YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 443 drug applications between 28 January 2023 and 3 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 85 drug names.

2023/01/28 – 2023/02/03

Period
2023/01/28 to 2023/02/03, 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
443
Drugs with new generic filings (by drug name, de-duplicated)
85
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

443filings, 117 of them generic

By application type

Application typeFilings
Supplement197
Generic117
New drug83
Import re-registration20
Import19
Unspecified7

By drug type

Drug typeFilings
Chemical drug356
TCM42
Therapeutic biologic41
Prophylactic biologic4

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

85 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution5323
2Phenylephrine Hydrochloride Injection425
3Minoxidil Topical Solution420
4Peramivir Injection327
5Amoxicillin Sodium for Injection310
6Doxofylline Injection225
7Levosimendan Injection221
8Famotidine Injection228
9Dobutamine Hydrochloride Injection223
10Phloroglucinol Injection222

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

256 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized13120
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD830
3Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized810
4Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized770
5Sichuan Kelun Pharmaceutical Co., Ltd.751
6Qilu Pharmaceutical Co., Ltd.741
7Anhui Pioneer Pharmaceutical Co., Ltd620
8Bracco Imaging Italia s.r.l.610
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized543
10Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized520

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

150 this week

AcceptedDrugApplicants
2023/02/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300328 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/02/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300327 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/02/03Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2300326 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/02/03Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2300325 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/02/03Generic · Class 3 Amoxicillin Sodium for InjectionCYHS2300324 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/02/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300323 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2023/02/03Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300322 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/02/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300321 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2023/02/03Generic · Class 3 Fexofenadine Hydrochloride Oral SuspensionCYHS2300319 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/02/03Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2300317 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/02/03Generic · Class 3 Fudosteine oral solutionCYHS2300313 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/02/03Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHL2300016 Yuan Zi Gao Ke Co., Ltd. romanized
2023/02/03New drug · Class 1 注射用RC108 · No verified English nameCXSL2300077 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/02/03New drug · Class 1 SBK007片 · No verified English nameCXHL2300161 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2023/02/03New drug · Class 2.1; 2.2; 2.4 QLM3003软膏 · No verified English nameCXHL2300160 Qilu Pharmaceutical Co., Ltd.
2023/02/03New drug · Class 2.1; 2.2; 2.4 QLM3003软膏 · No verified English nameCXHL2300159 Qilu Pharmaceutical Co., Ltd.
2023/02/03New drug · Class 2.1; 2.2; 2.4 QLM3003软膏 · No verified English nameCXHL2300158 Qilu Pharmaceutical Co., Ltd.
2023/02/02Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2300031 AstraZeneca UK Limited; AstraZeneca Investment (China) Co. Limited
2023/02/02Import · Class 1 ALXN1720注射液 · No verified English nameJXSL2300030 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2023/02/02Generic · Class 3 Ornidazole InjectionCYHS2300311 Hunan Jiudian Pharmaceutical Co., Ltd; Kang Pu Pharma Co., Ltd. romanized
2023/02/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300309 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/02/02Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300308 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/02/02Generic · Class 3 复方匹可硫酸钠颗粒 · No verified English nameCYHS2300307 Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized
2023/02/02Generic · Class 3 Peramivir InjectionCYHS2300306 Lang Tian Pharma (Hubei) Co., Ltd. romanized
2023/02/02Generic · Class 3 Bromhexine Hydrochloride TabletsCYHS2300305 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized
2023/02/02Generic · Class 3 Peramivir InjectionCYHS2300304 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2023/02/02Generic · Class 3 Peramivir InjectionCYHS2300303 Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2023/02/02Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2300301 Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/02/02Generic · Class 3 Indobufen TabletsCYHS2300300 Hunan Jiudian Pharmaceutical Co., Ltd
2023/02/02Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300296 Hua Cui International Bio Technology (Guangdong) Co., Ltd. romanized; Xi Nan Pharma Co., Ltd. romanized

120 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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