YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 316 drug applications between 10 September 2021 and 16 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 34 drug names.

2021/09/10 – 2021/09/16

Period
2021/09/10 to 2021/09/16, 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
316
Drugs with new generic filings (by drug name, de-duplicated)
34
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

316filings, 50 of them generic

By application type

Application typeFilings
Supplement185
Generic50
New drug44
Import19
Unspecified11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug224
Therapeutic biologic46
TCM34
Prophylactic biologic9
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

34 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
6Salbutamol Sulfate Inhalation Solution212
7Nilotinib Capsules216
8Amisulpride Tablets210
9Gemcitabine Hydrochloride for Injection211
10Levocetirizine dihydrochloride Oral Solution215

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

182 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized22210
2Bristol-Myers Squibb Pharma EEIG1120
3Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized10100
4Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized610
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized530
6Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized520
7Eli Lilly Nederland B.V.430
8Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized424
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.422
10CSPC OUYI PHARMACEUTICAL CO., LTD.423

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

71 this week

AcceptedDrugApplicants
2021/09/16Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSS2101022 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/09/16Import · Class 1 BCX9930片 · No verified English nameJXHL2101178 BioCryst Pharmaceuticals Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2021/09/16Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2101747 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/09/16Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2101726 Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSS2101030 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 TG103注射液 · No verified English nameCXSL2101330 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101329 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/09/16New drug · Class 1 ZG033注射液 · No verified English nameCXSL2101328 Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized
2021/09/16New drug · Class 2.2 注射用醋酸曲普瑞林微球 · No verified English nameCXHS2101039 Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2021/09/16New drug · Class 2.2 他达拉非口腔速溶膜 · No verified English nameCXHL2101485 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/09/16New drug · Class 1 IMP4297胶囊 · No verified English nameCXHL2101484 Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized
2021/09/16New drug · Class 1 TT-01688-CL片 · No verified English nameCXHL2101483 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
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

41 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.