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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 377 drug applications between 17 April 2026 and 23 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 46 drug names.

2026/04/17 – 2026/04/23

Period
2026/04/17 to 2026/04/23, 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)
46
Accepted this week, now under review
97

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, 62 of them generic

By application type

Application typeFilings
Supplement208
New drug72
Generic62
Import12
Import re-registration12
Unspecified11

By drug type

Drug typeFilings
Chemical drug184
TCM126
Therapeutic biologic54
Biologic10
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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sitagliptin and Metformin Hydrochloride Extended-release Tablets3212
2阿布昔替尼片 · No verified English name3112
3Edaravone and Dexborneol Concentrated Solution for Injection2234
4Nimodipine Tablets223
5头孢丙烯干混悬剂 · No verified English name212
6Brexpiprazole Orally Disintegrating Tablets2110
7Sacubitril Valsartan Sodium Tablets2170
8Imipenem and Cilastatin Sodium for Injection216
9盐酸氢吗啡酮片 · No verified English name210
10Esomeprazole Magnesium Enteric-Coated Capsules214

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Janssen-Cilag International NV630
2Xinjiang Wei Wu Er Pharma Co., Ltd. romanized630
3Ha Yao Group Bio Gong Cheng Co., Ltd. romanized620
4Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized440
5Fuzhou Min Hai Pharma Co., Ltd. romanized440
6Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440
7Bayer AG430
8Yunnan Bai Yao Group Co., Ltd. romanized430
9Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized434
10Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF)420

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

106 this week

AcceptedDrugApplicants
2026/04/23Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSS2600040 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/23Import · Class 1 Denikitug · No verified English nameJXSL2600101 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/04/23Import · Class 1 Denikitug · No verified English nameJXSL2600100 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/04/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2600937 Hebei Long Hai Pharma Co., Ltd. romanized
2026/04/23Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2600936 Hebei Long Hai Pharma Co., Ltd. romanized
2026/04/23Generic · Class 3 Drotaverine Hydrochloride TabletsCYHS2600928 Jiangxi Yi You Pharma Co., Ltd. romanized
2026/04/23New drug · Class 1.1 清润养目颗粒 · No verified English nameCXZL2600037 Shanghai Pharmaceuticals Group Zhong Yao Research Institute Co., Ltd. romanized
2026/04/23New drug · Class 1 柯美奇拜单抗注射液 · No verified English nameCXSS2600071 Shanghai Mai Ji Pharmaceuticals Co., Ltd. romanized; Ding Kang (Wuhan) Biopharmaceuticals Co., Ltd. romanized
2026/04/23New drug · Class 1 UX-DA003注射液 · No verified English nameCXSL2600438 Shanghai Yue Sai Bio Technology Co., Ltd. romanized
2026/04/23New drug · Class 1 SHR-8203注射液 · No verified English nameCXSL2600437 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/04/23New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2600496 Hainan Kang Zhe Wei Sheng Technology Co., Ltd. romanized
2026/04/23New drug · Class 1 CMS-D017胶囊 · No verified English nameCXHL2600495 Hainan Kang Zhe Wei Sheng Technology Co., Ltd. romanized
2026/04/23New drug · Class 1 S241656片 · No verified English nameCXHL2600494 Shi Wei Ya (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/04/23New drug · Class 1 S241656片 · No verified English nameCXHL2600493 Shi Wei Ya (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/04/23New drug · Class 1 S241656片 · No verified English nameCXHL2600492 Shi Wei Ya (Beijing) Pharmaceuticals Research and Development Co., Ltd. romanized
2026/04/23New drug · Class 1 SNH-118110软胶囊 · No verified English nameCXHL2600487 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2026/04/23New drug · Class 1 SNH-118110软胶囊 · No verified English nameCXHL2600486 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2026/04/23New drug · Class 2.4 甘糖酯片 · No verified English nameCXHL2600485 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized
2026/04/23New drug · Class 2.4 甘糖酯片 · No verified English nameCXHL2600484 Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized
2026/04/22Import · Class 1 AZD2265 · No verified English nameJXHL2600118 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/04/22Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2600923 Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized
2026/04/22Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2600921 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
2026/04/22Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2600920 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2026/04/22Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2600919 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2026/04/22Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2600916 Beijing Hai Jing Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/04/22New drug · Class 1 注射用ZHB130 · No verified English nameCXSL2600436 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/04/22New drug · Class 1 RGL-185注射液 · No verified English nameCXSL2600435 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized
2026/04/22New drug · Class 1 注射用IPN60300 · No verified English nameCXSL2600434 Yi Pu Sheng (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/04/22New drug · Class 1 注射用ESG406 · No verified English nameCXSL2600433 Shanghai Shi Jian Bio Technology Co., Ltd. romanized
2026/04/22New drug · Class 1 注射用IMM2510S · No verified English nameCXSL2600432 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized

76 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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