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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 254 drug applications between 13 March 2022 and 19 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 15 drug names.

2022/03/13 – 2022/03/19

Period
2022/03/13 to 2022/03/19, 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
254
Drugs with new generic filings (by drug name, de-duplicated)
15
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

254filings, 21 of them generic

By application type

Application typeFilings
Supplement169
New drug25
Generic21
Unspecified16
Import14
Import re-registration9

By drug type

Drug typeFilings
Chemical drug182
Therapeutic biologic36
TCM23
Prophylactic biologic7
Biologic6

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

15 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Paliperidone Palmitate Injection318
2Sodium Valproate Concentrated Solution for Injection210
3Ipratropium Bromide Inhalation Solution212
4Pregabalin Capsules2112
5Febuxostat Tablets2112
6布南色林片 · No verified English name110
7Amlodipine Besylate and Atorvastatin Calcium Tablets112
8Nicorandil for Injection111
9Regorafenib Tablets113
10Trimetazidine Dihydrochloride Tablets110

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

132 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized17150
2Jilin Sheng Dou Bang Pharma Co., Ltd. romanized1420
3Zhejiang Dou Bang Pharma Co., Ltd. romanized1220
4Novo Nordisk A/S830
5Sanofi -aventis France710
6Hainan Xu Wo Pharma Co., Ltd. romanized650
7Kyowa Kirin Co. Ltd.610
8PURISYS LLC.550
9Qilu Pharmaceutical Co., Ltd.523
10Celgene Corporation410

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

38 this week

AcceptedDrugApplicants
2022/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200459 Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2022/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2200458 Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2022/03/18New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSL2200132 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized
2022/03/18New drug · Class 1 AND017胶囊 · No verified English nameCXHL2200165 Hangzhou An Dao Pharma Co., Ltd. romanized
2022/03/18New drug · Class 1 AND017胶囊 · No verified English nameCXHL2200164 Hangzhou An Dao Pharma Co., Ltd. romanized
2022/03/18New drug · Class 1 AND017胶囊 · No verified English nameCXHL2200163 Hangzhou An Dao Pharma Co., Ltd. romanized
2022/03/17Import · Class 3.1 注射用Tafasitamab · No verified English nameJXSL2200031 Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd.
2022/03/17Import · Class 2.4 Inclisiran注射液 · No verified English nameJXHL2200061 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd
2022/03/17Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHL2200060 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd.
2022/03/17Import · Class 2.4 Entrectinib胶囊 · No verified English nameJXHL2200059 F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2022/03/17Import · Class 2.4 Entrectinib胶囊 · No verified English nameJXHL2200058 F. Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd.
2022/03/17Generic · Class 3 Minoxidil LinimentCYHS2200456 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/03/17New drug · Class 1.1 小儿香薷颗粒 · No verified English nameCXZL2200015 Yi Li Pharmaceutical Co., Ltd. romanized
2022/03/17New drug · Class 1 MW11注射液 · No verified English nameCXSL2200128 Sheng Sen Biopharmaceutical Co., Ltd. romanized
2022/03/17New drug · Class 1 盐酸凯普拉生注射液 · No verified English nameCXHL2200166 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2022/03/16Generic · Class 3 Nicorandil for InjectionCYHS2200455 Yunnan Xian Shi Pharma Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized
2022/03/16New drug · Class 3.3 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200129 Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2022/03/16New drug · Class 1 注射用ASK0912 · No verified English nameCXHL2200157 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2022/03/15Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2200030 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/03/15Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2200029 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2022/03/15New drug · Class 3.3 23价肺炎球菌多糖疫苗 · No verified English nameCXSS2200028 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2022/03/15New drug · Class 2.2 赛帕利单抗注射液 · No verified English nameCXSS2200025 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2022/03/15New drug · Class 2.2 HY-100209口崩片 · No verified English nameCXHL2200162 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized
2022/03/14Import · Class 1 LY3209590注射液 · No verified English nameJXSL2200027 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/03/14Import · Class 1 AZD2936 · No verified English nameJXSL2200026 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/03/14New drug · Class 2.2 贝那鲁肽注射液 · No verified English nameCXSS2200027 Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized
2022/03/14New drug · Class 2.2 贝那鲁肽注射液 · No verified English nameCXSS2200026 Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized
2022/03/14New drug · Class 1 QX008N注射液 · No verified English nameCXSL2200127 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/03/14New drug · Class 1 QX008N注射液 · No verified English nameCXSL2200126 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/03/14New drug · Class 1 重组人GM-CSF 溶瘤II型单纯疱疹病毒(OH2)注射液(Vero 细胞) · No verified English nameCXSL2200125 Wuhan Bin Hui Bio Technology Co., Ltd. Bio Innovation Yuan Branch romanized

8 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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