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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 388 drug applications between 3 February 2023 and 9 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 88 drug names.

2023/02/03 – 2023/02/09

Period
2023/02/03 to 2023/02/09, 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
388
Drugs with new generic filings (by drug name, de-duplicated)
88
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

388filings, 119 of them generic

By application type

Application typeFilings
Supplement173
Generic119
New drug73
Import14
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug281
Therapeutic biologic59
TCM47
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

88 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules434
2Phenylephrine Hydrochloride Injection425
3Calcium Levofolinate Injection410
4Oxaliplatin Injection324
5Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation3112
6Amoxicillin Sodium for Injection310
7Indobufen Tablets226
8Tropicamide Phenylephrine Eye Drops228
9Mecobalamin Tablets2216
10Lactulose Oral Solution2134

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

240 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized15150
2Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized666
3Run Yuan Pharmaceutical Co., Ltd. romanized660
4Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized650
5Anhui Pioneer Pharmaceutical Co., Ltd620
6Guangxi Yu Yuan Pharma Co., Ltd. romanized540
7Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized510
8Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized433
10Shenyang Jun Yuan 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

131 this week

AcceptedDrugApplicants
2023/02/09Import · Class 3.1 Aducanumab 注射液 · No verified English nameJXSL2300036 Biogen Inc.; Biogen Biotechnology (Shanghai) Co. Ltd
2023/02/09Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2300035 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2023/02/09Generic · Class 3 Indobufen TabletsCYHS2300426 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/02/09Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2300424 Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/02/09Generic · Class 3 L-Arginine L-Glutamate Hydrate InjectionCYHS2300419 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2023/02/09Generic · Class 3 Potassium Chloride GranulesCYHS2300415 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2023/02/09Generic · Class 3 Potassium Chloride GranulesCYHS2300414 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2023/02/09Generic · Class 3 Potassium Chloride Oral SolutionCYHS2300413 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2023/02/09Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2300411 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/02/09Generic · Class 3 Nicorandil for InjectionCYHS2300408 YaoPharma Co., Ltd.
2023/02/09New drug · Class 1.1 荆门上清丸 · No verified English nameCXZS2300005 Hubei Qi Jin Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Xiang Yang) Long Zhong Co., Ltd. romanized
2023/02/09New drug · Class 1.2 白头翁皂苷B4栓 · No verified English nameCXZL2300009 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2023/02/09New drug · Class 1.2 白头翁皂苷B4 · No verified English nameCXZL2300008 Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized
2023/02/09New drug · Class 1 SHR-2106注射液 · No verified English nameCXSL2300113 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/02/09New drug · Class 1 注射用TQB2103 · No verified English nameCXSL2300112 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/02/09New drug · Class 1 GSK4381562A注射液 · No verified English nameCXSL2300111 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2023/02/09New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2300110 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/02/09New drug · Class 1 NCR300注射液 · No verified English nameCXSL2300109 Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized
2023/02/09New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2300108 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2023/02/09New drug · Class 1 FT-003注射液 · No verified English nameCXSL2300107 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/02/09New drug · Class 1 FT-003注射液 · No verified English nameCXSL2300106 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/02/09New drug · Class 2.2 重组人截短型纤溶酶注射液 · No verified English nameCXSL2300105 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2023/02/09New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2300104 Kang Fang Pharma Co., Ltd. romanized
2023/02/09New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300103 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/02/09New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2300102 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2023/02/09New drug · Class 1 注射用AMT-151 · No verified English nameCXSL2300101 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/02/09New drug · Class 1 BBM-H803注射液 · No verified English nameCXSL2300100 Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized
2023/02/09New drug · Class 1 AK117注射液 · No verified English nameCXSL2300099 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/02/09New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2300098 Kang Fang Pharma Co., Ltd. romanized
2023/02/09New drug · Class 2.4 Edaravone and Dexborneol Concentrated Solution for InjectionCXHL2300190 Xian Sheng Pharma Co., Ltd. romanized

101 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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