YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 518 drug applications between 3 February 2026 and 9 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 55 drug names.
2026/02/03 – 2026/02/09
- New acceptances this week
- 518
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 122
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
518filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 332 |
| Generic | 78 |
| New drug | 73 |
| Unspecified | 13 |
| Import re-registration | 12 |
| Import | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 219 |
| Therapeutic biologic | 55 |
| Biologic | 6 |
| Prophylactic biologic | 2 |
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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 3 | Cyclophosphamide Injection | 3 | 1 | 6 |
| 4 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 5 | Ibuprofen Suspension | 2 | 2 | 14 |
| 6 | 氧 · No verified English name | 2 | 2 | 15 |
| 7 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 8 | Fluticasone Propionate Cream | 2 | 1 | 12 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
211 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 123 | 95 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 34 | 17 | 0 |
| 3 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 21 | 20 | 0 |
| 4 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 5 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 9 | 2 | 0 |
| 6 | AstraZeneca AB | 7 | 4 | 0 |
| 7 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | PHARMATHEN INVESTMENTS GROUP LIMITED | 5 | 1 | 0 |
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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/09New drug · Class 1 | 注射用BG-T187(皮下注射) · No verified English nameCXSL2600197 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | LY-M003注射液 · No verified English nameCXSL2600187 | Ling Yi (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | IBI115 · No verified English nameCXSL2600186 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | QLS7320注射液 · No verified English nameCXHL2600167 | Qilu Pharmaceutical Co., Ltd. |
| 2026/02/09New drug · Class 1 | QLS7320注射液 · No verified English nameCXHL2600166 | Qilu Pharmaceutical Co., Ltd. |
| 2026/02/09New drug · Class 1 | QLS7320注射液 · No verified English nameCXHL2600165 | Qilu Pharmaceutical Co., Ltd. |
| 2026/02/09New drug · Class 1 | 注射用华卟啉钠 · No verified English nameCXHL2600161 | Shanghai Guang Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | JY54注射液 · No verified English nameCXHL2600160 | Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/09New drug · Class 2.4 | 安奈拉唑钠肠溶片 · No verified English nameCXHL2600159 | Xuan Zhu (Beijing) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | HS-10522片 · No verified English nameCXHL2600158 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | HS-10522片 · No verified English nameCXHL2600157 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | HS-10522片 · No verified English nameCXHL2600156 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/09New drug · Class 1 | WS-0101溶液 · No verified English nameCXHL2600155 | Name not romanized |
| 2026/02/08Import · Class 3.1 | 重组呼吸道合胞病毒疫苗(CHO细胞,AS01E佐剂系统) · No verified English nameJXSS2600008 | GlaxoSmithKline Biologicals SA; GlaxoSmithKline Biologicals; GlaxoSmithKline (China) Investment Company Limited |
| 2026/02/07Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2600035 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2600034 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Import · Class 2.4 | 依普隆特生钠注射液 · No verified English nameJXHL2600033 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/02/07Generic · Class 3 | Ferrous Succinate TabletsCYHS2600404 | Beijing Ren Zhong Pharma Co., Ltd. romanized |
| 2026/02/07Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2600403 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized |
| 2026/02/07New drug · Class 2.3 | 西帕依麦孜彼子口服液 · No verified English nameCXZL2600022 | Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized; Qi Mu (Guangdong Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/07New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2600016 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized |
| 2026/02/07New drug · Class 1 | ALXN2220注射液 · No verified English nameCXSL2600185 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/02/07New drug · Class 1 | ZHB117舌下片 · No verified English nameCXSL2600184 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/02/07New drug · Class 1 | ZHB117舌下片 · No verified English nameCXSL2600183 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2026/02/07New drug · Class 1 | 注射用GLR1059 · No verified English nameCXSL2600182 | Gan Li Pharma Co., Ltd. romanized |
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液 · No verified English nameJXSS2600007 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液 · No verified English nameJXSS2600006 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 2.4 | 宗艾替尼片 · No verified English nameJXHL2600032 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/02/06Generic · Class 3 | Amikacin Sulfate injectionCYHS2600409 | Shandong An Xin Pharmaceutical Co., Ltd. romanized; Qilu Pharmaceutical Co., Ltd. |
| 2026/02/06Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2600398 | Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized |
81 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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