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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 264 drug applications between 3 June 2023 and 9 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 48 drug names.

2023/06/03 – 2023/06/09

Period
2023/06/03 to 2023/06/09, 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
264
Drugs with new generic filings (by drug name, de-duplicated)
48
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

264filings, 72 of them generic

By application type

Application typeFilings
Supplement119
Generic72
New drug43
Import18
Import re-registration7
Unspecified5

By drug type

Drug typeFilings
Chemical drug186
Therapeutic biologic45
TCM29
Biologic2
Prophylactic biologic2

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

48 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Topical Solution320
2Lactulose Oral Solution3134
3注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name312
4Neostigmine Methylsulfate Injection314
5Nitroglycerin Sublingual Tablets313
6预充式甲氨蝶呤注射液 · No verified English name310
7Potassium Chloride Injection2210
8Hydrotalcite Chewable Tablets226
9Phloroglucinol Injection222
10Procaterol Hydrochloride Solution for Inhalation212

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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
2AbbVie Inc.530
3Novo Nordisk A/S510
4Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized510
5Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized440
6YaoPharma Co., Ltd.421
7Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized330
8Hua Run Shuang He Pharma Co., Ltd. romanized331
9Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized330
10Guangxi Tai Nuo 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

77 this week

AcceptedDrugApplicants
2023/06/09New drug · Class 2.2 注射用替奈普酶 · No verified English nameCXSL2300403 Shanghai Feng Hua Tian Li Tong Biopharmaceuticals Co., Ltd. romanized
2023/06/09New drug · Class 1 硫酸艾玛昔替尼片 · No verified English nameCXHS2300052 Rui Shi Biopharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/06/08Generic · Class 3 Potassium Chloride InjectionCYHS2301578 Chengdu Giantech Hi-technology Development Co., Ltd.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHS2301575 Nanjing Han Xin Pharmaceuticals Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301574 Beijing Hai Jing Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/06/08Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2301571 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 Piracetam InjectionCYHS2301570 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/06/08Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2301569 Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301562 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301561 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/06/08Generic · Class 3 Risedronate Sodium TabletsCYHL2300076 Kunming Ji Da Pharmaceutical Co., Ltd. romanized
2023/06/08New drug · Class 1 YH01注射液 · No verified English nameCXSL2300401 Beijing Yin Mei Wei Lai Biopharmaceuticals Technology Co., Ltd. romanized
2023/06/08New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2300400 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/06/08New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2300625 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2023/06/08New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2300624 Qilu Pharmaceutical Co., Ltd.
2023/06/08New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2300623 Qilu Pharmaceutical Co., Ltd.
2023/06/08New drug · Class 1 XH-S002散 · No verified English nameCXHL2300622 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2023/06/08New drug · Class 1 XH-S002散 · No verified English nameCXHL2300621 Zhejiang Xing Hao Peng Bo Pharmaceuticals Co., Ltd. romanized
2023/06/08New drug · Class 2.2 DM0201贴 · No verified English nameCXHL2300620 Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized
2023/06/08New drug · Class 2.2 DM0201贴 · No verified English nameCXHL2300619 Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized
2023/06/08New drug · Class 1 WXWH182片 · No verified English nameCXHL2300618 Jian Ai Shi Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2023/06/08New drug · Class 1 WXWH182片 · No verified English nameCXHL2300617 Jian Ai Shi Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2023/06/07Import · Class 2.2 注射用戈沙妥珠单抗 · No verified English nameJXSL2300105 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2023/06/07Import · Class 1 注射用sotatercept · No verified English nameJXSL2300104 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/06/07Import · Class 1 注射用sotatercept · No verified English nameJXSL2300103 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/06/07Import · Class 1 Astegolimab注射液 · No verified English nameJXSL2300102 F. Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2023/06/07Import · Class 1 TAK-676注射液 · No verified English nameJXHL2300137 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2023/06/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301558 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2301557 Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/06/07Generic · Class 3 Diprophylline InjectionCYHS2301556 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized

47 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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