YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 186 drug applications between 14 April 2021 and 20 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 17 drug names.

2021/04/14 – 2021/04/20

Period
2021/04/14 to 2021/04/20, 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
186
Drugs with new generic filings (by drug name, de-duplicated)
17
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

186filings, 23 of them generic

By application type

Application typeFilings
Supplement115
Generic23
New drug22
Import re-registration12
Import10
Unspecified3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug162
Therapeutic biologic15
TCM5
Prophylactic biologic3
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

17 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Afatinib Dimaleate Tablets322
2Palbociclib Capsules310
3Lacosamide Tablets210
4Pregabalin Capsules2112
5Desloratadine Tablets110
6Tenofovir alafenamide Fumarate Tablets110
7Levofloxacin and Sodium Chloride Injection1114
8布比卡因脂质体注射液 · No verified English name117
9Dutasteride Soft Capsules110
10Leflunomide Tablets111

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

78 companies with new acceptances; top 10 listed

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

32 this week

AcceptedDrugApplicants
2021/04/19Import · Class 1 BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101011 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/04/19Import · Class 1 BRII-835 (VIR-2218) 注射液 · No verified English nameJXHL2101011 Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited
2021/04/19Import · Class 2.2; 2.4 盐酸二甲双胍迟释片 · No verified English nameJXHL2101009 Anji Pharma (US) LLC; Anji Pharma (Shanghai) Limited
2021/04/19New drug · Class 1 BR101注射液 · No verified English nameCXSL2101026 Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2021/04/19New drug · Class 1 SHR7280片 · No verified English nameCXHL2101045 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/19New drug · Class 1 SHR7280片 · No verified English nameCXHL2101044 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/19New drug · Class 1 ICP-033片 · No verified English nameCXHL2101043 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/04/19New drug · Class 1 ICP-033片 · No verified English nameCXHL2101042 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/04/19New drug · Class 1 TQB3820片 · No verified English nameCXHL2101040 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/19New drug · Class 1 TQB3820片 · No verified English nameCXHL2101039 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/04/16Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101069 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2021/04/16Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2101068 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/04/16New drug · Class 1.1 芪连降糖片 · No verified English nameCXZL2101006 Shou Du Yi Ke University Fu Shu Beijing Shi Ji Tan Hospital romanized
2021/04/16New drug · Class 2.3 散风通窍滴丸 · No verified English nameCXZL2101005 Yangtze River Pharmaceutical Group Co., Ltd
2021/04/16New drug · Class 1 GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2101024 Shanghai Ji Bei Bio Technology Co., Ltd. romanized
2021/04/16New drug · Class 1 YR-1702注射液 · No verified English nameCXHL2101038 Yangtze River Pharmaceutical Group Co., Ltd
2021/04/16New drug · Class 2.4 HR19034滴眼液 · No verified English nameCXHL2101037 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/04/16New drug · Class 2.4 HR19034滴眼液 · No verified English nameCXHL2101036 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/04/16New drug · Class 2.2 巯嘌呤咀嚼片 · No verified English nameCXHL2101035 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2021/04/16New drug · Class 2.4 Chidamide TabletsCXHL2100224 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2021/04/15New drug · Class 1 UB-421注射液 · No verified English nameCXSL2101027 Lian Yao (Shanghai) Bio Technology Co., Ltd. romanized
2021/04/15New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101025 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/04/15New drug · Class 1 注射用HRS3658 · No verified English nameCXHL2101034 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2021/04/15New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2101033 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/04/15New drug · Class 1 赛沃替尼片 · No verified English nameCXHL2101032 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/04/15New drug · Class 2.3 阿利沙坦酯吲达帕胺缓释片 · No verified English nameCXHL2101031 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/04/14Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101010 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/04/14Import · Class 1 Efgartigimod注射液 · No verified English nameJXSL2101009 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2021/04/14Import · Class 2.2 Benralizumab注射液 · No verified English nameJXSL2101008 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/04/14Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2101059 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized

2 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.