YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 237 drug applications between 8 July 2022 and 14 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 34 drug names.

2022/07/08 – 2022/07/14

Period
2022/07/08 to 2022/07/14, 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
237
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
3

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

237filings, 46 of them generic

By application type

Application typeFilings
Supplement121
Generic46
Import31
New drug21
Import re-registration9
Unspecified7
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug179
Therapeutic biologic34
TCM19
Prophylactic biologic4
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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection442
2Hydromorphone Hydrochloride Extended-Release Tablets310
3Ruxolitinib Phosphate Tablets3127
4Aripiprazole Orally Disintegrating tablets311
5Ornidazole Injection210
6Oxytocin Injection218
7Calcium Gluconate in Sodium Chloride Injection215
8Scopolamine Butylbromide Injection117
9低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name113
10低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name114

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang No.4 Pharmaceutical Co., Ltd.1242
2Actelion Pharmaceuticals Ltd810
3Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized720
4Novo Nordisk A/S620
5LES LABORATOIRES SERVIER530
6Novartis Pharma AG520
7CSL Behring GmbH510
8Shandong Dong E Dong Ru E Jiao Pharmaceutical Co., Ltd. romanized440
9Pfizer Europe MA EEIG430
10Novartis Europharm Limited420

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
2022/07/14Import · Class 3.1 艾加莫德α注射液 · No verified English nameJXSS2200022 argenx BV; Vetter Pharma-Fertigung GmbH & Co. KG; Zai Lab (Shanghai) Co. Ltd.
2022/07/14Import · Class 1 CAEL-101注射液 · No verified English nameJXSL2200120 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2022/07/14Import · Class 1 CPI-006注射液 · No verified English nameJXSL2200119 Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals Co. Ltd.
2022/07/14Import · Class 1 LTT462 · No verified English nameJXHL2200189 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 LTT462 · No verified English nameJXHL2200188 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 TNO155 · No verified English nameJXHL2200187 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 TNO155 · No verified English nameJXHL2200186 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 TNO155 · No verified English nameJXHL2200185 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 2.4 Trametinib TabletsJXHL2200184 Novartis Europharm Limited; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 2.4 Trametinib TabletsJXHL2200183 Novartis Europharm Limited; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 2.4 Dabrafenib mesylate CapsulesJXHL2200182 Novartis Europharm Limited; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 2.4 Dabrafenib mesylate CapsulesJXHL2200181 Novartis Europharm Limited; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 Xevinapant口服溶液 · No verified English nameJXHL2200180 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2022/07/14Import · Class 1 RO7223280注射液 · No verified English nameJXHL2200178 F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/14Import · Class 1 BLU-945胶囊 · No verified English nameJXHL2200177 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/07/14Import · Class 1 BLU-945胶囊 · No verified English nameJXHL2200176 Blueprint Medicines Corporation; Zai Lab (Shanghai) CO. Ltd.
2022/07/14Generic · Class 3 Aminocaproic Acid InjectionCYHS2201070 Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized
2022/07/14Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2201064 Lang Tian Pharma (Hubei) Co., Ltd. romanized
2022/07/14Generic · Class 3 Oxytocin InjectionCYHS2201061 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2022/07/14Generic · Class 3 Oxytocin InjectionCYHS2201060 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2022/07/14Generic · Class 3 Entecavir oral solutionCYHS2201059 Hubei Kang Yuan Pharma Co., Ltd. romanized
2022/07/14Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2201055 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/07/14New drug · Class 3.2 利拉鲁肽注射液 · No verified English nameCXSS2200065 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2022/07/14New drug · Class 3.2 利拉鲁肽注射液 · No verified English nameCXSS2200064 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2022/07/14New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSL2200320 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/07/14New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2200317 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2022/07/14New drug · Class 1 QY201片 · No verified English nameCXHL2200502 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/07/14New drug · Class 1 QY201片 · No verified English nameCXHL2200501 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/07/14New drug · Class 1 GH55胶囊 · No verified English nameCXHL2200500 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/07/14New drug · Class 1 GH55胶囊 · No verified English nameCXHL2200499 Qin Hao Pharmaceuticals (Suzhou) 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.

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