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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 331 drug applications between 19 May 2026 and 25 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 18 drug names.

2026/05/19 – 2026/05/25

Period
2026/05/19 to 2026/05/25, 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
331
Drugs with new generic filings (by drug name, de-duplicated)
18
Accepted this week, now under review
38

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

331filings, 23 of them generic

By application type

Application typeFilings
Supplement218
New drug66
Generic23
Import10
Unspecified7
Import re-registration7

By drug type

Drug typeFilings
TCM164
Chemical drug118
Therapeutic biologic48
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel3230
2复方醋酸钠葡萄糖注射液 · No verified English name218
3Levofloxacin and Sodium Chloride Injection2114
4Procaterol Hydrochloride Oral Solution2112
5Upadacitinib Sustained-release Tablets1143
6Crisaborole Ointment1126
7Carbetocin Injection116
8双氯芬酸钠盐酸利多卡因注射液 · No verified English name118
9噻托溴铵奥达特罗吸入喷雾剂 · No verified English name112
10Ibuprofen Suspension1114

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Da Tang Pharmaceutical Group Co., Ltd. romanized10100
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1050
3Tong Hua Jin Ma Pharma Group Co., Ltd. romanized870
4Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
5Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550
6Hunan De Kang Pharmaceutical Co., Ltd. romanized550
7EUROAPI Germany GmbH440
8Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized440
9Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
10Hubei Dong Xin Pharma Co., Ltd. romanized440

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

80 this week

AcceptedDrugApplicants
2026/05/25Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600120 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/05/25Import · Class 1 PFL-721片 · No verified English nameJXHL2600184 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/05/25Import · Class 1 PFL-721片 · No verified English nameJXHL2600183 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/05/25New drug · Class 3.1 清心莲子饮颗粒 · No verified English nameCXZS2600027 Yunnan Bai Yao Group Co., Ltd. romanized
2026/05/25New drug · Class 1 NK细胞注射液 · No verified English nameCXSL2600569 Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 RJK-RT2831注射液 · No verified English nameCXSL2600568 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 Tvac001新抗原反应性T细胞注射液 · No verified English nameCXSL2600567 Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 SGC001注射液 · No verified English nameCXSL2600566 Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600625 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/05/25New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600624 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/05/25New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600623 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/05/25New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600622 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/05/25New drug · Class 1 注射用Tvac001个性化肿瘤新抗原多肽 · No verified English nameCXHL2600621 Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 HZ-V055胶囊 · No verified English nameCXHL2600620 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/05/25New drug · Class 1 HZ-V055胶囊 · No verified English nameCXHL2600619 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/05/25New drug · Class 1 HZ-V055胶囊 · No verified English nameCXHL2600618 Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/05/22Import · Class 1 DDY391片 · No verified English nameJXHL2600182 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/22Import · Class 1 DDY391片 · No verified English nameJXHL2600181 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/22Import · Class 1 BMS-986458片 · No verified English nameJXHL2600180 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/05/22Import · Class 1 BMS-986458片 · No verified English nameJXHL2600179 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/05/22New drug · Class 1.1 黄氏止咳润喉散 · No verified English nameCXZL2600048 Huang Shi Hou Kang Zhong Pharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 注射用BL-B01D1(皮下注射) · No verified English nameCXSL2600565 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 HH160注射液 · No verified English nameCXSL2600564 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 GEB-101 · No verified English nameCXSL2600563 Beijing Yin Zheng Ji Yin Technology Co., Ltd. romanized
2026/05/22New drug · Class 1 注射用3SC009 · No verified English nameCXSL2600562 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/05/22New drug · Class 1 QX027N 注射液 · No verified English nameCXSL2600561 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 QX027N 注射液 · No verified English nameCXSL2600560 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2026/05/22New drug · Class 1 GenSci144片 · No verified English nameCXHL2600617 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 GenSci144片 · No verified English nameCXHL2600616 Changchun Jin Sai Pharma Co., Ltd. romanized
2026/05/22New drug · Class 1 BIOS0635-048片 · No verified English nameCXHL2600615 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized

50 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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