YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 314 drug applications between 8 December 2021 and 14 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.

2021/12/08 – 2021/12/14

Period
2021/12/08 to 2021/12/14, 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
314
Drugs with new generic filings (by drug name, de-duplicated)
37
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

314filings, 49 of them generic

By application type

Application typeFilings
Supplement186
New drug51
Generic49
Import14
Import re-registration10
Unspecified4

By drug type

Drug typeFilings
Chemical drug218
TCM49
Therapeutic biologic44
Prophylactic biologic3

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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Guanfacine Hydrochloride Extended Release Tablets414
2阿普米司特片 · No verified English name313
3Tofacitinib Citrate Tablets221
4Vildagliptin Tablets220
5Candesartan Cilexetil and Hydrochlorothiazide Tablets210
6Sildenafil Citrate Tablets2112
7Valsartan Film-Coated Tablets210
8Carbocisteine Oral Solution216
9Febuxostat Tablets2112
10Clotrimazole Vaginal Tablets113

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

159 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized22200
2Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized11110
3Haerbin Tian Mei Pharma Co., Ltd. romanized1060
4Yi Chang Ren Fu Pharma Co., Ltd. romanized945
5Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized860
6Janssen-Cilag International NV820
7medac Gesellschaft für klinische Spezialpr?parate mbH810
8Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
9Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized550
10Ha Yao Group Zhong Yao Er Factory romanized540

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

71 this week

AcceptedDrugApplicants
2021/12/14Import · Class 1 DS-1062a · No verified English nameJXSL2101147 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/12/14Import · Class 1 盐酸PQ912片 · No verified English nameJXHL2101271 Vivoryon Therapeutics N.V.; Jiangsu Simcere Pharmaceutical Co. Ltd.
2021/12/14Import · Class 1 盐酸PQ912片 · No verified English nameJXHL2101270 Vivoryon Therapeutics N.V.; Jiangsu Simcere Pharmaceutical Co. Ltd.
2021/12/14Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2102197 Jilin Sheng Li Hua Pharmaceutical Co., Ltd. romanized
2021/12/14Generic · Class 3 Bepotastine Besilate Orally Disintegrating TabletsCYHS2102189 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Bei De Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101055 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101054 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101053 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101052 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Desonide CreamCYHL2101051 Fu Yuan Pharma Co., Ltd. romanized
2021/12/14Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2101048 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized
2021/12/14New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2101058 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/14New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSS2101057 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/14New drug · Class 1 HBM9378(SKB378) 注射液 · No verified English nameCXSL2101485 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/12/14New drug · Class 1 注射用IMM01 · No verified English nameCXSL2101484 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/12/14New drug · Class 1 Zilovertamab vedotin注射液 · No verified English nameCXSL2101483 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2021/12/14New drug · Class 1 QL1706注射液 · No verified English nameCXSL2101480 Qilu Pharmaceutical Co., Ltd.
2021/12/14New drug · Class 1 YH003注射液 · No verified English nameCXSL2101479 Name not romanized
2021/12/14New drug · Class 1 FKC889 · No verified English nameCXSL2101478 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2021/12/14New drug · Class 1 AK104注射液 · No verified English nameCXSL2101476 Kang Fang Pharma Co., Ltd. romanized
2021/12/14New drug · Class 2.2; 2.4 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHL2101755 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14New drug · Class 2.2 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHL2101753 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/12/14New drug · Class 1 TQH3910片 · No verified English nameCXHL2101751 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/12/14New drug · Class 1 TQH3910片 · No verified English nameCXHL2101750 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/12/14New drug · Class 1 HL-085胶囊 · No verified English nameCXHL2101747 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2021/12/14New drug · Class 1 HL-085胶囊 · No verified English nameCXHL2101746 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2021/12/14New drug · Class 1 HL-085胶囊 · No verified English nameCXHL2101745 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2021/12/14New drug · Class 1 HL-085胶囊 · No verified English nameCXHL2101744 Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized
2021/12/14New drug · Class 1 ORIN1001片 · No verified English nameCXHL2101743 Fu Xing Hong Chuang (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized
2021/12/14New drug · Class 1 HS-10370片 · No verified English nameCXHL2101738 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized

41 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.