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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 8 August 2025 and 14 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 131, covering 84 drug names.

2025/08/08 – 2025/08/14

Period
2025/08/08 to 2025/08/14, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
113

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

416filings, 131 of them generic

By application type

Application typeFilings
Supplement172
Generic131
New drug65
Import22
Unspecified19
Import re-registration7

By drug type

Drug typeFilings
Chemical drug280
Therapeutic biologic64
TCM62
Biologic7
Prophylactic biologic3

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
1Sacubitril Valsartan Sodium Tablets6370
2Azilsartan Medoxomil Potassium Tablets4235
3苯磺酸左氨氯地平片 · No verified English name4245
4替尔泊肽注射液 · No verified English name4122
5Baricitinib Tablets3232
6Finerenone Tablets3269
7中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
8中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
9中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
10中性腹膜透析液(碳酸氢盐-G2.5%) · 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

225 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

143 this week

AcceptedDrugApplicants
2025/08/14Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSL2500155 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500154 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500153 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500152 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500151 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 AZD0486 · No verified English nameJXSL2500150 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Import · Class 1 BCD-261注射液 · No verified English nameJXSL2500149 SPH-BIOCAD (HK) LIMITED; SPH-BIOCAD Biopharmaceuticals (SH) Co. Ltd.
2025/08/14Import · Class 1 MEDI5752 · No verified English nameJXSL2500148 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/14Generic · Class 3 Folic Acid TabletsCYHS2502979 Jian Chang Bang Pharma Co., Ltd. romanized; Beijing Si Li An Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 Folic Acid TabletsCYHS2502973 Chengdu Tong De Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 枸橼酸苯海拉明布洛芬片 · No verified English nameCYHS2502972 Hefei En Rui Te Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 Doxycycline Hyclate TabletsCYHS2502969 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/08/14Generic · Class 3 Doxycycline Hyclate TabletsCYHS2502968 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/08/14Generic · Class 3 瑞舒伐他汀钙口崩片 · No verified English nameCYHS2502966 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 瑞舒伐他汀钙口崩片 · No verified English nameCYHS2502965 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2502963 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2025/08/14Generic · Class 3 Isosulfan Blue InjectionCYHL2500146 Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized
2025/08/14Generic · Class 3 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500145 Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized
2025/08/14New drug · Class 1 AZD0901 · No verified English nameCXSL2500694 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2025/08/14New drug · Class 2.3 HY22017胶囊 · No verified English nameCXHS2500095 Changchun Hai Yue Pharma Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2500848 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2500847 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2500846 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2500845 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-2189片 · No verified English nameCXHL2500844 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 1 HRS-2189片 · No verified English nameCXHL2500843 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/14New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500842 Qilu Pharmaceutical Co., Ltd.
2025/08/14New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500841 Qilu Pharmaceutical Co., Ltd.
2025/08/14New drug · Class 2.4 阿贝西利片 · No verified English nameCXHL2500840 Qilu Pharmaceutical Co., Ltd.
2025/08/14New drug · Class 2.2 紫杉醇软胶囊 · No verified English nameCXHL2500839 Mei Ji Biopharmaceuticals (Guangzhou) Co., Ltd. romanized

113 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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