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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 22 April 2025 and 28 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 77 drug names.

2025/04/22 – 2025/04/28

Period
2025/04/22 to 2025/04/28, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
43

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

396filings, 97 of them generic

By application type

Application typeFilings
Supplement190
Generic97
New drug61
Import33
Unspecified11
Import re-registration3
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug287
TCM59
Therapeutic biologic40
Prophylactic biologic7
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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pemafibrate Tablets4423
2Vonoprazan Fumarate Tablets3260
3Ruxolitinib Phosphate Tablets3127
4Ferrous Succinate Tablets2220
5草酸艾司西酞普兰口服溶液 · No verified English name2211
6Diclofenac Sodium Sustained Release Tablets2110
7Dimethyl Fumarate Delayed-release Capsules210
8Tandospirone Citrate Tablets212
9注射用头孢唑肟钠 · No verified English name214
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

234 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized16100
2Eli Lilly and Company1420
3Janssen-Cilag International NV940
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
5Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized880
6Guangdong Dong Yang Guang Pharma Co., Ltd. romanized630
7Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized550
8Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized550
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.543
10Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized441

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

122 this week

AcceptedDrugApplicants
2025/04/28Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2500051 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2025/04/28Import · Class 1 VHB937注射用浓溶液 · No verified English nameJXSL2500065 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/04/28Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2501595 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/04/28Generic · Class 3 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2501592 Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/04/28Generic · Class 3 Benzbromarone TabletsCYHS2501591 Zhejiang Jiang Bei Pharma Co., Ltd. romanized
2025/04/28Generic · Class 3 Ferrous Succinate TabletsCYHS2501589 Shaanxi Ju Cheng Biopharmaceuticals Manufacturing Li Cu Jin Center Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/04/28Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2501587 Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized
2025/04/28New drug · Class 2.3 百令胶囊 · No verified English nameCXZL2500027 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/04/28New drug · Class 2.3 百令胶囊 · No verified English nameCXZL2500026 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/04/28New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2500338 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 1 注射用DB-1311 · No verified English nameCXSL2500337 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/04/28New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500336 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500335 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 1 注射用SKB518 · No verified English nameCXSL2500334 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 1 PM8002注射液 · No verified English nameCXSL2500333 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2500332 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/04/28New drug · Class 1 索托克拉片 · No verified English nameCXHS2500042 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 1 索托克拉片 · No verified English nameCXHS2500041 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 1 索托克拉片 · No verified English nameCXHS2500040 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 2.3 左氨氯地平比索洛尔片(Ⅱ) · No verified English nameCXHS2500039 Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized
2025/04/28New drug · Class 2.3 左氨氯地平比索洛尔片(Ⅰ) · No verified English nameCXHS2500038 Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized
2025/04/28New drug · Class 2.2 OLP-210片 · No verified English nameCXHL2500423 Shenzhen Ao Li Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 2.2 OLP-210片 · No verified English nameCXHL2500422 Shenzhen Ao Li Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 2.2 OLP-210片 · No verified English nameCXHL2500421 Shenzhen Ao Li Bio Technology Co., Ltd. romanized
2025/04/28New drug · Class 2.2 雷美替胺双释片 · No verified English nameCXHL2500420 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/04/28New drug · Class 2.4 Apatinib Mesylate TabletsCXHL2500419 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/28New drug · Class 1 ABP-745片 · No verified English nameCXHL2500418 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2025/04/28New drug · Class 1 ABP-745片 · No verified English nameCXHL2500417 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2025/04/28New drug · Class 1 ABP-745片 · No verified English nameCXHL2500416 Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized
2025/04/28New drug · Class 2.2 WS-019 · No verified English nameCXHL2500415 Hubei Wu Shi Pharma Co., Ltd. romanized

92 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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