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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 3 June 2022 and 9 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 22 drug names.

2022/06/03 – 2022/06/09

Period
2022/06/03 to 2022/06/09, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
22
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

279filings, 34 of them generic

By application type

Application typeFilings
Supplement164
New drug43
Generic34
Import26
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug164
Therapeutic biologic60
TCM48
Prophylactic biologic4
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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Atomoxetine Hydrochloride Capsules716
2Olanzapine Tablets314
3复方聚乙二醇电解质散(Ⅲ) · No verified English name221
4Tandospirone Citrate Tablets212
5Rocuronium Bromide Injection211
6阿普米司特片 · No verified English name213
7复方聚乙二醇电解质散(III) · No verified English name113
8Flurbiprofen Sodium Eye Drops115
9泊沙康唑注射液 · No verified English name111
10Sodium Hyaluronate Eye Drops1130

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

150 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized2060
2Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized1080
3Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized970
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
5Jilin Rui Long Pharma Co., Ltd. romanized770
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.717
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized660
8Novartis Pharma AG620
9Guangxi Ji Min Tang Pharma Co., Ltd. romanized440
10F. Hoffmann-La Roche Ltd430

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

68 this week

AcceptedDrugApplicants
2022/06/09Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2200075 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/09Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2200074 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/09Import · Class 1 CHF6001吸入粉雾剂 · No verified English nameJXHL2200136 Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/06/09Import · Class 1 CHF6001吸入粉雾剂 · No verified English nameJXHL2200135 Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/06/09Import · Class 1 LNP023胶囊 · No verified English nameJXHL2200134 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/06/09Generic · Class 3 芬太尼透皮贴剂(II) · No verified English nameCYHL2200047 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/06/09New drug · Class 3.3 利拉鲁肽注射液 · No verified English nameCXSS2200058 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2022/06/09New drug · Class 3.4 人生长激素注射液 · No verified English nameCXSS2200057 Zhong Shan Wei Ming Hai Ji Biopharmaceuticals Co., Ltd. romanized
2022/06/09New drug · Class 3.4 人生长激素注射液 · No verified English nameCXSS2200056 Zhong Shan Wei Ming Hai Ji Biopharmaceuticals Co., Ltd. romanized
2022/06/09New drug · Class 1 TX103嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200258 Fuzhou Tuo Xin Tian Cheng Bio Technology Co., Ltd. romanized
2022/06/09New drug · Class 1 QL1604注射液 · No verified English nameCXSL2200257 Qilu Pharmaceutical Co., Ltd.
2022/06/09New drug · Class 3.2 阿基仑赛注射液 · No verified English nameCXSL2200256 Fu Xing Kai Te Bio Technology Co., Ltd. romanized
2022/06/09New drug · Class 1 B013注射液 · No verified English nameCXSL2200255 Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized
2022/06/09New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200254 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/06/09New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200253 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/06/09New drug · Class 1 注射用FDA022抗体偶联剂 · No verified English nameCXSL2200252 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2022/06/09New drug · Class 2.2 环孢素眼用凝胶 · No verified English nameCXHS2200033 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2022/06/09New drug · Class 1 HRS-9821吸入混悬液 · No verified English nameCXHL2200365 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/06/09New drug · Class 2.2 纳曲酮植入剂 · No verified English nameCXHL2200364 Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized
2022/06/09New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200363 Le Pu Pharma Co., Ltd. romanized
2022/06/09New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200362 Le Pu Pharma Co., Ltd. romanized
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

38 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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