YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 323 drug applications between 18 August 2022 and 24 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 42 drug names.

2022/08/18 – 2022/08/24

Period
2022/08/18 to 2022/08/24, 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
323
Drugs with new generic filings (by drug name, de-duplicated)
42
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

323filings, 62 of them generic

By application type

Application typeFilings
Supplement167
Generic62
New drug52
Import25
Import re-registration10
Unspecified7

By drug type

Drug typeFilings
Chemical drug238
Therapeutic biologic51
TCM30
Biologic3
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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Bicarbonate Ringer’s Injection321
2Magnesium Sulfate Injection317
3Oseltamivir Phosphate Capsules3139
4Sitagliptin Phosphate Tablets312
5Gadopentetic Acid Dimeglumine Salt Injection319
6Peramivir Injection227
7Esmolol Hydrochloride Injection223
8Tadalafil Tablets2123
9Bromhexine Hydrochloride Solution For Inhalation211
10Tobramycin Eye Drops212

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

170 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized16150
2Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized15150
3Guo Yao Group Gong Ye Co., Ltd. romanized12120
4Hubei Mei Lin Pharma Co., Ltd. romanized1060
5Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized990
6Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized880
7Novartis Pharma AG730
8Li Zhu Group Li Zhu Pharmaceutical Factory romanized610
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.535
10Bristol-Myers Squibb Pharma EEIG510

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

96 this week

AcceptedDrugApplicants
2022/08/24Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2200140 F. Hoffmann -La Roche Ltd; Roche (China) Holding Ltd
2022/08/24Import · Class 2.4 INC280 · No verified English nameJXHL2200256 Janssen Research & Development LLC; China Novartis Institutes for BioMedical Research Co. Ltd
2022/08/24Import · Class 2.4 INC280 · No verified English nameJXHL2200255 Janssen Research & Development LLC; China Novartis Institutes for BioMedical Research Co. Ltd
2022/08/24Import · Class 1 JDQ443片 · No verified English nameJXHL2200254 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/08/24Import · Class 1 JDQ443片 · No verified English nameJXHL2200253 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/08/24Import · Class 1 NORA520片 · No verified English nameJXHL2200245 Gerbera Therapeutics Inc.; Nanjing Noratech Pharmaceuticals. Ltd
2022/08/24Import · Class 1 NORA520片 · No verified English nameJXHL2200244 Gerbera Therapeutics Inc.; Nanjing Noratech Pharmaceuticals. Ltd
2022/08/24New drug · Class 1 肿瘤浸润T淋巴细胞 · No verified English nameCXSL2200399 Beijing Xun Sheng Bio Yi Xue Research Co., Ltd. romanized
2022/08/24New drug · Class 1 注射用BGB-B167 · No verified English nameCXSL2200398 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/08/24New drug · Class 1 BR790片 · No verified English nameCXHL2200619 Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/24New drug · Class 1 BR790片 · No verified English nameCXHL2200618 Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/24New drug · Class 1 HLX208片 · No verified English nameCXHL2200616 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/08/24New drug · Class 1 HRS-1358片 · No verified English nameCXHL2200615 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/08/24New drug · Class 1 HRS-1358片 · No verified English nameCXHL2200614 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/08/24New drug · Class 2.2 华法林钠颗粒 · No verified English nameCXHL2200613 Xinjiang Te Feng Pharma Co., Ltd. romanized
2022/08/23Import · Class 1 Peresolimab注射液 · No verified English nameJXSL2200141 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/08/23Import · Class 1.1 MVA-BN-RSV疫苗 · No verified English nameJXSL2200138 Bavarian Nordic A/S; Nuance Pharma (Shanghai) Co. Ltd.
2022/08/23Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200134 Merck Sharp &. Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200252 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200251 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200250 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200249 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201367 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201366 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201365 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201364 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201363 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Hydrotalcite SuspensionCYHS2201360 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/23Generic · Class 3 Peramivir InjectionCYHS2201359 Wen Zhou Hai He Pharma Co., Ltd. romanized; Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2022/08/23Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201356 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized

66 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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