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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 249 drug applications between 9 September 2021 and 15 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 26 drug names.

2021/09/09 – 2021/09/15

Period
2021/09/09 to 2021/09/15, 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
249
Drugs with new generic filings (by drug name, de-duplicated)
26
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

249filings, 38 of them generic

By application type

Application typeFilings
Supplement149
Generic38
New drug36
Import16
Unspecified9
Import re-registration1

By drug type

Drug typeFilings
Chemical drug177
Therapeutic biologic38
TCM26
Prophylactic biologic5
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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Milrinone Injection320
2阿普米司特片 · No verified English name313
3Olmesartan Medoxomil and Hydrochlorothiazide Tablets223
4Pitavastatin Calcium Tablets210
5Ambroxol Hydrochloride Solution For Inhalation2110
6Nilotinib Capsules216
7Amisulpride Tablets210
8Gemcitabine Hydrochloride for Injection211
9Levocetirizine dihydrochloride Oral Solution215
10磷酸奥司他韦干糖浆 · No verified English name210

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

142 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized22210
2Bristol-Myers Squibb Pharma EEIG1020
3Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized770
4Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized610
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
6Eli Lilly Nederland B.V.430
7Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized424
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.422
9CSPC OUYI PHARMACEUTICAL CO., LTD.423
10Bai Ji Shen Zhou (Suzhou) Bio 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

59 this week

AcceptedDrugApplicants
2021/09/15Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSS2101021 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101020 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2101019 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/15Import · Class 2.2; 2.4 布地奈德缓释胶囊 · No verified English nameJXHL2101179 EVEREST MEDICINES (SINGAPORE) PTE. LTD.; Everest Medicines (China) Co. Ltd
2021/09/15Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101735 Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized
2021/09/15Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101734 Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized
2021/09/15New drug · Class 3.4 冻干重组人脑利钠肽 · No verified English nameCXSL2101327 Shijiazhuang Wo Tai Bio Technology Co., Ltd. romanized
2021/09/15New drug · Class 2.4 Pyrotinib Maleate TabletsCXHS2101041 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/15New drug · Class 2.4 Pyrotinib Maleate TabletsCXHS2101040 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/15New drug · Class 1 HZ-H08905片 · No verified English nameCXHL2101480 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized
2021/09/15New drug · Class 1 注射用HRS8179 · No verified English nameCXHL2101473 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/09/15New drug · Class 1 SBK001注射液 · No verified English nameCXHL2101472 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/14Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101109 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/09/14Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101177 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/09/14Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101176 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/09/14Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2101730 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2101729 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Milrinone InjectionCYHS2101728 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/09/14Generic · Class 3 二氟泼尼酯滴眼液 · No verified English nameCYHS2101727 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101719 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2021/09/14New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2101029 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/09/14New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2101028 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/09/14New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2101325 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101479 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101478 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101477 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101476 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101475 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101474 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/13Import · Class 1 IcoSema 注射液 · No verified English nameJXSL2101108 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.

29 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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