YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 281 drug applications between 11 July 2022 and 17 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 35 drug names.

2022/07/11 – 2022/07/17

Period
2022/07/11 to 2022/07/17, 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
281
Drugs with new generic filings (by drug name, de-duplicated)
35
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

281filings, 50 of them generic

By application type

Application typeFilings
Supplement148
Generic50
Import45
New drug23
Import re-registration10
Unspecified3
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug218
Therapeutic biologic39
TCM19
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Phloroglucinol Injection442
2Palbociclib Capsules310
3Hydromorphone Hydrochloride Extended-Release Tablets310
4Ruxolitinib Phosphate Tablets3127
5Aripiprazole Orally Disintegrating tablets311
6Aminophylline Injection213
7Dexmedetomidine Hydrochloride Injection210
8Oxytocin Injection218
9Calcium Gluconate in Sodium Chloride Injection215
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

152 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang No.4 Pharmaceutical Co., Ltd.1343
2Actelion Pharmaceuticals Ltd810
3Sichuan Guo Rui Pharma Co., Ltd. romanized720
4Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized720
5Novo Nordisk A/S620
6Eli Lilly and Company610
7LES LABORATOIRES SERVIER530
8Novartis Pharma AG520
9Yi Chang Ren Fu Pharma Co., Ltd. romanized523
10CSL Behring GmbH510

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

89 this week

AcceptedDrugApplicants
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.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200196 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200195 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 2.4 Tirzepatide注射液 · No verified English nameJXHL2200194 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/07/15Import · Class 1 AZD5305 · No verified English nameJXHL2200193 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2022/07/15Import · Class 1 AZD5305 · No verified English nameJXHL2200192 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2022/07/15Import · Class 1 AZD5305 · No verified English nameJXHL2200191 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2022/07/15Import · Class 1 AZD5305 · No verified English nameJXHL2200190 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2022/07/15Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201079 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2022/07/15Generic · Class 3 Aminophylline InjectionCYHS2201076 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/07/15Generic · Class 3 Aminophylline InjectionCYHS2201075 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/07/15Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2201074 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2022/07/15Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2201073 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2022/07/15Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201072 Ling Kang Pharma Group Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/07/15New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2200067 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2022/07/15New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSS2200066 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2022/07/15New drug · Class 1 注射用重组人凝血因子VIIa-Fc融合蛋白 · No verified English nameCXSL2200322 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized
2022/07/15New drug · Class 1 注射用重组人凝血因子VIIa-Fc融合蛋白 · No verified English nameCXSL2200321 Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized
2022/07/14Import · Class 3.1 艾加莫德α注射液 · No verified English nameJXSS2200022 argenx BV; Vetter Pharma-Fertigung GmbH & Co. KG; Zai Lab (Shanghai) Co. Ltd.
2022/07/14Import · Class 1 CAEL-101注射液 · No verified English nameJXSL2200120 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2022/07/14Import · Class 1 CPI-006注射液 · No verified English nameJXSL2200119 Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals Co. Ltd.
2022/07/14Import · Class 1 LTT462 · No verified English nameJXHL2200189 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 LTT462 · No verified English nameJXHL2200188 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/07/14Import · Class 1 TNO155 · No verified English nameJXHL2200187 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

59 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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