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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 18 December 2024 and 24 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 76 drug names.

2024/12/18 – 2024/12/24

Period
2024/12/18 to 2024/12/24, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
3

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

394filings, 111 of them generic

By application type

Application typeFilings
Supplement178
Generic111
New drug66
Import21
Unspecified12
Import re-registration6

By drug type

Drug typeFilings
Chemical drug269
TCM71
Therapeutic biologic49
Biologic4
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Safinamide Methansulfonate Tablets6320
2Vonoprazan Fumarate Tablets4260
3Tadalafil Tablets3123
4Lidocaine and Prilocaine Cream3124
5Sildenafil Citrate Tablets3112
6Alfacalcidol Soft Capsules319
7阿贝西利片 · No verified English name312
8Diquafosol Sodium Eye Drops225
9Bumetanide Injection2213
10Bisoprolol Fumarate and Amlodipine Besylate Tablets229

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

238 companies with new acceptances; top 10 listed

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

122 this week

AcceptedDrugApplicants
2024/12/24Import · Class 1 Tiragolumab注射液 · No verified English nameJXSL2400246 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2024/12/24Generic · Class 3 Bumetanide InjectionCYHS2404492 Henan Qun Yi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2024/12/24Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2404487 Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Yu Xin Pharma Co., Ltd. romanized
2024/12/24Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2404486 Hubei Guang Ji Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized
2024/12/24Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2404473 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2024/12/24Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2404472 Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized
2024/12/24Generic · Class 3 Minoxidil LinimentCYHS2404470 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2024/12/24Generic · Class 3 Minoxidil LinimentCYHS2404469 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2024/12/24Generic · Class 3 Hydrotalcite SuspensionCYHS2404466 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/12/24Generic · Class 3 Ceftaroline Fosamil for InjectionCYHL2400268 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/12/24Generic · Class 3 Ceftaroline Fosamil for InjectionCYHL2400267 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/12/24New drug · Class 1.1 连参更年颗粒 · No verified English nameCXZL2400095 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2024/12/24New drug · Class 1 注射用YB-01 · No verified English nameCXSL2400895 Yuan Ben (Zhuhai Heng Qin) Bio Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400894 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/12/24New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2400893 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/12/24New drug · Class 1 SENL103自体T细胞注射液 · No verified English nameCXSL2400892 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 培来加南喷雾剂 · No verified English nameCXHS2400130 Pu Lai Pharmaceuticals (Jiangsu) Co., Ltd. romanized
2024/12/24New drug · Class 2.2 LD111118 · No verified English nameCXHL2401439 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/12/24New drug · Class 1 注射用iSAP-0909 · No verified English nameCXHL2401438 Ai Sai Pu (Beijing) Bio Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 HS-10370片 · No verified English nameCXHL2401437 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/24New drug · Class 2.2; 2.4 GRK-007 鼻喷雾剂 · No verified English nameCXHL2401436 Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/24New drug · Class 2.2; 2.4 GRK-007 鼻喷雾剂 · No verified English nameCXHL2401435 Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 WS-0101溶液 · No verified English nameCXHL2401434 Name not romanized
2024/12/24New drug · Class 1 SWA1211片 · No verified English nameCXHL2401433 Beijing Wang Shi Zhi Hui Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 SWA1211片 · No verified English nameCXHL2401432 Beijing Wang Shi Zhi Hui Technology Co., Ltd. romanized
2024/12/24New drug · Class 1 ZD526鼻喷雾剂 · No verified English nameCXHL2401431 Hangzhou Zhi He Dan Gu Biopharmaceuticals Co., Ltd. romanized
2024/12/24New drug · Class 1 HL-1186片 · No verified English nameCXHL2401430 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/12/23Generic · Class 3 Metaraminol Tartrate InjectionCYHS2404463 Henan Qun Yi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2024/12/23Generic · Class 3 Pregabalin Oral SolutionCYHS2404462 Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized
2024/12/23New drug · Class 1 IBR854细胞注射液 · No verified English nameCXSL2400891 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized

92 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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