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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 197 drug applications between 13 April 2022 and 19 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 32 drug names.

2022/04/13 – 2022/04/19

Period
2022/04/13 to 2022/04/19, 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
197
Drugs with new generic filings (by drug name, de-duplicated)
32
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

197filings, 48 of them generic

By application type

Application typeFilings
Supplement108
Generic48
New drug18
Import13
Import re-registration5
Unspecified4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug142
TCM36
Therapeutic biologic16
Prophylactic biologic3

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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Rivaroxaban Tablets523
2Oseltamivir Phosphate For Oral Suspension332
3Palbociclib Tablets312
4Palbociclib Capsules310
5盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
6Tadalafil Tablets2123
7Levetiracetam Tablets216
8Flumazenil Injection212
9Sugammadex Sodium Injection216
10Acetylcysteine Granules114

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

124 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Tian Fu Kang Da Pharma Group Fu Qing Pharmaceutical Co., Ltd. romanized10100
2Guizhou Wei Li De Pharmaceutical Co., Ltd. romanized660
3Nanchang Bai Ji Pharmaceutical Co., Ltd. romanized650
4Qilu Pharmaceutical Co., Ltd.623
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD523
6Boehringer Ingelheim International GmbH510
7MSN Laboratories Private Limited420
8Zhu Zhou Qian Jin Pharma Co., Ltd. romanized420
9Fresenius Kabi Austria GmbH410
10Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized313

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

39 this week

AcceptedDrugApplicants
2022/04/19Import · Class 1 Pamrevlumab · No verified English nameJXSL2200048 FibroGen Inc; FibroGen (China) Medical Technology Development CO. LTD.
2022/04/19Generic · Class 3 Piperacillin Sodium for InjectionCYHS2200615 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/04/19Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200613 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2022/04/19Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200612 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2022/04/19Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200611 Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2022/04/19Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200606 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2022/04/19New drug · Class 1 镓[68Ga]纳坦重组PD-L1单域抗体注射液 · No verified English nameCXSL2200176 Suzhou Zhi He Biopharmaceuticals Technology Co., Ltd. romanized
2022/04/19New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2200173 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2022/04/19New drug · Class 2.2 RHYK2001 · No verified English nameCXHL2200242 Ren He Yi Kang Group Co., Ltd. romanized
2022/04/19New drug · Class 2.2 氨溴特罗口服滴剂 · No verified English nameCXHL2200222 Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized
2022/04/18Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2200605 Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Kang Pharma Co., Ltd. romanized
2022/04/18Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2200601 Rui Yang Pharmaceutical Co., Ltd. romanized
2022/04/18Generic · Class 3 Palbociclib TabletsCYHS2200586 Qilu Pharmaceutical Co., Ltd.
2022/04/18Generic · Class 3 Palbociclib TabletsCYHS2200585 Qilu Pharmaceutical Co., Ltd.
2022/04/18Generic · Class 3 Palbociclib TabletsCYHS2200584 Qilu Pharmaceutical Co., Ltd.
2022/04/18New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2200172 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2022/04/18New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200241 Qilu Pharmaceutical Co., Ltd.
2022/04/18New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200240 Qilu Pharmaceutical Co., Ltd.
2022/04/18New drug · Class 2.2 磷酸奥司他韦口溶膜 · No verified English nameCXHL2200239 Qilu Pharmaceutical Co., Ltd.
2022/04/18New drug · Class 1 D-2570片 · No verified English nameCXHL2200238 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
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

9 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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