YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 265 drug applications between 21 February 2021 and 27 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 28 drug names.

2021/02/21 – 2021/02/27

Period
2021/02/21 to 2021/02/27, 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
265
Drugs with new generic filings (by drug name, de-duplicated)
28
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

265filings, 37 of them generic

By application type

Application typeFilings
Supplement127
New drug53
Generic37
Import23
Unspecified15
Import re-registration10

By drug type

Drug typeFilings
Chemical drug205
Therapeutic biologic43
Prophylactic biologic11
TCM5
Biologic1

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Torsemide Injection321
2Fondaparinux Sodium Injection221
3Olanzapine Orally Disintegrating Tablets210
4Quetiapine Fumarate Extended-release Tablets210
5Pregabalin Capsules2112
6Pemetrexed Disodium for Injection214
7Dexmedetomidine Hydrochloride Injection211
8色甘酸钠颗粒 · No verified English name210
9丙酸氟替卡松吸入粉雾剂 · No verified English name111
10Dantrolene Sodium Capsules110

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized840
2Eli Lilly and Company720
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD630
4Bayer Inc.610
5Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized532
6Qilu Pharmaceutical (Hainan) Co., Ltd420
7Fertin Pharma A/S410
8GlaxoSmithKline Biologicals SA410
9NAPP PHARMACEUTICALS LIMITED410
10Novo Nordisk A/S410

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

86 this week

AcceptedDrugApplicants
2021/02/27Import · Class 1 注射用E6201 · No verified English nameJXHL2100064 JS INNOPHARM LIMITED
2021/02/27Generic · Class 3 Fudosteine oral solutionCYHS2100241 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 3.3 LY01015注射液 · No verified English nameCXSL2100076 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/02/27New drug · Class 3.3 LY01015注射液 · No verified English nameCXSL2100075 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/02/27New drug · Class 3.4 托珠单抗注射液 · No verified English nameCXSL2100074 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 AK117注射液 · No verified English nameCXSL2100064 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/02/27New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2100063 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/02/27New drug · Class 1 LP-118片 · No verified English nameCXHL2100148 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 LP-118片 · No verified English nameCXHL2100147 Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100146 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100145 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 ICP-332片 · No verified English nameCXHL2100144 Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/02/27New drug · Class 1 HS-10365胶囊 · No verified English nameCXHL2100143 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/02/27New drug · Class 1 HS-10365胶囊 · No verified English nameCXHL2100142 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/02/27New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2100141 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/02/27New drug · Class 1 JAB-3312胶囊 · No verified English nameCXHL2100140 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/02/26Import · Class 1 Mim8 · No verified English nameJXSL2100032 Novo Nordisk A/S
2021/02/26Import · Class 1 Mim8 · No verified English nameJXSL2100031 Novo Nordisk A/S
2021/02/26Import · Class 1 ALG-000184片 · No verified English nameJXHL2100057 Aligos Therapeutics Inc.
2021/02/26Import · Class 1 ALG-000184片 · No verified English nameJXHL2100056 Aligos Therapeutics Inc.
2021/02/26Import · Class 1 ALG-000184片 · No verified English nameJXHL2100055 Aligos Therapeutics Inc.
2021/02/26New drug · Class 3.3 门冬胰岛素注射液 · No verified English nameCXSS2100025 Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized
2021/02/26New drug · Class 1 重组抗PD-L1和TGF-β双特异性抗体注射液 · No verified English nameCXSL2100073 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2021/02/26New drug · Class 1.2 重组三价轮状病毒亚单位疫苗 · No verified English nameCXSL2100072 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized
2021/02/26New drug · Class 1 HRS8807片 · No verified English nameCXHL2100139 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/26New drug · Class 1 HRS8807片 · No verified English nameCXHL2100138 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/02/25Import · Class 3.1 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100018 GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA
2021/02/25Import · Class 3.1 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100017 GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA
2021/02/25Import · Class 1 Mim8 · No verified English nameJXSL2100034 Novo Nordisk A/S
2021/02/25Import · Class 1 Mim8 · No verified English nameJXSL2100033 Novo Nordisk A/S

56 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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