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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 170 drug applications between 3 June 2021 and 9 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 24 drug names.

2021/06/03 – 2021/06/09

Period
2021/06/03 to 2021/06/09, 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
170
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

170filings, 36 of them generic

By application type

Application typeFilings
Supplement79
Generic36
New drug30
Import14
Import re-registration10
Unspecified1

By drug type

Drug typeFilings
Chemical drug118
Therapeutic biologic30
TCM17
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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Erlotinib Hydrochloride Tablets320
2Latamoxef Sodium for Injection311
3Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
4Ornidazole Injection210
5Obeticholic Acid Tablets210
6Levofloxacin Tablets217
7盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
8Atosiban Acetate Injection212
9Calcitriol Soft Capsules211
10Furosemide Injection116

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

100 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB630
2Bristol-Myers Squibb Pharma EEIG510
3Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized430
4Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized430
5Roche Pharma(Schweiz)AG410
6Hubei Long Fu Pharma Co., Ltd. romanized330
7Wu Hu Chen You Biopharmaceuticals Gong Cheng Co., Ltd. romanized320
8medac Gesellschaft für klinische Spezialpr?parate mbH310
9Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized310
10Hua Yi Tai Kang 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

54 this week

AcceptedDrugApplicants
2021/06/09Import · Class 1 BI 425809 片 · No verified English nameJXHL2101086 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/06/09Generic · Class 3 Obeticholic Acid TabletsCYHL2101014 Yangtze River Pharmaceutical Group Co., Ltd
2021/06/09Generic · Class 3 Obeticholic Acid TabletsCYHL2101013 Yangtze River Pharmaceutical Group Co., Ltd
2021/06/09New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101128 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/09New drug · Class 1 IBI110 · No verified English nameCXSL2101127 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/06/09New drug · Class 2.2 HRG2010胶囊 · No verified English nameCXHL2101178 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/09New drug · Class 2.2 HRG2010胶囊 · No verified English nameCXHL2101177 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/06/08Import · Class 1 注射用ZW25 · No verified English nameJXSL2101040 BeiGene Ltd.; BeiGene(Beijing)Co. Ltd
2021/06/08Generic · Class 3 Ornidazole InjectionCYHS2101279 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/06/08Generic · Class 3 Ornidazole InjectionCYHS2101278 Sichuan Kelun Pharmaceutical Co., Ltd.
2021/06/08Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101271 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/06/08Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2101270 Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized; Yangtze River Pharmaceutical Group Co., Ltd
2021/06/08New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101123 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/06/08New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101121 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101120 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2101119 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 1 SHR-1314注射液 · No verified English nameCXSL2101117 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/06/08New drug · Class 1 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2101116 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2101184 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2101183 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/06/08New drug · Class 1 复达那非片 · No verified English nameCXHL2101182 Xuan Zhu Bio Technology Co., Ltd. romanized
2021/06/08New drug · Class 1 复达那非片 · No verified English nameCXHL2101181 Xuan Zhu Bio Technology Co., Ltd. romanized
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

24 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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