YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 514 drug applications between 5 January 2025 and 11 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 213, covering 150 drug names.

2025/01/05 – 2025/01/11

Period
2025/01/05 to 2025/01/11, 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
514
Drugs with new generic filings (by drug name, de-duplicated)
150
Accepted this week, now under review
14

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

514filings, 213 of them generic

By application type

Application typeFilings
Generic213
Supplement189
New drug89
Import13
Unspecified4
Import re-registration4
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug379
TCM70
Therapeutic biologic60
Biologic3
Prophylactic biologic2

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

150 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets6335
2Metformin Hydrochloride And Empagliflozin Extended Release Tablets5212
3Rosuvastatin Calcium and Ezetimibe Tablets (I)449
4Brexpiprazole Tablets4231
5Dapagliflozin Tablets4284
6Crisaborole Ointment3326
7Apalutamide Tablets3318
8Vonoprazan Fumarate Tablets3260
9Levocarnitine Oral Solution329
10Etoricoxib Tablets318

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

298 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized20180
2Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized13120
3Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized710
4Shandong Qidu Pharmaceutical Co., Ltd.665
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.656
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.545
7Qilu Pharmaceutical Co., Ltd.540
8Beijing Foyou Pharma CO.,LTD535
9Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized535
10Takeda Development Center Americas Inc.520

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

179 this week

AcceptedDrugApplicants
2025/01/11Import · Class 1 AZD2936 · No verified English nameJXSL2500007 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/01/11Import · Class 1 TAK-360片 · No verified English nameJXHL2500008 Takeda Development Center Americas Inc.
2025/01/11Import · Class 1 TAK-360片 · No verified English nameJXHL2500007 Takeda Development Center Americas Inc.
2025/01/11Import · Class 1 TAK-360片 · No verified English nameJXHL2500006 Takeda Development Center Americas Inc.
2025/01/11Generic · Class 3 Propranolol Hydrochloride TabletsCYHS2500261 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2025/01/11Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2500260 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/01/11Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2500259 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2025/01/11Generic · Class 3 Potassium Chloride Oral SolutionCYHS2500249 Shandong Qidu Pharmaceutical Co., Ltd.; Shandong Yi Kang Pharma Co., Ltd. romanized
2025/01/11Generic · Class 3 氯雷他定口服溶液 · No verified English nameCYHS2500246 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2025/01/11Generic · Class 3 氯雷他定口服溶液 · No verified English nameCYHS2500245 Hainan Wan Wei Pharmaceutical Co., Ltd. romanized
2025/01/11Generic · Class 3 Indocyaninegreen for InjectionCYHS2500244 Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/01/11Generic · Class 3 Brivaracetam Solution for InjectionCYHS2500242 Jiangxi Ke Rui Pharma Co., Ltd. romanized; Jiangxi Qing Feng Pharma Co., Ltd. romanized
2025/01/11Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHL2500016 Shandong Qidu Pharmaceutical Co., Ltd.
2025/01/11Generic · Class 3 尿素[13C]呼气试验药盒 · No verified English nameCYHL2500015 Fu Rui Sen Bio Technology (Kun Shan) Co., Ltd. romanized
2025/01/11Generic · Class 3 尿素[13C]呼气试验药盒 · No verified English nameCYHL2500014 Fu Rui Sen Bio Technology (Kun Shan) Co., Ltd. romanized
2025/01/11Generic · Class 3 利多卡因软膏 · No verified English nameCYHL2500013 Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/01/11Generic · Class 3 利多卡因软膏 · No verified English nameCYHL2500012 Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized
2025/01/11New drug · Class 3.1 清金化痰颗粒 · No verified English nameCXZS2500001 Shandong Qidu Pharmaceutical Co., Ltd.
2025/01/11New drug · Class 1 ZHB117舌下片 · No verified English nameCXSL2500037 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2025/01/11New drug · Class 1 ZHB117舌下片 · No verified English nameCXSL2500036 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2025/01/11New drug · Class 2.2 布瑞哌唑口服混悬液 · No verified English nameCXHS2500007 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/01/11New drug · Class 1 KHN702片 · No verified English nameCXHL2500057 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/01/11New drug · Class 1 KHN702片 · No verified English nameCXHL2500056 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/01/11New drug · Class 1 KHN702片 · No verified English nameCXHL2500055 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2025/01/11New drug · Class 2.2 XZ157 · No verified English nameCXHL2500054 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/01/10Generic · Class 3 Minoxidil LinimentCYHS2500239 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Minoxidil LinimentCYHS2500238 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Bumetanide InjectionCYHS2500229 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Magnesium Sulfate InjectionCYHS2500228 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/01/10Generic · Class 3 Indocyaninegreen for InjectionCYHS2500221 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

149 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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