YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 349 drug applications between 15 January 2025 and 21 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 76 drug names.

2025/01/15 – 2025/01/21

Period
2025/01/15 to 2025/01/21, 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
349
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
8

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

349filings, 108 of them generic

By application type

Application typeFilings
Supplement155
Generic108
New drug56
Import26
Import re-registration4

By drug type

Drug typeFilings
Chemical drug261
TCM49
Therapeutic biologic35
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets6227
2帕拉米韦氯化钠注射液 · No verified English name4217
3Mivacurium Chloride Injection423
4Brexpiprazole Tablets3131
5Ethyl Iosapentate Capsules2227
6Pentoxifylline Modified Release Tablets226
7Isavuconazonium Sulfate for Injection2215
8Tedizolid Phosphate For Injection223
9聚乙二醇钠钾散 · No verified English name223
10Benzbromarone Tablets224

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized16120
2Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized12120
3Anhui Shuang He Pharma Co., Ltd. romanized820
4AstraZeneca AB650
5Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized640
6Fresenius Kabi AB510
7Shandong Qidu Pharmaceutical Co., Ltd.431
8Alexion Pharmaceuticals Inc.420
9Chengdu Rong Sheng Pharma Co., Ltd. romanized420
10Hainan Brilliant Pharmaceutical Co., Ltd.424

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

114 this week

AcceptedDrugApplicants
2025/01/21Import · Class 1 AZD5492 · No verified English nameJXSL2500016 AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd.
2025/01/21Import · Class 1 AZD5492 · No verified English nameJXSL2500015 AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd.
2025/01/21Import · Class 1 AZD2936 · No verified English nameJXSL2500014 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/21Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500013 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/21Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500012 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/21Import · Class 1 Bexicaserin口服溶液 · No verified English nameJXHL2500013 Longboard Pharmaceuticals Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2025/01/21Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2500385 Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 Sildenafil Sitrate For Oral SuspensionCYHS2500378 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2500376 Yan Tai Zheng Fang Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 Azilsartan and Amlodipine TabletsCYHS2500375 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/01/21Generic · Class 3 Epalrestat TabletsCYHS2500372 Shenyang Yong Da Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2500371 Chengdu Yi Lu Rong Yao Drug Technology Co., Ltd. romanized
2025/01/21Generic · Class 3 Potassium Phosphates InjectionCYHS2500370 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 微量元素注射液4-II · No verified English nameCYHS2500368 Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/01/21Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2500367 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 Progesterone InjectionCYHS2500365 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2025/01/21Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2500364 Bai Shi Dun (Hainan) Medical Technology Co., Ltd. romanized; Dong Guan Shi Jin Mei Ji Pharma Co., Ltd. romanized
2025/01/21Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500363 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2025/01/21New drug · Class 3.4 注射用重组人脑利钠肽 · No verified English nameCXSS2500006 Suzhou Lan Ding Biopharmaceutical Co., Ltd. romanized
2025/01/21New drug · Class 2.2 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2500061 Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized
2025/01/21New drug · Class 1 BBM-D101注射液 · No verified English nameCXSL2500060 Xin Zhong Pharmaceuticals Technology (Beijing) Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized; Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized
2025/01/21New drug · Class 2.4 DJ-01注射剂 · No verified English nameCXSL2500059 Suzhou De Jin Biopharmaceutical Co., Ltd. romanized
2025/01/21New drug · Class 1.2 YKYY026注射液 · No verified English nameCXSL2500058 Hangzhou Tian Long Pharma Co., Ltd. romanized
2025/01/21New drug · Class 1 注射用7MW3711 · No verified English nameCXSL2500057 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2025/01/21New drug · Class 3.3 罗莫佐单抗注射液 · No verified English nameCXSL2500056 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized
2025/01/21New drug · Class 1 XS228细胞注射液 · No verified English nameCXSL2500055 Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/01/21New drug · Class 2.2 LJ01003 · No verified English nameCXHS2500009 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2025/01/21New drug · Class 2.2 LJ01003 · No verified English nameCXHS2500008 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2025/01/21New drug · Class 1 硫酸心舒帕莎片 · No verified English nameCXHL2500102 Shandong Qidu Pharmaceutical Co., Ltd.; Shandong University romanized; Shandong University Qi Lu Hospital romanized
2025/01/21New drug · Class 1 硫酸心舒帕莎片 · No verified English nameCXHL2500101 Shandong Qidu Pharmaceutical Co., Ltd.; Shandong University romanized; Shandong University Qi Lu Hospital romanized

84 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.