YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 383 drug applications between 16 February 2023 and 22 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 64 drug names.

2023/02/16 – 2023/02/22

Period
2023/02/16 to 2023/02/22, 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
383
Drugs with new generic filings (by drug name, de-duplicated)
64
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

383filings, 93 of them generic

By application type

Application typeFilings
Supplement206
Generic93
New drug32
Import24
Import re-registration22
Unspecified6

By drug type

Drug typeFilings
Chemical drug286
TCM57
Therapeutic biologic37
Prophylactic 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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4323
2Roxatidine Acetate Hydrochloride For Injection335
3Levofloxacin Tablets327
4Tranexamic Acid Injection3111
5Duloxetine Hydrochloride Enteric Capsules314
6Oseltamivir Phosphate Capsules3139
7Lidocaine and Prilocaine Cream2224
8Sodium Hyaluronate Eye Drops2230
9Mannitol-S Injection221
10Elagolix 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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenyang Jun Yuan Pharma Co., Ltd. romanized16100
2Guangxi Yu Yuan Pharma Co., Ltd. romanized660
3Pfizer Inc.630
4NAPP PHARMACEUTICALS LIMITED610
5Chongqing Qian Fang Drug Research Co., Ltd. romanized540
6Shandong Lukang Pharmaceutical Co.,Ltd.520
7Rui Yang Pharmaceutical Co., Ltd. romanized522
8Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized440
9Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized434
10Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized430

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

87 this week

AcceptedDrugApplicants
2023/02/22Import · Class 3.1 安纳白介素注射液(预充式) · No verified English nameJXSS2300017 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2023/02/22Import · Class 2.2 RO7198574 · No verified English nameJXSL2300039 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/02/22Import · Class 2.2 RO7198574 · No verified English nameJXSL2300038 F.Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/02/22Import · Class 1 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2300032 ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd.
2023/02/22Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2300611 Jinan Jing Sheng Technology Co., Ltd. romanized; Wei Fang Zhong Shi Pharmaceutical Co., Ltd. romanized
2023/02/22Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2300610 Te Feng Pharmaceutical Co., Ltd. romanized
2023/02/22Generic · Class 3 Acetaminophen InjectionCYHS2300609 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/02/22Generic · Class 3 Acetaminophen InjectionCYHS2300608 Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/02/22New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2300147 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2023/02/22New drug · Class 2.2 派安普利单抗注射液 · No verified English nameCXSL2300146 Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized
2023/02/22New drug · Class 3.3 GLR1027注射液 · No verified English nameCXSL2300145 Gan Li Pharma Co., Ltd. romanized
2023/02/22New drug · Class 1 CTS2190胶囊 · No verified English nameCXHL2300241 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized
2023/02/22New drug · Class 1 CTS2190胶囊 · No verified English nameCXHL2300240 Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized
2023/02/22New drug · Class 2.2 孟鲁司特钠凝胶 · No verified English nameCXHL2300239 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2023/02/22New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2300238 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2023/02/21Import · Class 1 PRV-3279 · No verified English nameJXSL2300037 Provention Bio Inc; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD.
2023/02/21Import · Class 1 GDC-0077 · No verified English nameJXHL2300031 F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/02/21Import · Class 1 GDC-0077 · No verified English nameJXHL2300029 F. Hoffmann-La Roche Ltd
2023/02/21Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2300603 Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Potassium Chloride GranulesCYHS2300600 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/02/21Generic · Class 3 Potassium Chloride GranulesCYHS2300599 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/02/21Generic · Class 3 Minoxidil LinimentCYHS2300598 Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Minoxidil LinimentCYHS2300597 Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300596 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Aripiprazole Oral SolutionCYHS2300595 Guangdong Nan Guo Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2300594 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/02/21Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2300585 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/02/21Generic · Class 3 Nicorandil for InjectionCYHS2300584 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/02/21Generic · Class 3 Nicorandil for InjectionCYHS2300583 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/02/21Generic · Class 3 Flurbiprofen Axetil InjectionCYHL2300026 YaoPharma Co., Ltd.

57 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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