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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 224 drug applications between 22 October 2022 and 28 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 41 drug names.

2022/10/22 – 2022/10/28

Period
2022/10/22 to 2022/10/28, 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
224
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
2

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

224filings, 50 of them generic

By application type

Application typeFilings
Supplement113
Generic50
New drug27
Unspecified13
Import13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug175
Therapeutic biologic21
TCM15
Biologic9
Prophylactic biologic4

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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Solution For Inhalation334
2Metaraminol Tartrate Injection222
3Olaparib Tablets210
4Flumazenil Injection212
5Urapidil Hydrochloride Injection216
6Ambroxol Hydrochloride Drops218
7Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules212
8盐酸西替利嗪滴剂 · No verified English name218
9Acetylcysteine Injection1153
10Diprophylline Injection117

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

145 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized12110
2Hubei Mei Lin Pharma Co., Ltd. romanized550
3Chengdu Shi Hai Tong Pharma Co., Ltd. romanized520
4Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized424
5Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized420
6AstraZeneca UK Limited410
7Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized410
8Merck Sharp & Dohme LLC330
9Shanxi Yi Qing Ke Pharma Co., Ltd. romanized330
10Boehringer Ingelheim International GmbH320

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

63 this week

AcceptedDrugApplicants
2022/10/28Import · Class 1 elranatamab · No verified English nameJXSL2200188 Pfizer Inc; Pfizer Investment CO. Ltd.
2022/10/28Import · Class 1 Aticaprant 薄膜包衣片 · No verified English nameJXHL2200317 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/28Import · Class 2.2; 2.4 Delgocitinib乳膏 · No verified English nameJXHL2200316 LEO Pharma A/S; LEO Pharma Consultancy (Shanghai) Company Limited
2022/10/28Import · Class 2.2 阿塞那平透皮贴剂 · No verified English nameJXHL2200315 LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute
2022/10/28Import · Class 2.2 阿塞那平透皮贴剂 · No verified English nameJXHL2200314 LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute
2022/10/28Import · Class 2.2 阿塞那平透皮贴剂 · No verified English nameJXHL2200313 LIAN HONG KONG LIMITED; Livzon (Group) Pharmaceutical Research Institute
2022/10/28Generic · Class 3 Ibuprofen InjectionCYHS2201847 Hainan He Rui Pharmaceutical Co., Ltd. romanized
2022/10/28Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2201846 Anhui Bai Ao Pharma Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2022/10/28Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2201844 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2022/10/28Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2201843 Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized
2022/10/28Generic · Class 3 Fluorouracil InjectionCYHS2201842 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized
2022/10/28New drug · Class 1 自体淋巴细胞注射液 · No verified English nameCXSL2200546 Beijing Kang Ai Rui Hao Bio Technology Co., Ltd. romanized
2022/10/28New drug · Class 2.2 孟鲁司特钠凝胶 · No verified English nameCXHL2200842 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2022/10/28New drug · Class 2.2 孟鲁司特钠凝胶 · No verified English nameCXHL2200841 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2022/10/28New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2200840 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2022/10/28New drug · Class 2.2; 2.4 孟鲁司特钠凝胶 · No verified English nameCXHL2200839 Ai Ti Ya (Shanghai) Pharmaceutical Co., Ltd. romanized
2022/10/28New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2200838 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2022/10/28New drug · Class 1 注射用HN0090 · No verified English nameCXHL2200837 Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2022/10/27Import · Class 3.1 度普利尤单抗注射液 · No verified English nameJXSL2200187 sanofi-aventis groupe; Sanofi(China) Investment Co. LTD
2022/10/27Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200312 AbbVie Inc.
2022/10/27Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200311 AbbVie Inc.
2022/10/27Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201838 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/10/27Generic · Class 3 Flumazenil InjectionCYHS2201837 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2022/10/27Generic · Class 3 Flumazenil InjectionCYHS2201836 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2022/10/27Generic · Class 3 Nimodipine Oral SolutionCYHS2201834 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/10/27Generic · Class 3 Metaraminol Tartrate InjectionCYHS2201833 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2022/10/27New drug · Class 2.2 重组人乳头瘤病毒6/11/16/18型四价疫苗(汉逊酵母) · No verified English nameCXSL2200545 Jiangsu Rui Ke Bio Technology Co., Ltd. romanized
2022/10/27New drug · Class 1 KYS202002A 注射液 · No verified English nameCXSL2200544 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/10/27New drug · Class 1 HSK16149胶囊 · No verified English nameCXHS2200058 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized; Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized
2022/10/27New drug · Class 1 TQB3616胶囊 · No verified English nameCXHL2200836 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

33 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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