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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 225 drug applications between 24 August 2022 and 30 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.

2022/08/24 – 2022/08/30

Period
2022/08/24 to 2022/08/30, 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
225
Drugs with new generic filings (by drug name, de-duplicated)
38
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

225filings, 51 of them generic

By application type

Application typeFilings
Supplement104
Generic51
New drug34
Import21
Import re-registration8
Unspecified7

By drug type

Drug typeFilings
Chemical drug147
Therapeutic biologic51
TCM20
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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Solution For Inhalation334
2Tacrolimus Ointment216
3Piracetam Injection219
4Vortioxetine Hydrobromide Tablets2110
5Potassium Chloride Injection2110
6Ceftazidime for Injection214
7盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
8Memantine Hydrochloride Oral Solution210
9Moxifloxacin Hydrochloride Eye Drops214
10Arotinolol Hydrochloride Tablets212

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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized980
2Roche Pharma (Schweiz) AG920
3Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized880
4Shenyang San Sheng Pharmaceutical Co., Ltd. romanized722
5Eli Lilly and Company510
6Hubei Kang Wei Yuan Pharma Co., Ltd. romanized440
7CISEN PHARMACEUTICAL CO., LTD.433
8Janssen Research & Development LLC420
9Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized420
10Hunan Ke Lun Pharmaceutical 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

68 this week

AcceptedDrugApplicants
2022/08/30Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2200149 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/08/30Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2200148 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2022/08/30Import · Class 1 SLS-005 · No verified English nameJXHL2200263 Seelos Therapeutics Inc.; Syneos Health (Beijing) Inc. Ltd.
2022/08/30Generic · Class 3 Magnesium Sulfate InjectionCYHS2201417 Jiangxi Qing Feng Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/08/30Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2201411 Shandong Yi Kang Pharma Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200423 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200422 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2200421 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 1 BA2101注射液 · No verified English nameCXSL2200420 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/08/30New drug · Class 1 BA2101注射液 · No verified English nameCXSL2200419 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/08/30New drug · Class 1 JS014注射液 · No verified English nameCXSL2200418 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/30New drug · Class 1 AK130注射液 · No verified English nameCXSL2200410 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/08/30New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2200401 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized
2022/08/30New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200635 Qilu Pharmaceutical Co., Ltd.
2022/08/30New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200634 Qilu Pharmaceutical Co., Ltd.
2022/08/30New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200633 Qilu Pharmaceutical Co., Ltd.
2022/08/29Import · Class 1 Cytopeutics?脐带间充质干细胞(Neuroncell-EX) · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.JXSL2200142 Cytopeutics Sdn Bhd (MY)
2022/08/29Generic · Class 3 Citicoline InjectionCYHS2201408 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Topfond Pharmaceutical Co., Ltd.
2022/08/29Generic · Class 3 Citicoline InjectionCYHS2201407 Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Topfond Pharmaceutical Co., Ltd.
2022/08/29Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2201406 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized
2022/08/29Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2201405 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized
2022/08/29Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2201398 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2022/08/29Generic · Class 3 Aripiprazole Oral SolutionCYHS2201397 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/08/29New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2200411 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2022/08/29New drug · Class 1 ESG206注射液 · No verified English nameCXSL2200408 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2022/08/29New drug · Class 1 DP303c · No verified English nameCXSL2200407 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/08/29New drug · Class 1 TR115片 · No verified English nameCXHL2200632 Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized
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.

38 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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