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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 222 drug applications between 2 June 2022 and 8 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 20 drug names.

2022/06/02 – 2022/06/08

Period
2022/06/02 to 2022/06/08, 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
222
Drugs with new generic filings (by drug name, de-duplicated)
20
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

222filings, 24 of them generic

By application type

Application typeFilings
Supplement133
New drug30
Generic24
Import21
Unspecified8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug135
Therapeutic biologic44
TCM39
Biologic2
Prophylactic biologic2

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

20 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方聚乙二醇电解质散(Ⅲ) · No verified English name221
2Tandospirone Citrate Tablets212
3Rocuronium Bromide Injection211
4阿普米司特片 · No verified English name213
5复方聚乙二醇电解质散(III) · No verified English name113
6Flurbiprofen Sodium Eye Drops115
7泊沙康唑注射液 · No verified English name111
8Sodium Hyaluronate Eye Drops1130
9Mannitol-S Injection111
10Lenvatinib Mesilate Capsules114

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized2060
2Jilin Rui Long Pharma Co., Ltd. romanized880
3Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized880
4Kai Feng Yu Gang Pharmaceutical Co., Ltd. romanized870
5Novartis Pharma AG630
6Guangxi Ji Min Tang Pharma Co., Ltd. romanized440
7Bristol-Myers Squibb Pharma EEIG410
8Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized330
9Mei Shi Chemical Pharmaceutical Co., Ltd. Nan Tou Factory romanized320
10Qilu Pharmaceutical (Hainan) Co., Ltd321

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

49 this week

AcceptedDrugApplicants
2022/06/08Import · Class 1 PM1016注射液 · No verified English nameJXSL2200073 TILT Biotherapeutics Ltd.; Biotheus Inc.
2022/06/08Import · Class 1 吸入用Ensifentrine混悬液 · No verified English nameJXHL2200133 Verona Pharma plc; Nuance Pharma (Shanghai) Co. Ltd.
2022/06/08New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200251 Qilu Pharmaceutical Co., Ltd.
2022/06/08New drug · Class 1 PM8002注射液 · No verified English nameCXSL2200250 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/06/08New drug · Class 1 重组抗HER2人源化HuA21单克隆抗体注射液 · No verified English nameCXSL2200249 Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized
2022/06/08New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2200361 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2022/06/07Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2200071 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/06/07New drug · Class 1 注射用DB-1305 · No verified English nameCXSL2200248 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/06/07New drug · Class 1 ASKB589注射液 · No verified English nameCXSL2200247 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2022/06/07New drug · Class 1 重组抗EpCAM-CD3抗体注射液 · No verified English nameCXSL2200243 Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2022/06/07New drug · Class 1 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200242 Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized
2022/06/07New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2200239 Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized
2022/06/07New drug · Class 2.2 沙库巴曲缬沙坦钠缓释片 · No verified English nameCXHL2200360 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/06/06Generic · Class 3 Mannitol-S InjectionCYHS2200836 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/06/06New drug · Class 1 伊基仑赛注射液 · No verified English nameCXSS2200055 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2022/06/06New drug · Class 1 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2200246 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2022/06/06New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200245 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized
2022/06/06New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200244 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized
2022/06/06New drug · Class 1 XNW1011胶囊 · No verified English nameCXHL2200359 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2022/06/03Import · Class 1 DS-1062a · No verified English nameJXSL2200072 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2022/06/03Import · Class 2.2 司库奇尤单抗注射液 · No verified English nameJXSL2200070 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2022/06/03Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2200069 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2200068 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200132 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200131 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200130 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 Paltusotine片 · No verified English nameJXHL2200129 Crinetics Pharmaceuticals Inc.; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2022/06/03Import · Class 1 Capivasertib · No verified English nameJXHL2200128 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 Capivasertib · No verified English nameJXHL2200127 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 MRTX849片 · No verified English nameJXHL2200126 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.

19 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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