YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 28 June 2025 and 4 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 47 drug names.

2025/06/28 – 2025/07/04

Period
2025/06/28 to 2025/07/04, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
45

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

304filings, 74 of them generic

By application type

Application typeFilings
Supplement166
Generic74
New drug43
Import14
Import re-registration5
Unspecified2

By drug type

Drug typeFilings
Chemical drug187
TCM75
Therapeutic biologic41
Prophylactic 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

47 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

187 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Hua Kang Pharma Co., Ltd. romanized770
2Guangxi Lai Bin Hu Lu Wa Pharma Co., Ltd. romanized660
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
4Heilongjiang Jun An Pharma Group Hong Xiang Pharmaceutical Co., Ltd. romanized550
5Topfond Pharmaceutical Co., Ltd.540
6Lanzhou Tai Bao Pharmaceutical Co., Ltd. romanized530
7Yi Chang Ren Fu Pharma Co., Ltd. romanized530
8Celgene Corporation510
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized430
10Shen Wei Pharma Group Co., Ltd. romanized430

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
2025/07/04Import · Class 2.3 迈之灵片 · No verified English nameJXZL2500002 Aescuven Pharma Deutschland GmbH & Co.KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.
2025/07/04Import · Class 2.3 迈之灵片 · No verified English nameJXZL2500001 Aescuven Pharma Deutschland GmbH & Co. KG; Shenzhen Xingyin Pharmaceutical Co. Ltd.
2025/07/04Import · Class 1 Trontinemab注射液 · No verified English nameJXSL2500119 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2025/07/04Import · Class 1 MK-7240注射液 · No verified English nameJXSL2500118 Merck Sharp & Dohme LLC; Name not romanized
2025/07/04Import · Class 1 GSK3862995B注射液 · No verified English nameJXSL2500117 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2025/07/04Import · Class 1 TAK-360片 · No verified English nameJXHL2500158 Takeda Development Center Americas Inc.
2025/07/04Import · Class 1 TAK-360片 · No verified English nameJXHL2500157 Takeda Development Center Americas Inc.
2025/07/04Import · Class 1 TAK-360片 · No verified English nameJXHL2500156 Takeda Development Center Americas Inc.
2025/07/04Import · Class 1 TAK-360片 · No verified English nameJXHL2500155 Takeda Development Center Americas Inc.
2025/07/04Import · Class 2.2; 2.4 阿布昔替尼口服混悬液 · No verified English nameJXHL2500154 Pfizer Inc.; PFIZER (CHINA) RESEARCH & DEVELOPMENT CO. LTD.
2025/07/04Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2502368 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized
2025/07/04Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2502367 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2025/07/04Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2502365 Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2025/07/04Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502361 Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/07/04New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500538 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/07/04New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500537 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/07/04New drug · Class 1 SHR-1139注射液 · No verified English nameCXSL2500536 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/04New drug · Class 1 IPM514注射液 · No verified English nameCXSL2500535 Beijing Zhen Zhi Yi Xue Technology Co., Ltd. romanized
2025/07/04New drug · Class 1 安瑞替尼胶囊 · No verified English nameCXHS2500070 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized; Beijing Yi Ling Bio Gong Cheng Technology Co., Ltd. romanized
2025/07/04New drug · Class 2.1; 2.2 注射用KLA478 · No verified English nameCXHL2500645 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/04New drug · Class 2.1; 2.2 注射用KLA478 · No verified English nameCXHL2500644 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/04New drug · Class 1 ST114注射液 · No verified English nameCXHL2500643 Hangzhou Rui Ao Biopharmaceuticals Co., Ltd. romanized
2025/07/04New drug · Class 1 注射用ST205 · No verified English nameCXHL2500642 Hangzhou Rui Ao Biopharmaceuticals Co., Ltd. romanized
2025/07/04New drug · Class 2.4 注射用胶原酶 · No verified English nameCXHL2500641 Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanized
2025/07/04New drug · Class 2.1; 2.4 DA002口服溶液 · No verified English nameCXHL2500640 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2025/07/04New drug · Class 2.1; 2.4 DA002口服溶液 · No verified English nameCXHL2500639 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized
2025/07/04New drug · Class 1 P052注射液 · No verified English nameCXHL2500638 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2025/07/04New drug · Class 1 P052注射液 · No verified English nameCXHL2500637 Hui Sheng Biopharmaceutical Co., Ltd. romanized
2025/07/03Generic · Class 3 Peramivir InjectionCYHS2502356 Shandong Yi Kang Pharma Co., Ltd. romanized
2025/07/03Generic · Class 3 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2502352 Jiangsu Jiu Xu Pharma Co., Ltd. romanized

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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