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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 9 December 2021 and 15 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.

2021/12/09 – 2021/12/15

Period
2021/12/09 to 2021/12/15, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
35
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

351filings, 44 of them generic

By application type

Application typeFilings
Supplement236
Generic44
New drug42
Import17
Import re-registration8
Unspecified4

By drug type

Drug typeFilings
Chemical drug236
TCM68
Therapeutic biologic43
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

35 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
3Vildagliptin Tablets220
4Sildenafil Citrate Tablets2112
5Carbocisteine Oral Solution216
6Febuxostat Tablets2112
7Clotrimazole Vaginal Tablets113
8Ambroxol Hydrochloride Solution For Inhalation1110
9Diquafosol Sodium Eye Drops115
10Desonide Cream110

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

151 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized56490
2Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized24200
3Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized11110
4Haerbin Tian Mei Pharma Co., Ltd. romanized1060
5Janssen-Cilag International NV820
6medac Gesellschaft für klinische Spezialpr?parate mbH810
7Yi Chang Ren Fu Pharma Co., Ltd. romanized735
8Guizhou Liang Ji Pharma Co., Ltd. romanized660
9Heilongjiang Kui Hua Pharma Co., Ltd. romanized650
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

59 this week

AcceptedDrugApplicants
2021/12/15Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2102207 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2021/12/15New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSS2101063 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/12/15New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101062 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/12/15New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101061 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/12/15New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101060 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/12/15New drug · Class 3.2 重组人生长激素注射液 · No verified English nameCXSS2101059 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/12/15New drug · Class 1 QX005N注射液 · No verified English nameCXSL2101486 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/12/15New drug · Class 2.4 Apatinib Mesylate TabletsCXHS2101056 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/12/15New drug · Class 2.2 盐酸美金刚口溶膜 · No verified English nameCXHL2101756 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2021/12/15New drug · Class 1 富马酸卢帕替芬胶囊 · No verified English nameCXHL2101739 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized
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

29 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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