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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 360 drug applications between 13 May 2025 and 19 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 74 drug names.

2025/05/13 – 2025/05/19

Period
2025/05/13 to 2025/05/19, 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
360
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
53

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

360filings, 102 of them generic

By application type

Application typeFilings
Supplement180
Generic102
New drug52
Import18
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug241
Therapeutic biologic60
TCM53
Prophylactic biologic4
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

74 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
2Risperidone Oral Solution416
3Calcium Acetate Oral Solution411
4Aripiprazole Oral Solution414
5Drotaverine Hydrochloride Injection223
6Metoclopramide Hydrochloride Injection226
7维生素B12注射液 · No verified English name226
8Oxcarbazepine Tablets214
9Vonoprazan Fumarate Tablets2160
10Levofloxacin and Sodium Chloride Injection2114

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized13413
2Qilu Pharmaceutical Co., Ltd.730
3Hong Tao Kai Pharma Co., Ltd. romanized660
4Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
5Sanofi Winthrop Industrie610
6Guangdong Sunho Pharmaceutical Co., Ltd.522
7Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized520
8Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
9Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized510
10Hainan Hai Li Pharmaceutical Co., Ltd. romanized441

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

118 this week

AcceptedDrugApplicants
2025/05/19Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2501810 Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized
2025/05/19New drug · Class 1 CM512注射液 · No verified English nameCXSL2500397 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/05/19New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500396 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/19New drug · Class 1 SCTB14注射液 · No verified English nameCXSL2500395 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2025/05/19New drug · Class 1 SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2500394 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2025/05/19New drug · Class 1 CM512注射液 · No verified English nameCXSL2500391 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/05/19New drug · Class 2.2 QLM2012 · No verified English nameCXHL2500489 Qilu Pharmaceutical Co., Ltd.
2025/05/19New drug · Class 2.2 QLM2012 · No verified English nameCXHL2500488 Qilu Pharmaceutical Co., Ltd.
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

88 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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