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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 301 drug applications between 12 July 2022 and 18 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 37 drug names.

2022/07/12 – 2022/07/18

Period
2022/07/12 to 2022/07/18, 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
301
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
3

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

301filings, 50 of them generic

By application type

Application typeFilings
Supplement168
Generic50
Import39
New drug31
Import re-registration8
Unspecified3
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug238
Therapeutic biologic34
TCM24
Prophylactic biologic4
Biologic1

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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection332
2Palbociclib Capsules310
3Ruxolitinib Phosphate Tablets3127
4Aripiprazole Orally Disintegrating tablets311
5Perampanel Tablets212
6Doxercalciferol Injection211
7Aminophylline Injection213
8Dexmedetomidine Hydrochloride Injection210
9Oxytocin Injection218
10Scopolamine Butylbromide 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

164 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang No.4 Pharmaceutical Co., Ltd.1343
2Actelion Pharmaceuticals Ltd810
3Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized770
4Sichuan Guo Rui Pharma Co., Ltd. romanized720
5Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized720
6AstraZeneca AB620
7Novo Nordisk A/S620
8Eli Lilly and Company610
9Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
10Qingdao Rui Nai Medical Technology Co., Ltd. romanized555

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

93 this week

AcceptedDrugApplicants
2022/07/18Import · Class 3.1 依库珠单抗注射液 · No verified English nameJXSS2200023 Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd
2022/07/18Import · Class 1 Nolasiban分散片 · No verified English nameJXHL2200201 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Import · Class 1 Nolasiban分散片 · No verified English nameJXHL2200200 ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd.
2022/07/18Generic · Class 3 Magnesium Sulfate InjectionCYHS2201096 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/07/18Generic · Class 3 Beraprost Sodium TabletsCYHS2201090 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2022/07/18Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2201088 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/07/18Generic · Class 3 Acotiamide Hydrochloride TabletsCYHS2201087 Beijing Ya Bao Bio Pharma Co., Ltd. romanized
2022/07/18Generic · Class 3 Salbutamol Sulfate injectionCYHS2201078 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/07/18Generic · Class 3 Doxercalciferol InjectionCYHL2200060 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/07/18Generic · Class 3 Doxercalciferol InjectionCYHL2200059 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/07/18Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2200058 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2022/07/18New drug · Class 1 注射用SG1408 · No verified English nameCXSL2200323 Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200514 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200513 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200512 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200511 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200510 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HTMC0435片 · No verified English nameCXHL2200509 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2022/07/18New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200507 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/07/18New drug · Class 1 HZ-A-018胶囊 · No verified English nameCXHL2200506 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2022/07/18New drug · Class 2.4 Nalbuphine Hydrochloride InjectionCXHL2200505 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/18New drug · Class 1 LF0001片 · No verified English nameCXHL2200504 Hangzhou Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2022/07/18New drug · Class 2.2 LJ01005颗粒 · No verified English nameCXHL2200503 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized
2022/07/15Import · Class 1 锆[89Zr]吉伦妥昔单抗注射液 · No verified English nameJXSL2200123 Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd
2022/07/15Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2200122 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/15Import · Class 1 Talquetamab注射液 · No verified English nameJXSL2200121 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/15Import · Class 1 氘可来昔替尼片 · No verified English nameJXHS2200061 Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200199 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200198 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200197 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

63 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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