YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 508 drug applications between 10 June 2026 and 16 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 57 drug names.

2026/06/10 – 2026/06/16

Period
2026/06/10 to 2026/06/16, 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
508
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
142

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

508filings, 80 of them generic

By application type

Application typeFilings
Supplement304
Generic80
New drug79
Import26
Import re-registration12
Unspecified7

By drug type

Drug typeFilings
Chemical drug272
TCM166
Therapeutic biologic65
Prophylactic biologic3
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

57 drugs with new generic filings; top 10 listed

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

298 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized1090
2Eli Lilly and Company830
3Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized770
4Pfizer Inc.630
5Amgen Inc.610
6Bao Tou Zhong Yao Co., Ltd. romanized550
7Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized550
8Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
9Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520

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

138 this week

AcceptedDrugApplicants
2026/06/16Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600053 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/06/16Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600052 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D(China)Co. Ltd
2026/06/16Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600142 Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd.
2026/06/16Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHS2600065 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/16Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHS2600064 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/16Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHS2600063 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/16Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHS2600062 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/16Import · Class 2.4 那米司特片 · No verified English nameJXHL2600221 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/06/16Import · Class 2.4 那米司特片 · No verified English nameJXHL2600220 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/06/16Import · Class 1 YMI024 · No verified English nameJXHL2600219 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/06/16Generic · Class 3 Propranolol hydrochloride oral solutionCYHS2601427 Da Wei (Anhui) Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2026/06/16Generic · Class 3 乳酸维持液含葡萄糖10% · No verified English nameCYHS2601426 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized
2026/06/16Generic · Class 3 复方聚乙二醇(3350)电解质维C散 · No verified English nameCYHS2601425 Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized
2026/06/16Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601423 NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2026/06/16Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601421 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2026/06/16Generic · Class 3 Compound Paracetamol and Vitamin C Effervescent TabletsCYHS2601420 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/06/16Generic · Class 3 Magnesium Sulfate InjectionCYHS2601419 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2026/06/16New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2600645 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/06/16New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2600644 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/06/16New drug · Class 1.2 重组轮状病毒亚单位疫苗(大肠杆菌) · No verified English nameCXSL2600643 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2026/06/16New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600642 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2026/06/16New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600641 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/06/16New drug · Class 1 注射用YL242 · No verified English nameCXSL2600640 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/06/16New drug · Class 1 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2600639 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2026/06/16New drug · Class 2.3 缬沙坦马来酸左氨氯地平片 · No verified English nameCXHS2600090 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/06/16New drug · Class 1 镥[177Lu]JH020002注射液 · No verified English nameCXHL2600726 Jing He Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Jing He Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/16New drug · Class 1 GFH276片 · No verified English nameCXHL2600725 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/16New drug · Class 2.1; 2.4 SAL0120CSA片 · No verified English nameCXHL2600724 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/06/16New drug · Class 2.1; 2.4 SAL0120CSA片 · No verified English nameCXHL2600723 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/06/16New drug · Class 2.1; 2.4 SAL0120CSA片 · No verified English nameCXHL2600722 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

108 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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