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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 414 drug applications between 7 December 2024 and 13 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 79 drug names.

2024/12/07 – 2024/12/13

Period
2024/12/07 to 2024/12/13, 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
414
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
5

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

414filings, 115 of them generic

By application type

Application typeFilings
Supplement189
Generic115
New drug77
Import19
Unspecified10
Import re-registration3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug277
TCM72
Therapeutic biologic49
Biologic8
Prophylactic biologic7
In vitro diagnostic reagent1

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
1Vonoprazan Fumarate Tablets14760
2Ambroxol Hydrochloride Oral Solution5146
3Empagliflozin Tablets4218
4Isavuconazonium Sulfate for Injection3315
5醋酸兰瑞肽缓释注射液(预充式) · No verified English name310
6Upadacitinib Sustained-release Tablets2243
7Mupirocin Ointment2230
8Voriconazole Tablets211
9Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
10利伐沙班口崩片 · No verified English name214

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

274 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S920
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized920
3Ya Bao Pharma Group Co., Ltd. romanized660
4Hainan Si Da Pharmaceutical Co., Ltd. romanized515
5Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
6Tong Hua Zheng Yuan Pharma Co., Ltd. romanized440
7Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized432
8Jiangxi Qing Feng Pharma Co., Ltd. romanized430
9Hainan Sai Li Ke Pharma Co., Ltd. romanized430
10Merck Sharp & Dohme B. V.410

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

130 this week

AcceptedDrugApplicants
2024/12/13Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2404337 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/12/13Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2404336 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/12/13Generic · Class 3 Nafamostat Mesilate for InjectionCYHL2400257 Kang Pu Pharma Co., Ltd. romanized
2024/12/13Generic · Class 3 双氯芬酸依泊胺贴 · No verified English nameCYHL2400256 Sichuan Tian Dao Pharmaceutical Co., Ltd. romanized
2024/12/13New drug · Class 1.1 醒脑益智胶囊 · No verified English nameCXZL2400090 Tang Ning Pharmaceuticals Technology (Jinan) Co., Ltd. romanized
2024/12/13New drug · Class 1 YFQLXB-UC01注射液 · No verified English nameCXSL2400857 Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized
2024/12/13New drug · Class 1 BN-1001眼用注射液 · No verified English nameCXSL2400856 Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized
2024/12/13New drug · Class 1 BN-1001眼用注射液 · No verified English nameCXSL2400855 Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized
2024/12/13New drug · Class 1 PH-501片 · No verified English nameCXHL2401372 Yuan Yan Gang (Shanghai) Pharmaceuticals Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized
2024/12/13New drug · Class 1 XS-03片 · No verified English nameCXHL2401371 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2024/12/13New drug · Class 1 XS-03片 · No verified English nameCXHL2401370 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2024/12/13New drug · Class 1 XS-03片 · No verified English nameCXHL2401369 Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized
2024/12/12Import · Class 1 注射用M9140 · No verified English nameJXSL2400236 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2024/12/12Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400291 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/12Import · Class 1 Baxdrostat片 · No verified English nameJXHL2400290 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/12/12Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2400289 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/12Import · Class 1 Olomorasib胶囊 · No verified English nameJXHL2400288 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/12/12Import · Class 1 Sepantronium Bromide注射液 · No verified English nameJXHL2400287 Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd.
2024/12/12Generic · Class 3 Bumetanide InjectionCYHS2404331 Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 Peramivir InjectionCYHS2404329 Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/12/12Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2404328 Beijing Foyou Pharma CO.,LTD
2024/12/12Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2404327 Beijing Foyou Pharma CO.,LTD
2024/12/12Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2404325 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2404324 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2404322 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 Propranolol Hydrochloride TabletsCYHS2404319 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2404316 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 Lidocaine Hydrochloride GelCYHS2404314 Hua Run Shuang He Pharma Co., Ltd. romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized
2024/12/12Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2404313 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2024/12/12Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2404312 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized

100 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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