YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 85 drug applications between 1 May 2024 and 7 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 13 drug names.

2024/05/01 – 2024/05/07

Period
2024/05/01 to 2024/05/07, 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
85
Drugs with new generic filings (by drug name, de-duplicated)
13
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

85filings, 18 of them generic

By application type

Application typeFilings
Supplement47
Generic18
New drug9
Import6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug56
TCM15
Therapeutic biologic13
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

13 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution2134
2Procaterol Hydrochloride Solution for Inhalation212
3Perindopril arginine and amlodipine besylate tablets213
4Dabigatran Etexilate Capsules212
5Avanafil Tablets212
6Sodium Picosulfate Oral Solution110
7Perindopril arginine and amlodipine besylate tablets110
8Perindopril Arginine and Amlodipine Besylate Tablets(III)113
9氯化钙注射液 · No verified English name116
10Urapidil Hydrochloride 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

57 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Sai Wei Pharma Co., Ltd. romanized510
2Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized440
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized440
4Jiangxi Shimei Pharmaceutical Co., Ltd434
5Takeda Pharmaceuticals International AG Ireland Branch310
6Anhui Jin Ma Pharma Co., Ltd. romanized220
7Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized220
8AbbVie Inc.210
9Genzyme Corporation210
10GlaxoSmithKline Trading Services Limited210

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

24 this week

AcceptedDrugApplicants
2024/05/07Import · Class 1 Fitusiran注射液 · No verified English nameJXHS2400034 Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd.
2024/05/07Import · Class 1 Fitusiran注射液 · No verified English nameJXHS2400033 Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd.
2024/05/07Import · Class 1 RO7434656注射液 · No verified English nameJXHL2400098 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/05/07Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2400097 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/05/07Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2400096 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2024/05/07Generic · Class 3 Minoxidil LinimentCYHS2401338 Xian De Li Bio Chemical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401337 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401336 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/07Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2401335 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/05/07Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2401334 Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2024/05/07Generic · Class 3 铜[64Cu]氧奥曲肽注射液 · No verified English nameCYHL2400082 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2024/05/07Generic · Class 3 Sodium Picosulfate Oral SolutionCYHL2400081 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized
2024/05/07New drug · Class 1.1 清血败毒丸 · No verified English nameCXZL2400023 Jiangsu Zhong Yong Hong Rui Pharmaceutical Co., Ltd. romanized
2024/05/07New drug · Class 1.2 带状疱疹IN001 mRNA疫苗 · No verified English nameCXSL2400287 Shenzhen Shen Xin Bio Technology Co., Ltd. romanized
2024/05/07New drug · Class 1 注射用QLS4131 · No verified English nameCXSL2400286 Qilu Pharmaceutical Co., Ltd.
2024/05/06Generic · Class 3 Avanafil TabletsCYHS2401333 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2024/05/06Generic · Class 3 Avanafil TabletsCYHS2401332 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2024/05/06New drug · Class 1 TAL-T细胞注射液 · No verified English nameCXSL2400285 Guangzhou Fan En Bio Technology Co., Ltd. romanized
2024/05/01Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400084 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/05/01New drug · Class 1 CNK-UT002细胞注射液 · No verified English nameCXSL2400284 Yi Zun Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2024/05/01New drug · Class 1 注射用sacituzumab tirumotecan · No verified English nameCXSL2400283 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/05/01New drug · Class 1 酒石酸泰贝西利胶囊 · No verified English nameCXHS2400039 Bei Da Pharma Co., Ltd. romanized
2024/05/01New drug · Class 1 SGB-3908注射液 · No verified English nameCXHL2400426 Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized
2024/05/01New drug · Class 2.2 HZ031口溶膜 · No verified English nameCXHL2400425 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized

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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