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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 414 drug applications between 28 August 2026 and 3 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 44 drug names.

2026/08/28 – 2026/09/03

Period
2026/08/28 to 2026/09/03, 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
414
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
304

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

414filings, 58 of them generic

By application type

Application typeFilings
Supplement234
New drug73
Generic58
Import38
Import re-registration9
Unspecified2

By drug type

Drug typeFilings
Chemical drug191
TCM140
Therapeutic biologic79
Prophylactic biologic4

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

44 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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Inc.920
2Gan Li Pharma Shandong Co., Ltd. romanized810
3Changchun Jin Sai Pharma Co., Ltd. romanized720
4Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized660
5Novartis Pharma AG640
6Pfizer Inc.640
7F. Hoffmann-La Roche Ltd610
8Beijing Kang Di Ni Pharma Co., Ltd. romanized550
9Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized550
10Novo Nordisk A/S510

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

128 this week

AcceptedDrugApplicants
2026/09/03Import · Class 1 伐米奇拜单抗注射液 · No verified English nameJXSS2600089 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/09/03Import · Class 3.1 西妥昔单抗注射液 · No verified English nameJXSS2600088 Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd.
2026/09/03Import · Class 1 Budoprutug注射液 · No verified English nameJXSL2600236 Climb Bio Inc.; Beijing Mabworks Biotech Company Limited
2026/09/03Import · Class 1 EDK060 · No verified English nameJXHL2600393 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/03Import · Class 1 verducatib 片 · No verified English nameJXHL2600392 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/09/03Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2602204 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/09/03Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2602201 Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2026/09/03Generic · Class 3 Minoxidil LinimentCYHS2602200 Jiangsu Peng Yao Pharma Co., Ltd. romanized
2026/09/03Generic · Class 3 Minoxidil LinimentCYHS2602199 Jiangsu Peng Yao Pharma Co., Ltd. romanized
2026/09/03Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2602196 Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized
2026/09/03New drug · Class 1.2 RBC067提取物 · No verified English nameCXZL2600086 Sen Rui Pu Sheng Ming Ke Xue Pharma (Hainan) Group Co., Ltd. romanized
2026/09/03New drug · Class 1.2 RBC067凝胶 · No verified English nameCXZL2600085 Sen Rui Pu Sheng Ming Ke Xue Pharma (Hainan) Group Co., Ltd. romanized
2026/09/03New drug · Class 1 BNT3219注射液 · No verified English nameCXSL2600958 Bai Ou En Tai (Zhuhai) Pharmaceuticals Research and Development Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600957 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 1 QLS2416注射液 · No verified English nameCXSL2600956 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/09/03New drug · Class 1 注射用HS-20110 · No verified English nameCXSL2600955 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/09/03New drug · Class 1 ICP-B161注射液 · No verified English nameCXSL2600954 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/09/03New drug · Class 1 HRS-7535片 · No verified English nameCXHS2600125 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 1 HRS-7535片 · No verified English nameCXHS2600124 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 1 注射用RYUC-L-18 · No verified English nameCXHL2601070 Rui Yang (Shanghai) Xin Yao Research and Development Co., Ltd. romanized
2026/09/03New drug · Class 1 注射用RYUC-L-18 · No verified English nameCXHL2601069 Rui Yang (Shanghai) Xin Yao Research and Development Co., Ltd. romanized
2026/09/03New drug · Class 1 KVC-191喷雾剂 · No verified English nameCXHL2601068 Ke Wei Xi (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 1 KVC-191喷雾剂 · No verified English nameCXHL2601067 Ke Wei Xi (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/09/03New drug · Class 2.2 布瑞哌唑口服溶液 · No verified English nameCXHL2601066 Lu Zhou Shi Ren Xin Pharma Co., Ltd. romanized
2026/09/02Import · Class 3.1 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600087 Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd.
2026/09/02Import · Class 3.1 莫妥珠单抗注射液(皮下注射) · No verified English nameJXSS2600086 Roche Registration GmbH; Genentech Inc.; Roche (China) Holding Ltd.
2026/09/02Import · Class 3.4 注射用A型肉毒毒素 · No verified English nameJXSS2600085 CKD Bio Corporation
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600391 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600390 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/09/02Import · Class 1 ABBV-295注射液 · No verified English nameJXHL2600389 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd

98 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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