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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 248 drug applications between 31 March 2025 and 6 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 51 drug names.

2025/03/31 – 2025/04/06

Period
2025/03/31 to 2025/04/06, 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
248
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
19

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

248filings, 68 of them generic

By application type

Application typeFilings
Supplement129
Generic68
New drug32
Import11
Unspecified4
Import re-registration3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug130
TCM74
Therapeutic biologic43
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2维生素B6注射液 · No verified English name2210
3低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name213
4低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name214
5低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name213
6Dexketoprofen Trometamol Tablets210
7Tropicamide Phenylephrine Eye Drops218
8Fusidic Acid Cream2115
9Famciclovir Tablets210
10Sodium Hyaluronate Eye Drops2130

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shaanxi Pan Long Pharma Group Co., Ltd. romanized13110
2Ningbo Tian Yi Pharma Technology Co., Ltd. romanized12612
3Shenyang Dong Xin Pharma Co., Ltd. romanized1060
4Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
5Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized520
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
7Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized440
8Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized420
9Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized410
10Jiangsu En Hua 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

60 this week

AcceptedDrugApplicants
2025/04/03Import · Class 3.1 注射用德曲妥珠单抗 · No verified English nameJXSS2500041 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2500040 AstraZeneca AB; Name not romanized
2025/04/03Import · Class 3.1 本瑞利珠单抗注射液 · No verified English nameJXSS2500039 AstraZeneca AB; Name not romanized
2025/04/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500052 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2500051 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2500050 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 1 Bimagrumab注射液 · No verified English nameJXSL2500049 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/03Import · Class 2.2 注射用佐妥昔单抗 · No verified English nameJXSL2500048 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2025/04/03Generic · Class 3 Diprophylline InjectionCYHS2501299 Shandong Yi Jian Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Acetylcysteine TabletsCYHS2501292 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2501282 Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized; Hubei Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized
2025/04/03Generic · Class 3 Indobufen TabletsCYHS2501281 Zhengzhou Han Dou Pharma Group Co., Ltd. romanized
2025/04/03Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2501277 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/04/03Generic · Class 3 Acetylcysteine InjectionCYHS2501276 Guangdong Jun Kang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/04/03Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2501275 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/04/03Generic · Class 3 Potassium Phosphates InjectionCYHS2501270 Anhui Shuang He Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Ebastine Oral SolutionCYHS2501258 Jiangxi Xin Zheng Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501257 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501255 Jiangsu Yue Xing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2501253 Hubei Hai Mei Na Pharmaceuticals Technology Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/04/03Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501245 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/04/03Generic · Class 3 Dexketoprofen Trometamol TabletsCYHS2501242 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/04/03Generic · Class 3 Dexketoprofen Trometamol TabletsCYHS2501241 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2025/04/03New drug · Class 1.1 芪桂络痹通片 · No verified English nameCXZS2500014 Beijing Yi Ling Pharma Co., Ltd. romanized; Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/04/03New drug · Class 3.1 二冬汤颗粒 · No verified English nameCXZS2500013 Zhejiang Wei Kang Pharma Co., Ltd. romanized
2025/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500043 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2025/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500042 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2025/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500041 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2025/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500040 Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized
2025/04/03New drug · Class 1 Cizutamig注射液 · No verified English nameCXSL2500265 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized

30 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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