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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 296 drug applications between 20 August 2022 and 26 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 34 drug names.

2022/08/20 – 2022/08/26

Period
2022/08/20 to 2022/08/26, 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
296
Drugs with new generic filings (by drug name, de-duplicated)
34
Accepted this week, now under review
2

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

296filings, 54 of them generic

By application type

Application typeFilings
Supplement163
Generic54
New drug49
Import22
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug205
Therapeutic biologic51
TCM33
Prophylactic biologic4
Biologic3

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
1Acetylcysteine Solution For Inhalation334
2Potassium Chloride Injection3210
3Magnesium Sulfate Injection317
4Peramivir Injection227
5Esmolol Hydrochloride Injection223
6Sodium Bicarbonate Ringer’s Injection221
7Tacrolimus Ointment216
8Piracetam Injection219
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

155 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized16150
2Guo Yao Group Gong Ye Co., Ltd. romanized12120
3Hubei Mei Lin Pharma Co., Ltd. romanized1060
4Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized990
5Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized880
6Novartis Pharma AG730
7Shenyang San Sheng Pharmaceutical Co., Ltd. romanized722
8Li Zhu Group Li Zhu Pharmaceutical Factory romanized610
9Hubei Kang Wei Yuan Pharma Co., Ltd. romanized440
10Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized420

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
2022/08/26Import · Class 1 Ponsegromab 注射液 · No verified English nameJXSL2200147 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/08/26Import · Class 1 Ponsegromab 注射液 · No verified English nameJXSL2200146 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/08/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2200145 AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd.
2022/08/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2200144 AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd.
2022/08/26Import · Class 3.1 注射用A型肉毒毒素 · No verified English nameJXSL2200143 AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd.
2022/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2201394 Guangzhou Ai Qi Xi Pharmaceuticals Technology Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2201393 Guangzhou Ai Qi Xi Pharmaceuticals Technology Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2022/08/26Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201392 Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/26Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201391 Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/26Generic · Class 3 Peramivir InjectionCYHS2201390 Qinghai Chen Fei Pharmaceutical Co., Ltd. romanized
2022/08/26Generic · Class 3 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2201371 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2022/08/26Generic · Class 3 Pregabalin Extended release TabletsCYHL2200073 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/26New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSS2200076 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2022/08/26New drug · Class 1 RGT-264磷酸盐片 · No verified English nameCXHL2200631 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2022/08/26New drug · Class 1 RGT-264磷酸盐片 · No verified English nameCXHL2200630 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2022/08/26New drug · Class 1 注射用KMHH-03 · No verified English nameCXHL2200629 Beijing Kang Ming Hai Hui Bio Technology Co., Ltd. romanized
2022/08/25Generic · Class 3 Piracetam InjectionCYHS2201383 Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2022/08/25Generic · Class 3 Piracetam InjectionCYHS2201382 Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2022/08/25Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201376 CISEN PHARMACEUTICAL CO., LTD.
2022/08/25New drug · Class 1 注射用IBB0979 · No verified English nameCXSL2200402 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2022/08/25New drug · Class 1 GC101腺相关病毒注射液 · No verified English nameCXSL2200400 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/08/25New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2200628 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2022/08/25New drug · Class 1 CX1440胶囊 · No verified English nameCXHL2200627 Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized
2022/08/25New drug · Class 1 注射用XCCS605B · No verified English nameCXHL2200626 Shanghai Hua Yu Bio Technology Co., Ltd. romanized
2022/08/25New drug · Class 1 NRT6003注射液 · No verified English nameCXHL2200621 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2022/08/25New drug · Class 2.2 HF158K1 · No verified English nameCXHL2200617 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
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

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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