YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 315 drug applications between 9 June 2022 and 15 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 28 drug names.

2022/06/09 – 2022/06/15

Period
2022/06/09 to 2022/06/15, 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
315
Drugs with new generic filings (by drug name, de-duplicated)
28
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

315filings, 45 of them generic

By application type

Application typeFilings
Supplement179
Generic45
New drug43
Import29
Import re-registration12
Unspecified7

By drug type

Drug typeFilings
Chemical drug217
Therapeutic biologic52
TCM37
Biologic6
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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Atomoxetine Hydrochloride Capsules716
2Olanzapine Tablets314
3Olmesartan Medoxomil Tablets211
4Pravastatin Sodium Tablets212
5Pregabalin Capsules2112
6Pantoprazole Enteric-Coated Tablets211
7Rasagiline Mesylate Tablets215
8Dopamine Hydrochloride Injection213
9Oseltamivir Phosphate For Oral Suspension212
10Minoxidil Topical Solution210

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

162 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Pharmaceutical (Group) Co., Ltd. romanized23200
2Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized970
3Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
4ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.828
5F. Hoffmann-La Roche Ltd740
6Novo Nordisk A/S730
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized550
8Jiangxi Na Fu Tang Pharmaceutical Co., Ltd. romanized540
9Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized540
10Shenzhen Xin Li Tai Pharma 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

80 this week

AcceptedDrugApplicants
2022/06/14Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2200085 MedImmune LLC; AstraZeneca Investment (China) Co. Limited
2022/06/14Import · Class 2.2 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200146 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Import · Class 2.2; 2.4 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200145 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Import · Class 2.2; 2.4 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200144 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2200883 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2022/06/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200875 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2022/06/14Generic · Class 3 Folic Acid TabletsCYHS2200860 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized
2022/06/14New drug · Class 1 BC007抗体注射液 · No verified English nameCXSL2200267 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/06/14New drug · Class 1 注射用KJ103 · No verified English nameCXSL2200266 Shanghai Bao Ji Pharma Co., Ltd. romanized
2022/06/14New drug · Class 1 注射用SKB264 · No verified English nameCXSL2200265 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/06/14New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2200263 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2022/06/14New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2200386 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/06/14New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2200385 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/06/14New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2200384 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/06/14New drug · Class 1 TCIC-001颗粒 · No verified English nameCXHL2200383 Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized
2022/06/14New drug · Class 1 TCIC-001颗粒 · No verified English nameCXHL2200382 Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized
2022/06/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2200380 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/06/14New drug · Class 2.2 盐酸氨溴索口溶膜 · No verified English nameCXHL2200379 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized
2022/06/14New drug · Class 1 QLH12007片 · No verified English nameCXHL2200378 Qilu Pharmaceutical Co., Ltd.
2022/06/13Import · Class 3.1 地舒单抗注射液 · No verified English nameJXSS2200019 Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/13Import · Class 2.2 贝伐珠单抗注射液 · No verified English nameJXSL2200084 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/06/13Import · Class 3.3 雷珠单抗注射液 · No verified English nameJXSL2200083 Samsung Bioepis NL B.V.; Shanghai Affamed Therapeutics Co. Limited
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200143 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200142 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Import · Class 1 RO7435846片 · No verified English nameJXHL2200141 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2022/06/13Generic · Class 3 Venlafaxine Hydrochloride Extended Release TabletsCYHS2200865 Hainan Hui Gu Pharma Co., Ltd. romanized
2022/06/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200864 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/06/13Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200863 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/06/13Generic · Class 3 Minoxidil Topical SolutionCYHS2200862 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/06/13Generic · Class 3 Minoxidil Topical SolutionCYHS2200861 Jiangsu Vanguard Pharmaceutical Co., Ltd.

50 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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