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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 344 drug applications between 19 April 2025 and 25 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 74 drug names.

2025/04/19 – 2025/04/25

Period
2025/04/19 to 2025/04/25, 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
344
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
44

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

344filings, 93 of them generic

By application type

Application typeFilings
Supplement173
Generic93
New drug34
Import33
Unspecified7
Import re-registration3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug250
TCM63
Therapeutic biologic26
Prophylactic biologic4
Biologic1

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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pemafibrate Tablets3323
2Ruxolitinib Phosphate Tablets3127
3草酸艾司西酞普兰口服溶液 · No verified English name2211
4蒙脱石混悬液 · No verified English name2231
5Tacrolimus Ointment216
6Diclofenac Sodium Sustained Release Tablets2110
7Dimethyl Fumarate Delayed-release Capsules210
8Vonoprazan Fumarate Tablets2160
9Tandospirone Citrate Tablets212
10Levobupivacaine Hydrochloride Injection212

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

202 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized16100
2Eli Lilly and Company1420
3Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized880
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.543
6Guangdong Dong Yang Guang Pharma Co., Ltd. romanized520
7Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized441
8Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized440
9Guizhou Bei Bi Qiang Pharma Co., Ltd. romanized440
10M/s Cipla Ltd.430

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

91 this week

AcceptedDrugApplicants
2025/04/25Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2500064 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/04/25Import · Class 2.4 匹妥布替尼片 · No verified English nameJXHL2500102 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/25Import · Class 2.4 匹妥布替尼片 · No verified English nameJXHL2500101 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/25Import · Class 1 BPC2001注射液 · No verified English nameJXHL2500100 BioPhoenix Co. Ltd.; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2025/04/25Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2501576 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/04/25Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2501574 Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2025/04/25Generic · Class 3 Luliconazole CreamCYHS2501571 Hubei Cheng Tian Pharma Co., Ltd. romanized
2025/04/25Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2501570 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/04/25Generic · Class 3 Ferrous Succinate TabletsCYHS2501562 Changchun Hai Yue Pharma Co., Ltd. romanized
2025/04/25Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2501560 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/04/25Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2501557 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2025/04/25Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2501556 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/04/25Generic · Class 3 Fudosteine oral solutionCYHS2501555 Hunan Yi Ge Pharmaceutical Co., Ltd. romanized
2025/04/25Generic · Class 3 Fudosteine oral solutionCYHS2501554 Hunan Yi Ge Pharmaceutical Co., Ltd. romanized
2025/04/25New drug · Class 1.1 化瘀解热颗粒 · No verified English nameCXZL2500025 Sichuan Sheng Zhong Pharmaceuticals Zhuan Hua Yi Xue Center romanized
2025/04/25New drug · Class 1 HSK21542注射液 · No verified English nameCXHL2500410 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/04/25New drug · Class 2.2 石杉碱甲口服溶液 · No verified English nameCXHL2500409 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2025/04/25New drug · Class 2.2 BCM1129 · No verified English nameCXHL2500408 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500099 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500098 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500097 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500096 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500095 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Import · Class 1 Orforglipron片 · No verified English nameJXHL2500094 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/04/24Generic · Class 3 Bifonazole SolutionCYHS2501550 Nanjing Ai De Kai Teng Biopharmaceuticals Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized
2025/04/24Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2501546 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2025/04/24Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHS2501544 Beijing Han Mei Medicines Co., Ltd. romanized
2025/04/24Generic · Class 3 Progesterone InjectionCYHS2501540 Henan Ke Lun Pharma Co., Ltd. romanized
2025/04/24New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSS2500049 Beijing Min Hai Bio Technology Co., Ltd. romanized
2025/04/24New drug · Class 1.2 二价重组呼吸道合胞病毒疫苗(CHO 细胞) · No verified English nameCXSL2500331 Zhejiang San Ye Cao Biopharmaceutical Co., Ltd. romanized

61 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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