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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 461 drug applications between 6 December 2024 and 12 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 134, covering 84 drug names.

2024/12/06 – 2024/12/12

Period
2024/12/06 to 2024/12/12, 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
461
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
4

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

461filings, 134 of them generic

By application type

Application typeFilings
Supplement210
Generic134
New drug81
Import18
Unspecified14
Import re-registration3
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug309
TCM75
Therapeutic biologic59
Biologic11
Prophylactic biologic5
In vitro diagnostic reagent2

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

84 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets14760
2Lactulose Oral Solution5134
3Empagliflozin Tablets4218
4Roxadustat Capsules4217
5Ambroxol Hydrochloride Oral Solution4146
6Isavuconazonium Sulfate for Injection3315
7Sodium Bicarbonate Injection3210
8醋酸兰瑞肽缓释注射液(预充式) · No verified English name310
9Upadacitinib Sustained-release Tablets2243
10Levocarnitine Oral Solution229

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

285 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1030
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized920
3Jiangxi Qing Feng Pharma Co., Ltd. romanized760
4Ren He Yi Kang Group Co., Ltd. romanized732
5Ya Bao Pharma Group Co., Ltd. romanized660
6Shaanxi Xing Bang Pharma Co., Ltd. romanized515
7Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
8Tong Hua Zheng Yuan Pharma Co., Ltd. romanized440
9Hainan Sai Li Ke Pharma Co., Ltd. romanized430
10Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized420

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

140 this week

AcceptedDrugApplicants
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
2024/12/12Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2404308 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2024/12/12Generic · Class 3 布比卡因脂质体注射液 · No verified English nameCYHS2404307 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2024/12/12Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2400255 Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized
2024/12/12Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2400254 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized
2024/12/12New drug · Class 2.3 淫羊藿素软胶囊 · No verified English nameCXZL2400089 Name not romanized
2024/12/12New drug · Class 1 注射用ALK202 · No verified English nameCXSL2400854 Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized
2024/12/12New drug · Class 1 HC006注射液 · No verified English nameCXSL2400853 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2024/12/12New drug · Class 1 注射用Tye1001 · No verified English nameCXSL2400852 Shenzhen Shi Tai Er Kang Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/12New drug · Class 1 ZX2021注射液 · No verified English nameCXSL2400851 Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized
2024/12/12New drug · Class 2.2; 2.4 马来酸噻吗洛尔凝胶 · No verified English nameCXHS2400129 Beijing Mei Er Sen Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2024/12/12New drug · Class 1 注射用HRS-4029 · No verified English nameCXHL2401368 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2024/12/12New drug · Class 1 SR1375胶囊 · No verified English nameCXHL2401367 Shanghai Sai Mo Luo Bio Technology Co., Ltd. romanized

110 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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