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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 221 drug applications between 15 June 2021 and 21 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.

2021/06/15 – 2021/06/21

Period
2021/06/15 to 2021/06/21, 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
221
Drugs with new generic filings (by drug name, de-duplicated)
24
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

221filings, 32 of them generic

By application type

Application typeFilings
Supplement124
New drug36
Generic32
Import18
Unspecified9
Import re-registration2

By drug type

Drug typeFilings
Chemical drug166
Therapeutic biologic39
TCM15
Prophylactic biologic1

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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Celecoxib Capsules415
2Levetiracetam Oral Solution223
3头孢克肟胶囊 · No verified English name212
4注射用头孢曲松钠/氯化钠注射液 · No verified English name213
5Magnesium Sulfate Injection217
6Valsartan Film-Coated Tablets210
7Propofol Medium And Long Chain Fat Emulsion Injection113
8吸入用七氟烷 · No verified English name110
9Ipratropium Bromide Inhalation Solution112
10Ambroxol Hydrochloride Solution For Inhalation1110

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1The Wellcome Foundation Limited720
2Wuhan Fu Xing Bio Pharma Co., Ltd. romanized610
3Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized540
4CSPC OUYI PHARMACEUTICAL CO., LTD.520
5Bayer AG510
6IPSEN PHARMA510
7Lian Cardiovascular Limited510
8Haerbin Han Bang Medical Technology Co., Ltd. romanized510
9Hangzhou Sen Ze Pharmaceuticals Technology Co., Ltd. romanized440
10Qilu Pharmaceutical Co., Ltd.420

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

63 this week

AcceptedDrugApplicants
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101099 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101098 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101097 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101096 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Palovarotene胶囊 · No verified English nameJXHL2101095 IPSEN PHARMA; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/06/21Import · Class 1 Afuresertib片 · No verified English nameJXHL2101094 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Afuresertib片 · No verified English nameJXHL2101093 Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd.
2021/06/21Import · Class 1 Etrasimod片 · No verified English nameJXHL2101082 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Import · Class 1 Etrasimod片 · No verified English nameJXHL2101081 Arena Pharmaceuticals Inc.; Everest Medicines (China) Co. Ltd
2021/06/21Generic · Class 3 Ornidazole InjectionCYHS2101322 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Tong Hua Jin Ma Pharma Group Co., Ltd. romanized
2021/06/21New drug · Class 1 QX004N注射液 · No verified English nameCXSL2101142 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/06/21New drug · Class 1 BDB-001注射液 · No verified English nameCXSL2101141 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized; Beijing De Feng Rui Bio Technology Co., Ltd. romanized
2021/06/21New drug · Class 2.4 环泊酚注射液 · No verified English nameCXHS2101025 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2021/06/21New drug · Class 1 OB756片 · No verified English nameCXHL2101216 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2021/06/21New drug · Class 1 EN002凝胶 · No verified English nameCXHL2101215 En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized
2021/06/21New drug · Class 1 EN002凝胶 · No verified English nameCXHL2101214 En Kang Pharma Technology (Guangzhou) Co., Ltd. romanized
2021/06/18Generic · Class 3 Nifedipine Extended-Release TabletsCYHS2101305 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2021/06/18New drug · Class 1 EX101注射液 · No verified English nameCXSL2101140 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/18New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101139 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2021/06/18New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101138 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/06/18New drug · Class 1 注射用IMM01 · No verified English nameCXSL2101109 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/06/18New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101206 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/18New drug · Class 1 SYHX1901片 · No verified English nameCXHL2101205 CSPC OUYI PHARMACEUTICAL CO., LTD.
2021/06/18New drug · Class 2.4 注射用苏拉明钠 · No verified English nameCXHL2101187 Guangdong Kang Da Pharmaceutical Co., Ltd. romanized
2021/06/17Import · Class 1 注射用STP705 · No verified English nameJXHL2101092 Sirnaomics Inc.; Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd.
2021/06/17Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2101301 Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/06/17Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2101300 Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/06/17Generic · Class 3 Magnesium Sulfate InjectionCYHS2101298 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2021/06/17Generic · Class 3 Magnesium Sulfate InjectionCYHS2101297 Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2021/06/17Generic · Class 3 Treprostinil InjectionCYHS2101273 Jiangsu Zhong Qiang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.

33 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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