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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 194 drug applications between 9 April 2022 and 15 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 33 drug names.

2022/04/09 – 2022/04/15

Period
2022/04/09 to 2022/04/15, 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
194
Drugs with new generic filings (by drug name, de-duplicated)
33
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

194filings, 48 of them generic

By application type

Application typeFilings
Supplement97
Generic48
New drug24
Import14
Import re-registration6
Unspecified4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug149
TCM26
Therapeutic biologic15
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate For Oral Suspension332
2Tadalafil Tablets3123
3Palbociclib Capsules310
4Sitagliptin Phosphate Tablets312
5Rivaroxaban Tablets213
6Levofloxacin Eye Drops2116
7Lacosamide Tablets210
8Flumazenil Injection212
9Omeprazole Sodium for Injection213
10Oxytocin Injection218

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

128 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guizhou Wei Li De Pharmaceutical Co., Ltd. romanized660
2Sanofi -aventis France510
3Zhu Zhou Qian Jin Pharma Co., Ltd. romanized420
4Hainan Pu Li Pharmaceutical Co., Ltd. romanized421
5Boehringer Ingelheim International GmbH410
6Fresenius Kabi Austria GmbH410
7Chengdu Brilliant Pharmaceutical Co., Ltd.323
8Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized323
9Biocon Pharma Limited310
10Blueprint Medicines Corporation310

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

41 this week

AcceptedDrugApplicants
2022/04/15Import · Class 3.1 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2200013 Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd.
2022/04/15Generic · Class 3 Ebastine Oral SolutionCYHS2200600 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2022/04/15Generic · Class 3 Carbocisteine Oral SolutionCYHS2200595 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2022/04/15New drug · Class 2.2 苏龙嘎-4颗粒 · No verified English nameCXZL2200019 Nei Menggu Zi Zhi Qu International Meng Yi Hospital romanized
2022/04/15New drug · Class 1 MN-08片 · No verified English nameCXHL2200237 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2022/04/15New drug · Class 1 HNC664胶囊 · No verified English nameCXHL2200236 Guangzhou Shi Heng Nuo Kang Pharmaceuticals Technology Co., Ltd. romanized
2022/04/15New drug · Class 1 GFH018 片 · No verified English nameCXHL2200235 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/04/15New drug · Class 1 GFH018 片 · No verified English nameCXHL2200234 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/04/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200593 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2022/04/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200589 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2022/04/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200580 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2022/04/14New drug · Class 1.1 ZY002妇科凝胶 · No verified English nameCXZL2200018 Jiangsu Zheng Yang Pharma Co., Ltd. romanized
2022/04/14New drug · Class 1 NRT6003注射液 · No verified English nameCXHL2200233 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2022/04/14New drug · Class 1 68Ga-HX01注射液 · No verified English nameCXHL2200232 He Xin (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized
2022/04/13Import · Class 1 Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2200046 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/04/13Generic · Class 3 Eptifibatide InjectionCYHS2200579 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2022/04/13Generic · Class 3 Flumazenil InjectionCYHS2200578 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/04/13Generic · Class 3 Flumazenil InjectionCYHS2200577 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2022/04/13New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2200169 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2022/04/12Import · Class 1 Tremelimumab · No verified English nameJXSL2200045 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2022/04/12Import · Class 1 JDQ443片 · No verified English nameJXHL2200085 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/04/12Generic · Class 3 洛索洛芬钠细粒剂 · No verified English nameCYHS2200568 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/04/12Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2200564 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 IBI363 · No verified English nameCXSL2200168 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/12New drug · Class 1 注射用DNV3 · No verified English nameCXSL2200167 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 注射用DNV3 · No verified English nameCXSL2200166 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 ZLT-001注射液 · No verified English nameCXSL2200165 Guangzhou Zhi Ling Biopharmaceuticals Co., Ltd. romanized
2022/04/12New drug · Class 1 HRS-7983片 · No verified English nameCXHL2200231 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/04/12New drug · Class 1 HRS-7983片 · No verified English nameCXHL2200230 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/04/11Import · Class 1 CK-3773274片 · No verified English nameJXHL2200084 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd

11 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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