YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 383 drug applications between 3 May 2026 and 9 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 35 drug names.

2026/05/03 – 2026/05/09

Period
2026/05/03 to 2026/05/09, 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
383
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
89

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

383filings, 45 of them generic

By application type

Application typeFilings
Supplement224
New drug55
Generic45
Import39
Unspecified14
Import re-registration6

By drug type

Drug typeFilings
Chemical drug173
TCM137
Therapeutic biologic61
Biologic9
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

35 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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB2130
2Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
3Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized980
4Qilu Pharmaceutical Co., Ltd.831
5Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
6Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
7Pfizer Inc.540
8Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized540
9Novo Nordisk A/S440
10Roche Pharma (Schweiz) AG430

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

98 this week

AcceptedDrugApplicants
2026/05/09Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600041 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/05/09Import · Class 2.2 德莫奇单抗注射液 · No verified English nameJXSL2600114 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2026/05/09Import · Class 2.2 德莫奇单抗注射液 · No verified English nameJXSL2600113 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2026/05/09Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSL2600112 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/05/09Import · Class 1 AZD2265 · No verified English nameJXHL2600162 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600161 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600160 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600159 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Import · Class 1 AZD9574 · No verified English nameJXHL2600158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/09Generic · Class 3 Acetylcysteine InjectionCYHS2601066 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2026/05/09Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2601064 Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized
2026/05/09Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601058 Anhui Huan Qiu Pharma Co., Ltd. romanized
2026/05/09Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2601053 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized
2026/05/09Generic · Class 3 阿普昔腾坦片 · No verified English nameCYHL2600058 Qilu Pharmaceutical Co., Ltd.
2026/05/09New drug · Class 1.1 張其鋒百寳丹胶囊 · No verified English nameCXZL2600041 Sen Lin Sheng Tai Nong Ye (Liao Cheng) Co., Ltd. romanized
2026/05/09New drug · Class 1.1 芪黄正气颗粒 · No verified English nameCXZL2600040 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2026/05/09New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600080 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/09New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600079 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/09New drug · Class 1 注射用AX-023(冻干) · No verified English nameCXSL2600488 Beijing An Xin Huai De Bio Technology Co., Ltd. romanized
2026/05/09New drug · Class 1.2 RG003-02注射液 · No verified English nameCXSL2600487 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/05/09New drug · Class 1 SKB575(HBM7575)注射液 · No verified English nameCXSL2600486 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized; Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/09New drug · Class 1 MWN110注射液 · No verified English nameCXSL2600485 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2026/05/09New drug · Class 1 注射用IMW-1001 · No verified English nameCXSL2600484 Long Qi Biopharmaceutical (Hangzhou) Co., Ltd. romanized
2026/05/09New drug · Class 1.3 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600480 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/05/09New drug · Class 1 QLS1403片 · No verified English nameCXHL2600546 Qilu Pharmaceutical Co., Ltd.
2026/05/09New drug · Class 1 QLS1403片 · No verified English nameCXHL2600545 Qilu Pharmaceutical Co., Ltd.
2026/05/09New drug · Class 1 QLS1403片 · No verified English nameCXHL2600544 Qilu Pharmaceutical Co., Ltd.
2026/05/09New drug · Class 1 CS0159片 · No verified English nameCXHL2600543 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/05/09New drug · Class 1 TB-D004C注射液 · No verified English nameCXHL2600540 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2026/05/09New drug · Class 1 TB-D004C注射液 · No verified English nameCXHL2600539 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized

68 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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