YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 475 drug applications between 30 May 2026 and 5 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 73 drug names.

2026/05/30 – 2026/06/05

Period
2026/05/30 to 2026/06/05, 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
475
Drugs with new generic filings (by drug name, de-duplicated)
73
Accepted this week, now under review
151

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

475filings, 108 of them generic

By application type

Application typeFilings
Supplement243
Generic108
New drug78
Import39
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug243
TCM159
Therapeutic biologic69
Biologic2
Prophylactic biologic2

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

73 drugs with new generic filings; top 10 listed

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

288 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized16120
2Eli Lilly and Company1430
3Eli Lilly Nederland B.V.1210
4Novo Nordisk A/S1210
5Chengdu Hua Sen Ao Rui Pharma Co., Ltd. romanized610
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
7Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized550
8Qilu Pharmaceutical Co., Ltd.530
9Jiangsu En Hua Pharma Co., Ltd. romanized520
10Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized440

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

152 this week

AcceptedDrugApplicants
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600139 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600138 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2600137 Medlmmune LLC; AstraZeneca Investment (China) Co. Ltd.
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600136 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600135 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600134 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600133 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600132 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600131 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600130 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600129 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600128 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600127 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/06/05Generic · Class 3 Sivelestat Sodium for InjectionCYHS2601320 Chongqing Lai Mei Pharma Co., Ltd. romanized
2026/06/05Generic · Class 3 维生素K?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2601318 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/06/05Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2601315 Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized
2026/06/05Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601314 Lang Tian Pharma (Hubei) Co., Ltd. romanized
2026/06/05New drug · Class 1.2 注射用AS006 · No verified English nameCXZL2600053 Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/06/05New drug · Class 1.2 AS006 · No verified English nameCXZL2600052 Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/06/05New drug · Class 1 注射用DXC016 · No verified English nameCXSL2600610 Hangzhou Duo Xi Bio Technology Co., Ltd. romanized
2026/06/05New drug · Class 1 EX103注射液 · No verified English nameCXSL2600609 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/05New drug · Class 1 LM101注射液 · No verified English nameCXSL2600608 Beijing Lian Li Zhong Da Medical Technology Co., Ltd. romanized
2026/06/05New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600607 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/05New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600606 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/05New drug · Class 3.3 达雷妥尤单抗注射液(皮下注射) · No verified English nameCXSL2600605 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/06/05New drug · Class 1 HY001N细胞注射液 · No verified English nameCXSL2600604 He Yuan Bio Technology Co., Ltd. romanized; Guangdong He Yuan Biopharmaceuticals Co., Ltd. romanized
2026/06/05New drug · Class 2.3 YZEE03冲洗液 · No verified English nameCXHL2600676 Yi Zhou Hai Yang Bio Technology (Shandong) Co., Ltd. romanized
2026/06/05New drug · Class 1 RZ-520雾化吸入溶液 · No verified English nameCXHL2600675 Ning Kang Xiao Wei Biopharmaceutical (Zhejiang) Co., Ltd. romanized
2026/06/05New drug · Class 1 SYH2092注射液 · No verified English nameCXHL2600674 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/06/05New drug · Class 1 NH302注射液 · No verified English nameCXHL2600673 Jiangsu En Hua Pharma Co., Ltd. romanized

122 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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