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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 97 drug applications between 28 April 2021 and 4 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.

2021/04/28 – 2021/05/04

Period
2021/04/28 to 2021/05/04, 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
97
Drugs with new generic filings (by drug name, de-duplicated)
9
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

97filings, 10 of them generic

By application type

Application typeFilings
Supplement63
New drug14
Generic10
Import re-registration5
Import4
Unspecified1

By drug type

Drug typeFilings
Chemical drug63
TCM20
Therapeutic biologic14

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

9 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Alfacalcidol Tablets211
2Diacerein Capsules113
3Tenofovir alafenamide Fumarate Tablets110
4Sodium Hyaluronate Eye Drops1130
5Lenvatinib Mesilate Capsules114
6Tirofiban Hydrochloride Injection110
7Ambroxol Hydrochloride Injection119
8Argatroban Injection112
9Apixaban Tablets113

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

55 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized880
2Hebei Tian Zhi Pharma Co., Ltd. romanized520
3Janssen-Cilag International NV420
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
5Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized330
6Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized330
7Eli Lilly Nederland B.V.320
8Xian Sen Ge Pharma Co., Ltd. romanized320
9Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized310
10Fujian Tian Quan Pharma Co., Ltd. romanized310

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

18 this week

AcceptedDrugApplicants
2021/04/30Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2101020 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2021/04/30Import · Class 1 GSK3196165 注射液 · No verified English nameJXSL2101019 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD
2021/04/30Import · Class 1 RRx-001注射液 · No verified English nameJXHL2101021 EpicentRx Inc.; SciClone Pharmaceuticals (China) Co. Ltd.
2021/04/30New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101051 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/04/30New drug · Class 3.3 重组抗CD20人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2101050 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/04/30New drug · Class 1 IBI360 · No verified English nameCXSL2101044 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/04/30New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101098 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 西奥罗尼胶囊 · No verified English nameCXHL2101097 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101096 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101095 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101094 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2101093 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 ET0038片 · No verified English nameCXHL2101091 Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2021/04/30New drug · Class 1 ET0038片 · No verified English nameCXHL2101090 Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized
2021/04/28Generic · Class 3 Tirofiban Hydrochloride InjectionCYHS2101113 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2021/04/28New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101048 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/28New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101047 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/28New drug · Class 2.2 西罗莫司滴眼液 · No verified English nameCXHL2101092 Fuzhou Hao Ji Pharmaceuticals Technology Development 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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