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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 344 drug applications between 16 January 2025 and 22 January 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 111, covering 79 drug names.

2025/01/16 – 2025/01/22

Period
2025/01/16 to 2025/01/22, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
344
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
13

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

344filings, 111 of them generic

By application type

Application typeFilings
Supplement150
Generic111
New drug57
Import22
Import re-registration4

By drug type

Drug typeFilings
Chemical drug254
TCM44
Therapeutic biologic42
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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets7327
2Mivacurium Chloride Injection423
3Brexpiprazole Tablets3131
4Ethyl Iosapentate Capsules2225
5Piracetam Injection229
6Candesartan Cilexetil and Hydrochlorothiazide Tablets222
7Isavuconazonium Sulfate for Injection2215
8Tedizolid Phosphate For Injection223
9Sodium Thiosulfate Injection222
10聚乙二醇钠钾散 · No verified English name223

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1390
2Anhui Shuang He Pharma Co., Ltd. romanized820
3Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized640
4Anhui Jin Ma Pharma Co., Ltd. romanized550
5AstraZeneca AB540
6Fresenius Kabi AB510
7Bristol-Myers Squibb Company440
8Guizhou Heng He Pharmaceutical Co., Ltd. romanized440
9Hunan Xian Shi Pharmaceutical Co., Ltd. romanized420
10Guangdong Dong Yang Guang Pharma Co., Ltd. romanized410

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

121 this week

AcceptedDrugApplicants
2025/01/22Import · Class 3.1 瑞玛奈珠单抗注射液 · No verified English nameJXSS2500003 TEVA GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; Teva Pharmaceutical Information Consulting (Shanghai) Co. Ltd.
2025/01/22Generic · Class 3 Vigabatrin Powder for Oral SolutionCYHS2500416 Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Raltitrexed for InjectionCYHS2500415 Sichuan Bai Li Pharma Co., Ltd. romanized; Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2500414 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/01/22Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500413 Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized
2025/01/22Generic · Class 3 Tobramycin Sulfate InjectionCYHS2500412 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/01/22Generic · Class 3 Sodium Thiosulfate InjectionCYHS2500410 Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2025/01/22Generic · Class 3 吡格列酮二甲双胍片(15mg/500mg) · No verified English nameCYHS2500407 Ningbo Mei Shu Pharma Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2025/01/22Generic · Class 3 Piracetam InjectionCYHS2500406 Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Sulpiride InjectionCYHS2500405 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Sulpiride InjectionCYHS2500404 Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2500403 Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized
2025/01/22Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500402 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2500401 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2500399 Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized
2025/01/22Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500398 Suzhou Te Rui Pharma Co., Ltd. romanized
2025/01/22Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2500396 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2025/01/22Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2500395 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2025/01/22Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2500394 Gui Lin Nan Yao Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd
2025/01/22Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHL2500021 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2025/01/22New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2500007 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/01/22New drug · Class 1 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500070 Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized
2025/01/22New drug · Class 1 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500069 Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized
2025/01/22New drug · Class 1 依苏帕格鲁肽α注射液 · No verified English nameCXSL2500068 Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized
2025/01/22New drug · Class 1 SHR-4658注射液 · No verified English nameCXSL2500067 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/01/22New drug · Class 1 XS411细胞注射液 · No verified English nameCXSL2500066 Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2025/01/22New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2500065 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2025/01/22New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2500064 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2025/01/22New drug · Class 1 异体人再生胰岛注射液(E-islet 01) · No verified English nameCXSL2500063 Zhi Xin Hao Zheng (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2025/01/22New drug · Class 1 注射用TQB2922 · No verified English nameCXSL2500062 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized

91 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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