YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 66 drug applications between 19 September 2021 and 25 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 8 drug names.

2021/09/19 – 2021/09/25

Period
2021/09/19 to 2021/09/25, 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
66
Drugs with new generic filings (by drug name, de-duplicated)
8
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

66filings, 10 of them generic

By application type

Application typeFilings
Supplement44
Generic10
New drug8
Unspecified3
Import1

By drug type

Drug typeFilings
Chemical drug42
TCM16
Therapeutic biologic8

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

8 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension2114
2Felodipine Sustained Release Tablets211
3Levofloxacin Tablets117
4Bromfenac Sodium Eye Drops117
5Regorafenib Tablets113
6Dopamine Hydrochloride Injection113
7Lurasidone Hydrochloride Tablets112
8Abiraterone Acetate Tablets116

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

39 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sai Ling Pharma Technology Group Co., Ltd. romanized980
2Bristol-Myers Squibb Pharma EEIG510
3AstraZeneca AB320
4Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized310
5Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized220
6Jiangxi Di Kang Pharma Co., Ltd. romanized220
7Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized220
8Baxter S.A.210
9Bayer Australia Ltd210
10Hetero Labs Limited210

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

10 this week

AcceptedDrugApplicants
2021/09/23Import · Class 3.1 依奇珠单抗注射液 · No verified English nameJXSS2101023 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2021/09/23Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101767 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2021/09/23New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101340 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101339 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101338 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 注射用SHR-1802 · No verified English nameCXSL2101337 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 重组结核杆菌融合蛋白(D-EC) · No verified English nameCXSL2101336 Kang Zhong (Beijing) Bio Technology Co., Ltd. romanized; Kang Wei Zhong He (Zhong Shan) Bio Pharma Co., Ltd. romanized
2021/09/23New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101494 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/23New drug · Class 1 苹果酸法米替尼胶囊 · No verified English nameCXHL2101493 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/09/22New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2101031 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized

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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