YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 263 drug applications between 27 June 2022 and 3 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 33 drug names.

2022/06/27 – 2022/07/03

Period
2022/06/27 to 2022/07/03, 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
263
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
1

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

263filings, 43 of them generic

By application type

Application typeFilings
Supplement112
New drug63
Generic43
Import20
Import re-registration14
Unspecified11

By drug type

Drug typeFilings
Chemical drug201
Therapeutic biologic36
TCM22
Prophylactic biologic3
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tedizolid Phosphate Tablets331
2Dapoxetine Hydrochloride Tablets3220
3Norepinephrine Bitartrate Injection229
4Levofloxacin Injection211
5Empagliflozin Tablets2118
6盐酸多奈哌齐口崩片 · No verified English name210
7苯磺酸左氨氯地平片 · No verified English name2145
8Atorvastatin Calcium Tablets2124
9Etoricoxib Tablets118
10Pentazocine Injection110

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
1Bayer AG660
2Hebei Wu Luo Pharma Co., Ltd. romanized660
3Hubei Kang Wei Yuan Pharma Co., Ltd. romanized660
4Ren He Yi Kang Group Co., Ltd. romanized640
5Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized610
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
7Suzhou Ya Sheng Pharma Co., Ltd. romanized420
8Novartis Pharma Schweiz AG410
9Pfizer Europe MA EEIG410
10Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized410

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

84 this week

AcceptedDrugApplicants
2022/07/02Import · Class 3.3 贝伐珠单抗注射液 · No verified English nameJXSL2200099 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 3.3 贝伐珠单抗注射液 · No verified English nameJXSL2200098 Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd.
2022/07/02Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200095 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/02New drug · Class 1 BA1106注射液 · No verified English nameCXSL2200307 Shandong Bo An Bio Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 LTC004 · No verified English nameCXSL2200306 Beijing Zhi Dao Bio Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 注射用低分子量岩藻糖化糖胺聚糖钠 · No verified English nameCXSL2200305 Mu Dan Jiang You Bo Pharma Co., Ltd. romanized
2022/07/02New drug · Class 1 靶向GPC3嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200304 Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized
2022/07/02New drug · Class 1 AK119注射液 · No verified English nameCXSL2200296 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200463 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200462 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 JBPOS0101胶囊 · No verified English nameCXHL2200461 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200460 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200459 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 GW201片 · No verified English nameCXHL2200458 Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/07/02New drug · Class 1 EVER001胶囊 · No verified English nameCXHL2200454 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2022/06/30Generic · Class 3 Nicergoline TabletsCYHS2200980 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200978 Changchun Hai Yue Pharma Co., Ltd. romanized
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200977 Changchun Hai Yue Pharma Co., Ltd. romanized
2022/06/30Generic · Class 3 Peramivir InjectionCYHS2200976 Suzhou Ai Mei Jin Pharmaceutical Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2022/06/30Generic · Class 3 Anagrelide Hydrochloride CapsulesCYHS2200937 Heilongjiang Tian Hong Pharma Co., Ltd. romanized
2022/06/30New drug · Class 1 RY_SW01细胞注射液 · No verified English nameCXSL2200303 Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized
2022/06/30New drug · Class 1 KY-0118 注射剂 · No verified English nameCXSL2200302 Shanghai Ke Yi Pharma Technology Co., Ltd. romanized
2022/06/30New drug · Class 1 注射用贺普拉肽 · No verified English nameCXHL2200457 Shanghai He Pu Pharma Co., Ltd. romanized
2022/06/29Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200097 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/29Import · Class 1 FT-001注射液 · No verified English nameJXSL2200096 Frontera Therapeutics Inc.; Suzhou Frontera Therapeutics Co. Ltd.
2022/06/29Import · Class 1 BIIB122 · No verified English nameJXHL2200167 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/06/29Import · Class 2.4 Tazemetostat Hydrobromide片 · No verified English nameJXHL2200166 HUTCHMED (Hong Kong) Limited; HUTCHMED Limited
2022/06/29Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2200969 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/06/29New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSS2200062 Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized
2022/06/29New drug · Class 2.6 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200300 Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized

54 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.