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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 299 drug applications between 23 February 2023 and 1 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 47 drug names.

2023/02/23 – 2023/03/01

Period
2023/02/23 to 2023/03/01, 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
299
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
1

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

299filings, 59 of them generic

By application type

Application typeFilings
Supplement163
Generic59
New drug38
Import18
Import re-registration12
Unspecified9

By drug type

Drug typeFilings
Chemical drug213
TCM49
Therapeutic biologic30
Prophylactic biologic6
In vitro diagnostic reagent1

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution3246
2Sodium Valproate Oral Solution211
3Tacrolimus Sustained-release Capsules216
4Carbazochrome Sodium Sulfonate Injection211
5Brivaracetam Tablets2119
6Sodium Hyaluronate Eye Drops2130
7生理氯化钠溶液 · No verified English name2117
8Erlotinib Hydrochloride Tablets210
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
10Bromhexine Hydrochloride Oral Solution2122

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized13110
2Guangdong Song Xia Pharma Co., Ltd. romanized11110
3Guangxi Yu Yuan Pharma Co., Ltd. romanized630
4Bracco Imaging S.P.A.610
5Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized530
6Name not romanized434
7Aspen Pharmacare Australia Pty Ltd410
8Beijing Jia Cheng Biopharmaceuticals Technology Kai Fa Co., Ltd. romanized410
9Merck & Co. Inc.330
10Nei Menggu Yi Li Pharmaceutical Co., Ltd. romanized330

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

79 this week

AcceptedDrugApplicants
2023/03/01Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2300667 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300666 Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2300665 Name not romanized; Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300663 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/01Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300662 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/03/01New drug · Class 1.1 栀黄贴膏 · No verified English nameCXZL2300014 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2023/03/01New drug · Class 1 注射用SHR-2001 · No verified English nameCXSL2300163 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/01New drug · Class 2.2; 2.4 BTP0717 · No verified English nameCXHL2300258 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/02/28Import · Class 2.2 注射用阿地白介素 · No verified English nameJXSL2300043 CLINIGEN HEALTHCARE LIMITED
2023/02/28Import · Class 1 KM-001乳膏 · No verified English nameJXHL2300040 Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2023/02/28Import · Class 1 KM-001乳膏 · No verified English nameJXHL2300039 Kamari Pharma Ltd; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2023/02/28Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2300661 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/02/28Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2300656 Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized
2023/02/28Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300655 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized
2023/02/28New drug · Class 2.2 舒格利单抗注射液 · No verified English nameCXSS2300007 Hui Rui Investment Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2023/02/28New drug · Class 1 聚乙二醇化重组门冬酰胺酶注射液 · No verified English nameCXSL2300162 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2023/02/28New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2300161 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2023/02/28New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2300160 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2023/02/28New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2300159 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2023/02/27Import · Class 2.4 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300038 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/02/27Import · Class 2.4 阿扎胞苷薄膜衣片 · No verified English nameJXHL2300037 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb (China) Investment Co. Ltd.
2023/02/27Import · Class 1 AZD9833片 · No verified English nameJXHL2300035 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/02/27Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2300654 Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized
2023/02/27Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2300648 Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2300647 Chongqing Mai Chuan Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Wei Ao Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 Diprophylline InjectionCYHS2300643 Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/02/27Generic · Class 3 Famotidine InjectionCYHS2300642 Name not romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/02/27New drug · Class 1.1 十一方药酒 · No verified English nameCXZL2300013 Guangxi Zhong Pharmaceuticals University Di Yi Fu Shu Hospital (Guangxi Zhong Yi Hospital) romanized
2023/02/27New drug · Class 2.2 苏黄止咳颗粒 · No verified English nameCXZL2300012 Beijing Dong Fang Yun Jia Technology Development Co., Ltd. romanized
2023/02/27New drug · Class 1 SHR-1654注射液 · No verified English nameCXSL2300158 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized

49 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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