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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 7 August 2025 and 13 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 77 drug names.

2025/08/07 – 2025/08/13

Period
2025/08/07 to 2025/08/13, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
109

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, 118 of them generic

By application type

Application typeFilings
Supplement177
Generic118
New drug64
Import16
Unspecified11
Import re-registration8

By drug type

Drug typeFilings
Chemical drug258
Therapeutic biologic64
TCM63
Biologic5
Prophylactic biologic4

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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets4235
2苯磺酸左氨氯地平片 · No verified English name4245
3替尔泊肽注射液 · No verified English name4122
4瑞维那新吸入溶液 · No verified English name3353
5Baricitinib Tablets3232
6Sacubitril Valsartan Sodium Tablets3270
7Finerenone Tablets3269
8中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
9中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
10中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized18612
2Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized1560
3Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized1080
4Hunan Ke Lun Pharmaceutical Co., Ltd. romanized754
5Henan Ling Rui Pharmaceutical Co., Ltd. romanized640
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
7Shanxi Hua Kang Pharma Co., Ltd. romanized550
8Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized540
9Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized520
10Terumo Corporation Kofu Factory510

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

128 this week

AcceptedDrugApplicants
2025/08/13Import · Class 2.2 DS-1062a · No verified English nameJXSL2500147 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/08/13Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2500146 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/08/13Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2500145 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/08/13Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500216 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/13Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500215 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/13Import · Class 1 乙磺酸LY4066434片 · No verified English nameJXHL2500214 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/13Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2502957 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502955 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502954 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502953 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502952 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502951 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502950 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/13Generic · Class 3 Phosribbon combination granulesCYHS2502947 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/08/13Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2502944 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/08/13Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2502943 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/08/13New drug · Class 3.2 贝伐珠单抗眼内注射液 · No verified English nameCXSS2500082 Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/08/13New drug · Class 3.3 QL2302注射液 · No verified English nameCXSL2500693 Qilu Pharmaceutical Co., Ltd.
2025/08/13New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500692 Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized
2025/08/13New drug · Class 2.4; 2.2 PRT-062鼻喷雾剂 · No verified English nameCXHL2500838 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/08/13New drug · Class 2.4; 2.2 PRT-062鼻喷雾剂 · No verified English nameCXHL2500837 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2025/08/12Import · Class 2.1 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500108 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2025/08/12Import · Class 1 注射用SAR446523 · No verified English nameJXSL2500144 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/08/12Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2502936 Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502930 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502929 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502928 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/08/12Generic · Class 3 磷/碳酸氢钠血滤置换液(4mmol/L钾、1.25mmol/L钙) · No verified English nameCYHS2502922 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/08/12Generic · Class 3 Peramivir InjectionCYHS2502916 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2025/08/12Generic · Class 3 甲磺酸酚妥拉明滴眼液 · No verified English nameCYHL2500143 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized

98 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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