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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 383 drug applications between 11 May 2025 and 17 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 77 drug names.

2025/05/11 – 2025/05/17

Period
2025/05/11 to 2025/05/17, 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)
77
Accepted this week, now under review
59

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, 109 of them generic

By application type

Application typeFilings
Supplement189
Generic109
New drug53
Import20
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug257
TCM61
Therapeutic biologic61
Biologic2
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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Minoxidil Liniment4252
3Risperidone Oral Solution416
4Calcium Acetate Oral Solution411
5Aripiprazole Oral Solution414
6Brexpiprazole Tablets3131
7Drotaverine Hydrochloride Injection223
8Metoclopramide Hydrochloride Injection226
9维生素B12注射液 · No verified English name226
10Oxcarbazepine Tablets214

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
2Hong Tao Kai Pharma Co., Ltd. romanized660
3Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
4Sanofi Winthrop Industrie610
5Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
6AstraZeneca AB540
7Guangdong Sunho Pharmaceutical Co., Ltd.522
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Qilu Pharmaceutical Co., Ltd.520
10Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510

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

124 this week

AcceptedDrugApplicants
2025/05/17Import · Class 1 AMG 890 · No verified English nameJXHL2500115 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/05/17Import · Class 1 AMG 890 · No verified English nameJXHL2500114 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2025/05/17Import · Class 2.4 匹妥布替尼片 · No verified English nameJXHL2500113 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/05/17Import · Class 1 Rilzabrutinib片 · No verified English nameJXHL2500112 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/05/17Generic · Class 3 Brivaracetam TabletsCYHS2501808 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/05/17Generic · Class 3 Brivaracetam TabletsCYHS2501807 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/05/17Generic · Class 3 Potassium Chloride Oral SolutionCYHS2501803 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2025/05/17Generic · Class 3 维生素B12注射液 · No verified English nameCYHS2501802 Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2025/05/17Generic · Class 3 硝酸咪康唑乳膏 · No verified English nameCYHS2501801 Suzhou Gao Mai Pharma Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
2025/05/17Generic · Class 3 Zonisamide Oral SuspensionCYHS2501795 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2025/05/17Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2501794 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/05/17Generic · Class 3 Amikacin Sulfate injectionCYHS2501791 Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized
2025/05/17Generic · Class 3 Folic Acid TabletsCYHS2501789 Anhui Sheng Ying Pharma Co., Ltd. romanized
2025/05/17Generic · Class 3 Amikacin Sulfate injectionCYHS2501788 Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized
2025/05/17New drug · Class 2.2 菖麻熄风颗粒 · No verified English nameCXZS2500020 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2025/05/17New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500393 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/17New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500392 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/17New drug · Class 1 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2500390 Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized; Shenzhen Fu Nuo Jian Bio Technology Co., Ltd. romanized
2025/05/17New drug · Class 1 SCT640C注射液 · No verified English nameCXSL2500389 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/17New drug · Class 2.2 1536A · No verified English nameCXHL2500484 Beijing Kang Lian Zhi Hui Technology Co., Ltd. romanized
2025/05/16Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501787 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized
2025/05/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501786 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501785 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 福多司坦片 · No verified English nameCYHS2501784 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2025/05/16Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2501777 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized
2025/05/16New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2500019 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2025/05/16New drug · Class 1 ABO2102注射剂 · No verified English nameCXSL2500388 Suzhou Ai Bo Bio Technology Co., Ltd. romanized; Ai Bo Bio Technology (Shanghai) Co., Ltd. romanized
2025/05/16New drug · Class 1 GB261注射液 · No verified English nameCXSL2500387 Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized; Jia He Bio Pharma Co., Ltd. romanized
2025/05/16New drug · Class 1 NW-101C注射液 · No verified English nameCXSL2500386 Xin Jing Zhi Yuan Bio Technology (Suzhou) Co., Ltd. romanized
2025/05/16New drug · Class 1 NW-101C注射液 · No verified English nameCXSL2500385 Xin Jing Zhi Yuan Bio Technology (Suzhou) Co., Ltd. romanized

94 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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