YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 452 drug applications between 30 July 2025 and 5 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 81 drug names.

2025/07/30 – 2025/08/05

Period
2025/07/30 to 2025/08/05, 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
452
Drugs with new generic filings (by drug name, de-duplicated)
81
Accepted this week, now under review
91

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

452filings, 108 of them generic

By application type

Application typeFilings
Supplement215
Generic108
New drug78
Import28
Import re-registration16
Unspecified5
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug279
TCM98
Therapeutic biologic69
Unspecified3
Prophylactic biologic2
Biologic1

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

81 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2Cefditoren Pivoxil Granules3218
3Dapagliflozin Tablets3284
4Finerenone Tablets3269
5Levetiracetam Tablets316
6Brexpiprazole Tablets3131
7Omega-3-acid ethyl ester 90 Soft Capsules2211
8Pemafibrate Tablets2223
9双氯芬酸钠盐酸利多卡因注射液 · No verified English name228
10头孢克肟干混悬剂 · No verified English name223

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

277 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Kelun Pharmaceutical Co., Ltd.1451
2Shanxi Hua Kang Pharma Co., Ltd. romanized1090
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized830
4Qilu Pharmaceutical Co., Ltd.741
5Amgen Inc.630
6Novo Nordisk A/S620
7Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized620
8AstraZeneca UK Limited610
9Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
10Guangdong Heng Rui Pharmaceuticals 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

130 this week

AcceptedDrugApplicants
2025/08/05Import · Class 2.2 Lebrikizumab注射液 · No verified English nameJXSL2500140 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/08/05Import · Class 1 AZD0486 · No verified English nameJXSL2500139 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/05Import · Class 1 AZD0486 · No verified English nameJXSL2500138 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/08/05Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2502823 CISEN PHARMACEUTICAL CO., LTD.
2025/08/05Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2502821 Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2025/08/05Generic · Class 3 异丙托溴铵沙丁胺醇吸入喷雾剂 · No verified English nameCYHS2502820 Nanchang Gu Sen Biopharmaceutical Co., Ltd. romanized
2025/08/05Generic · Class 3 Ebastine Oral SolutionCYHS2502814 Chongqing Xi Er An Pharma Co., Ltd. romanized
2025/08/05Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502813 Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized
2025/08/05New drug · Class 2.3 小儿肺热咳喘口服液 · No verified English nameCXZL2500062 Heilongjiang Kui Hua Pharma Co., Ltd. romanized
2025/08/05New drug · Class 1 QLS2309注射液 · No verified English nameCXSL2500659 Qilu Pharmaceutical Co., Ltd.
2025/08/05New drug · Class 1 SYS6010 · No verified English nameCXSL2500658 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 IBI3009 · No verified English nameCXSL2500657 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/08/05New drug · Class 1 SYS6043 · No verified English nameCXSL2500656 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 DP303c注射液 · No verified English nameCXSL2500655 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 1 SYS6002 · No verified English nameCXSL2500654 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/08/05New drug · Class 3.3 精蛋白人胰岛素混合注射液(30R) · No verified English nameCXSL2500653 Heng Jing He Chuang Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2025/08/05New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500091 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/08/05New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHS2500090 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
2025/08/05New drug · Class 1 SYH2061注射液 · No verified English nameCXHL2500812 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized; CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2025/08/05New drug · Class 1 HRS-2430注射液 · No verified English nameCXHL2500811 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/05New drug · Class 1 HRS-2430注射液 · No verified English nameCXHL2500810 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/08/05New drug · Class 2.4 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2500809 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/08/05New drug · Class 2.2 DM2080贴 · No verified English nameCXHL2500808 Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized
2025/08/05New drug · Class 2.2 DM2080贴 · No verified English nameCXHL2500807 Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized
2025/08/05New drug · Class 2.3 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHL2500806 Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized
2025/08/04Generic · Class 3 Polaprezinc GranulesCYHS2502808 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized
2025/08/04Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2502807 Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2025/08/04Generic · Class 3 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502806 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/08/04Generic · Class 3 中性低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502805 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/08/04Generic · Class 3 Magnesium Sulfate InjectionCYHS2502804 Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized

100 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.