YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 12 April 2025 and 18 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 64 drug names.

2025/04/12 – 2025/04/18

Period
2025/04/12 to 2025/04/18, 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
307
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
29

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

307filings, 85 of them generic

By application type

Application typeFilings
Supplement139
Generic85
New drug50
Import16
Import re-registration13
Unspecified2
Drug-device combination2

By drug type

Drug typeFilings
Chemical drug217
Therapeutic biologic45
TCM43
Prophylactic biologic2

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

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefotaxime Sodium For Injection4114
2达普司他片 · No verified English name410
3Riociguat Tablets314
4Sacubitril Valsartan Sodium Tablets3170
5Ampicillin Sodium For Injection315
6氟比洛芬凝胶贴膏 · No verified English name2216
7Deferasirox Granules212
8复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
9复方聚乙二醇(3350)电解质散 · No verified English name213
10布美他尼片 · No verified English name218

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB750
2Kowa Company Ltd.510
3Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized510
4Jin Yao Da Ren Tang Group Co., Ltd. Long Shun Rong Pharmaceutical Factory romanized440
5AstraZeneca UK Limited410
6Guangdong Yue He Ze Drug Research Co., Ltd. romanized414
7Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
8Qilu Pharmaceutical (Hainan) Co., Ltd414
9Chongqing Xi Xuan Bio Technology Co., Ltd. romanized330
10Boehringer Ingelheim International GmbH320

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

104 this week

AcceptedDrugApplicants
2025/04/18Generic · Class 3 Cariprazine hydrochloride CapsulesCYHS2501485 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/04/18Generic · Class 3 Cariprazine hydrochloride CapsulesCYHS2501484 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/04/18Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2501482 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/04/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501479 Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized; Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2025/04/18Generic · Class 3 布美他尼片 · No verified English nameCYHS2501478 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/04/18Generic · Class 3 布美他尼片 · No verified English nameCYHS2501477 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2025/04/18Generic · Class 3 镥[177Lu]氧奥曲肽注射液 · No verified English nameCYHS2501474 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Zhongguo Gong Cheng Wu Li Research Institute He Wu Li Yu Chemical Research Institute romanized
2025/04/18New drug · Class 1 ZVS101e注射液 · No verified English nameCXSL2500319 Beijing Zhong Yin Technology Co., Ltd. romanized
2025/04/18New drug · Class 1 AK2024 注射液 · No verified English nameCXSL2500318 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2025/04/18New drug · Class 1 注射用HDM2020 · No verified English nameCXSL2500317 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/04/18New drug · Class 1 玛硒洛沙韦片 · No verified English nameCXHS2500029 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2025/04/18New drug · Class 1 HS387片 · No verified English nameCXHL2500402 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2025/04/18New drug · Class 1 HS387片 · No verified English nameCXHL2500401 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2025/04/18New drug · Class 1 HS387片 · No verified English nameCXHL2500400 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Calcium Carbonate TabletsCYHS2501473 Zhong He Pharmaceuticals (Hubei) Co., Ltd. romanized; Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Bumetanide InjectionCYHS2501471 Shandong Hui Cheng Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2501466 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Promethazine Hydrochloride InjectionCYHS2501465 Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/04/17Generic · Class 3 Indobufen TabletsCYHS2501464 Hunan Qian Jin Xie Li Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2501463 Hebei Hong Xin Tang Pharma Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanized
2025/04/17Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2501461 Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 注射用HY05350 · No verified English nameCXSL2500316 Name not romanized
2025/04/17New drug · Class 1 J002 · No verified English nameCXSL2500315 Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 J002 · No verified English nameCXSL2500314 Wen Zhou Yi Ke University romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 YOLT-101注射液 · No verified English nameCXSL2500313 Yao Tang (Nanjing) Bio Technology Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2025/04/17New drug · Class 1 HF158K1 · No verified English nameCXSL2500312 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 HFK2 · No verified English nameCXSL2500311 Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized
2025/04/17New drug · Class 1 SSS55注射液 · No verified English nameCXSL2500310 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/04/17New drug · Class 1 PTT-621片 · No verified English nameCXHL2500399 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/04/17New drug · Class 1 PTT-621片 · No verified English nameCXHL2500398 Beijing Yan Ming Bio Technology Co., Ltd. romanized

74 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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