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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 13 August 2025 and 19 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 80 drug names.

2025/08/13 – 2025/08/19

Period
2025/08/13 to 2025/08/19, 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
377
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
106

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

377filings, 118 of them generic

By application type

Application typeFilings
Supplement143
Generic118
New drug77
Import21
Unspecified15
Import re-registration3

By drug type

Drug typeFilings
Chemical drug250
Therapeutic biologic63
TCM53
Biologic6
Prophylactic biologic5

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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2卡格列净二甲双胍缓释片 · No verified English name415
3瑞维那新吸入溶液 · No verified English name3353
4Bifonazole Solution3315
5Baricitinib Tablets3232
6Trazodone Hydrochloride Sustained-release Tablets3220
7中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name317
8中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name317
9Lactulose Oral Solution3134
10Ruxolitinib Phosphate Tablets3127

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB940
2Qilu Pharmaceutical Co., Ltd.843
3Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized730
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized630
5Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized626
6Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
7Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
8BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED430
9Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized434
10Bristol-Myers Squibb Pharma EEIG420

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

136 this week

AcceptedDrugApplicants
2025/08/19Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503045 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503040 Le Pu Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503039 Le Pu Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503038 Le Pu Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503037 Le Pu Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 Pralidoxime Chloride For InjectionCYHS2503035 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2025/08/19Generic · Class 3 Bifonazole SolutionCYHS2503029 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/08/19Generic · Class 3 Polaprezinc GranulesCYHS2503026 Beijing Han Mei Medicines Co., Ltd. romanized
2025/08/19Generic · Class 3 Acetylcysteine GranulesCYHS2503020 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized
2025/08/19New drug · Class 1.1 小儿连花清感颗粒 · No verified English nameCXZS2500034 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/08/19New drug · Class 2.1; 2.3 盘龙七凝胶贴膏 · No verified English nameCXZL2500066 Shaanxi Pan Long Pharma Group Co., Ltd. romanized
2025/08/19New drug · Class 1 GKL-006RTU注射液 · No verified English nameCXSL2500721 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2025/08/19New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2500720 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/08/19New drug · Class 2.2 重组人血小板生成素注射液 · No verified English nameCXSL2500719 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/08/19New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500718 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 注射用3H-10000 · No verified English nameCXSL2500717 Si Kang Rui Qi (Shanghai) Pharma Co., Ltd. romanized
2025/08/19New drug · Class 1 HCB101注射液 · No verified English nameCXSL2500716 Guangzhou Han Ke Bio Co., Ltd. romanized
2025/08/19New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500715 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500714 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 注射用SHR-9839 (sc) · No verified English nameCXSL2500713 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500712 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2025/08/19New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500711 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2025/08/19New drug · Class 1.3 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) · No verified English nameCXSL2500710 Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Huan Ke (Hebei) Bio Technology Co., Ltd. romanized
2025/08/19New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHS2500096 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500876 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 HRS-7058片 · No verified English nameCXHL2500875 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500874 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2500873 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/08/19New drug · Class 1 CG-7321胶囊 · No verified English nameCXHL2500872 Name not romanized
2025/08/19New drug · Class 1 CG-7321胶囊 · No verified English nameCXHL2500871 Name not romanized

106 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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