YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 23 November 2025 and 29 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 63 drug names.

2025/11/23 – 2025/11/29

Period
2025/11/23 to 2025/11/29, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
63
Accepted this week, now under review
91

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

351filings, 78 of them generic

By application type

Application typeFilings
Supplement167
Generic78
New drug63
Import25
Unspecified14
Import re-registration4

By drug type

Drug typeFilings
Chemical drug205
TCM86
Therapeutic biologic54
Biologic5
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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name3222
2Paliperidone Palmitate Injection318
3氢溴酸加兰他敏口崩片 · No verified English name313
4Crisaborole Ointment2226
5Tacrolimus Ointment216
6Folic Acid Tablets2112
7Levonorgestrel Tablets215
8Empagliflozin Tablets2118
9Loxoprofen Sodium Patches2130
10Levocetirizine dihydrochloride Oral Solution215

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

211 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized990
2Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized720
3Hunan Ke Lun Pharmaceutical Co., Ltd. romanized721
4Topfond Pharmaceutical Co., Ltd.652
5Shenyang San Sheng Pharmaceutical Co., Ltd. romanized630
6Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized620
7Novo Nordisk A/S610
8Guangdong Lei Yun Shang Pharma Co., Ltd. romanized550
9Xian Le Xi Medical Technology Co., Ltd. romanized550
10Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized540

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

111 this week

AcceptedDrugApplicants
2025/11/29Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500147 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 2.2 利妥昔单抗注射液 · No verified English nameJXSS2500146 Roche Pharma(Schweiz)AG; Roche Diagnostics GmbH
2025/11/29Import · Class 1 JNJ-88545223片 · No verified English nameJXHL2500367 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Import · Class 1 JNJ-88545223片 · No verified English nameJXHL2500366 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2025/11/29Generic · Class 3 Acetylcysteine TabletsCYHS2504115 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/11/29Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2504113 Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2504112 Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 Bromhexine Hydrochloride TabletsCYHS2504110 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2025/11/29Generic · Class 3 复方聚乙二醇电解质散(II) · No verified English nameCYHS2504109 Chongqing Ren Ze Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/11/29Generic · Class 3 ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English nameCYHS2504108 Zhejiang Guo Jing Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2025/11/29New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2501028 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/11/29New drug · Class 1 注射用SSS57 · No verified English nameCXSL2501027 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/29New drug · Class 1 AK139注射液 · No verified English nameCXSL2501026 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 1 AK139注射液 · No verified English nameCXSL2501025 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 1 AK139注射液 · No verified English nameCXSL2501024 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 1 AK139注射液 · No verified English nameCXSL2501023 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 1 AK139注射液 · No verified English nameCXSL2501022 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 1 人自体多克隆调节性T细胞注射液 · No verified English nameCXSL2501020 Shanghai Sai Er Xin Bio Medical Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 注射用SSS57 · No verified English nameCXSL2501019 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/11/29New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2501314 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2501313 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2501312 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2501311 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 RG002C0106注射液 · No verified English nameCXHL2501310 Beijing Xuan Jing Rui Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Xuan Jing Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 注射用SJ001 · No verified English nameCXHL2501309 Shanghai Shi Jiang Bio Technology Co., Ltd. romanized
2025/11/29New drug · Class 1 BEBT-701注射液 · No verified English nameCXHL2501308 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2025/11/29New drug · Class 2.2 DP22001口服乳 · No verified English nameCXHL2501307 Zhongguo Ke College Shanghai Drug Research Institute romanized
2025/11/29New drug · Class 1 UBT251注射液 · No verified English nameCXHL2501306 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2025/11/28Import · Class 1 注射用AZD1163 · No verified English nameJXSL2500231 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/11/28Import · Class 1 注射用MK-1022 · No verified English nameJXSL2500230 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd

81 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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