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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 310 drug applications between 11 October 2022 and 17 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 51 drug names.

2022/10/11 – 2022/10/17

Period
2022/10/11 to 2022/10/17, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
51
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

310filings, 70 of them generic

By application type

Application typeFilings
Supplement172
Generic70
New drug36
Import15
Import re-registration15
Unspecified2

By drug type

Drug typeFilings
Chemical drug241
Therapeutic biologic30
TCM29
Prophylactic biologic8
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules324
2Compound α-Ketoacid Tablets220
3Glycopyrronium Bromide and Neostigmine Metilsulfate Injection223
4Methylprednisolone Tablets223
5丁酸氯维地平注射用乳剂 · No verified English name210
6复方醋酸钠林格注射液 · No verified English name212
7Vonoprazan Fumarate Tablets2160
8Paliperidone Extend-release Tablets212
9Telmisartan Tablets214
10Piperacillin Sodium And Tazobactam Sodium For Injection215

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Di Tai Pharmaceutical Co., Ltd. romanized12100
2Hainan Pharmaceutical Factory Co., Ltd. Wuhan Branch romanized10100
3Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized990
4AstraZeneca UK Limited710
5AbbVie Inc.420
6Bayer AG420
7Jiangsu En Hua Pharma Co., Ltd. romanized420
8Jiangsu Rui Shi Bio Technology Co., Ltd. romanized424
9Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized420
10Albireo AB410

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
2022/10/17New drug · Class 1 盐酸杰克替尼片 · No verified English nameCXHS2200054 Name not romanized
2022/10/17New drug · Class 1 MB-102注射液 · No verified English nameCXHL2200798 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2022/10/15Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2200305 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2022/10/15Import · Class 1 BMS-986278-01片 · No verified English nameJXHL2200304 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2022/10/15Import · Class 2.4 Odevixibat 胶囊 · No verified English nameJXHL2200303 Albireo AB; Syneos Health (Beijing) Inc.Ltd
2022/10/15Import · Class 2.4 Odevixibat 胶囊 · No verified English nameJXHL2200302 Albireo AB; Syneos Health (Beijing) Inc.Ltd
2022/10/15Import · Class 2.4 Odevixibat 胶囊 · No verified English nameJXHL2200301 Albireo AB; Syneos Health (Beijing) Inc.Ltd
2022/10/15Import · Class 2.4 Odevixibat 胶囊 · No verified English nameJXHL2200300 Albireo AB; Syneos Health (Beijing) Inc.Ltd
2022/10/15Generic · Class 3 Potassium Chloride GranulesCYHS2201746 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2022/10/15Generic · Class 3 Potassium Chloride GranulesCYHS2201744 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2022/10/15Generic · Class 3 美洛昔康纳晶注射液 · No verified English nameCYHL2200092 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/10/14Import · Class 1 ChAdOx1-HBV · No verified English nameJXSL2200183 Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd.
2022/10/14Import · Class 1 MVA-HBV · No verified English nameJXSL2200182 Vaccitech (UK) Ltd; Novotech Clinical Services (Shanghai) Co. Ltd.
2022/10/14Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2201741 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/10/14Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2201740 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/10/14Generic · Class 3 复方醋酸钠林格注射液 · No verified English nameCYHS2201739 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/10/14Generic · Class 3 Peramivir InjectionCYHS2201738 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2022/10/14Generic · Class 3 Cladribine InjectionCYHS2201733 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2022/10/14Generic · Class 3 环孢素滴眼液 · No verified English nameCYHL2200091 Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized
2022/10/14Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2200090 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2022/10/14Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2200089 Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized
2022/10/14New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2200083 Fu Xing Ya Li Feng (Da Lian) Biopharmaceutical Co., Ltd. romanized
2022/10/14New drug · Class 1 PM8002注射液 · No verified English nameCXSL2200516 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/10/14New drug · Class 1 TB-B002D注射液 · No verified English nameCXHL2200797 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2022/10/14New drug · Class 1 TB-B002D注射液 · No verified English nameCXHL2200796 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2022/10/14New drug · Class 2.2 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHL2200795 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/10/14New drug · Class 1 [177Lu]Lu-XT033注射液 · No verified English nameCXHL2200794 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2022/10/13Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2200181 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/13Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2200180 Janssen Research & Development, LLC; Johnson & Johnson (China) Investment Ltd.
2022/10/13Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2201730 Yang Zi Jiang Pharma Group Shanghai Hai Ni Pharma Co., Ltd. romanized

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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