YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 164 drug applications between 1 June 2021 and 7 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 25 drug names.

2021/06/01 – 2021/06/07

Period
2021/06/01 to 2021/06/07, 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
164
Drugs with new generic filings (by drug name, de-duplicated)
25
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

164filings, 39 of them generic

By application type

Application typeFilings
Supplement82
Generic39
New drug20
Import16
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug106
Therapeutic biologic28
TCM25
Prophylactic biologic5

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Erlotinib Hydrochloride Tablets320
2Latamoxef Sodium for Injection311
3Edoxaban Tosilate Tablets319
4Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
5Bromhexine Hydrochloride Injection228
6Linezolid and Glucose Injection213
7Sodium Hyaluronate Eye Drops2130
8硫酸沙丁胺醇雾化吸入溶液 · No verified English name210
9Febuxostat Tablets2112
10Calcitriol Soft Capsules211

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

102 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized14130
2Hubei Long Fu Pharma Co., Ltd. romanized550
3Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized430
4Roche Pharma(Schweiz)AG410
5Qilu Pharmaceutical Co., Ltd.332
6Rui Yang Pharmaceutical Co., Ltd. romanized320
7Bristol-Myers Squibb Company310
8Hua Yi Tai Kang Pharma Co., Ltd. romanized313
9Shandong Run Ze Pharmaceutical Co., Ltd. romanized313
10Hainan Xian Sheng Pharma Co., Ltd. romanized313

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

44 this week

AcceptedDrugApplicants
2021/06/07Import · Class 2.1 雷珠单抗注射液 · No verified English nameJXSL2101039 F. Hoffmann-La Roche Ltd.; Roche (China) Holding Ltd.
2021/06/07Import · Class 1 LNP023胶囊 · No verified English nameJXHL2101079 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/06/07Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2101272 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2021/06/07Generic · Class 3 Furosemide InjectionCYHS2101269 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/06/07Generic · Class 3 Calcitriol Soft CapsulesCYHS2101214 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized
2021/06/07New drug · Class 1 MRG004A · No verified English nameCXSL2101115 Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized
2021/06/07New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101107 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2021/06/07New drug · Class 1 SS-001 · No verified English nameCXHL2101180 Bai Shan Pharma (Suzhou) Co., Ltd. romanized
2021/06/07New drug · Class 1 SS-001 · No verified English nameCXHL2101179 Bai Shan Pharma (Suzhou) Co., Ltd. romanized
2021/06/07New drug · Class 1 TQA3605片 · No verified English nameCXHL2101176 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/06/07New drug · Class 1 TQA3605片 · No verified English nameCXHL2101175 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/06/04Import · Class 1 Nipocalimab注射液 · No verified English nameJXSL2101038 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2021/06/04Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2101262 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2021/06/04Generic · Class 3 Citicoline Sodium InjectionCYHS2101242 CISEN PHARMACEUTICAL CO., LTD.
2021/06/04Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2101225 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2021/06/04New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2101004 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/06/04New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2101106 Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2021/06/04New drug · Class 1 TLZ-16-CL胶囊 · No verified English nameCXHL2101174 Beijing Tai Zhou Li Ze Pharmaceuticals Technology Co., Ltd. romanized
2021/06/04New drug · Class 1 TLZ-16-CL胶囊 · No verified English nameCXHL2101173 Beijing Tai Zhou Li Ze Pharmaceuticals Technology Co., Ltd. romanized
2021/06/04New drug · Class 2.4 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101172 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2021/06/03Import · Class 1 HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101037 Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/06/03Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101078 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/06/03Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101077 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/06/03Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101254 Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2021/06/03Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101253 Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2021/06/03Generic · Class 3 Latamoxef Sodium for InjectionCYHS2101252 Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2021/06/03Generic · Class 3 Milrinone and Glucose InjectionCYHS2101246 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2021/06/03New drug · Class 1 EMB-06 注射液 · No verified English nameCXSL2101108 Shanghai An Mai Bio Technology Co., Ltd. romanized
2021/06/03New drug · Class 1 SYHX1903片 · No verified English nameCXHL2101171 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2021/06/03New drug · Class 1 SYHX1903片 · No verified English nameCXHL2101170 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

14 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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