameCXHL2101781 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2021/12/17New drug · Class 1 LW231片 · No verified English nameCXHL2101778 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2021/12/17New drug · Class 1 LW231片 · No verified English nameCXHL2101777 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2021/12/17New drug · Class 1 LW231片 · No verified English nameCXHL2101776 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2021/12/17New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2101775 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2101774 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2021/12/17New drug · Class 2.3 BCM340缓释片 · No verified English nameCXHL2101773 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/12/17New drug · Class 2.3 BCM340缓释片 · No verified English nameCXHL2101772 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/12/17New drug · Class 2.3 BCM340缓释片 · No verified English nameCXHL2101771 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2021/12/17New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101770 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/17New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101769 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/17New drug · Class 1 HTMC0435片 · No verified English nameCXHL2101768 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/12/17New drug · Class 1 HRS-2261片 · No verified English nameCXHL2101754 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/12/17New drug · Class 1 HRS-2261片 · No verified English nameCXHL2101752 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/12/16Import · Class 1 甲磺酸氢甲硫堇(LMTM)片 · No verified English nameJXHL2101273 TauRx Therapeutics Ltd.; dMed Biopharmaceutical Co. Ltd.
2021/12/16Import · Class 1 AZD8233注射液 · No verified English nameJXHL2101272 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

71 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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