YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 545 drug applications between 3 January 2026 and 9 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 91 drug names.
2026/01/03 – 2026/01/09
- New acceptances this week
- 545
- Drugs with new generic filings (by drug name, de-duplicated)
- 91
- Accepted this week, now under review
- 186
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
545filings, 135 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 236 |
| New drug | 142 |
| Generic | 135 |
| Unspecified | 16 |
| Import | 13 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 329 |
| TCM | 107 |
| Therapeutic biologic | 97 |
| Biologic | 6 |
| Prophylactic biologic | 6 |
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
91 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 6 | 4 | 69 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 4 | Brivaracetam Tablets | 4 | 1 | 19 |
| 5 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 3 | 2 | 15 |
| 6 | Mometasone Furoate Cream | 3 | 1 | 16 |
| 7 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 8 | Levonorgestrel Tablets | 2 | 2 | 5 |
| 9 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 10 | Mupirocin Ointment | 2 | 2 | 30 |
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
308 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 13 | 2 | 0 |
| 3 | Sichuan Tian De Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Gan Li Pharma Shandong Co., Ltd. romanized | 9 | 1 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 7 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 8 | Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 6 | 2 | 6 |
| 10 | Name not romanized | 6 | 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
186 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/09Import · Class 2.4 | 宗艾替尼片 · No verified English nameJXHL2600008 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/01/09Generic · Class 3 | Metformin Hydrochloride Oral SolutionCYHS2600123 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/01/09Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2600116 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/01/09Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2600112 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2026/01/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2600110 | Hua Ren Pharma (Ri Zhao) Co., Ltd. romanized |
| 2026/01/09Generic · Class 3 | 盐酸伊伐布雷定口服溶液 · No verified English nameCYHS2600105 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/01/09Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2600101 | Shaanxi Xiang Ju Pharma Group Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/01/09Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2600004 | Fu Yuan Pharma Co., Ltd. romanized |
| 2026/01/09New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2600006 | Hua Lan An Kang Bio Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | GR1803注射液 · No verified English nameCXSS2600003 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | SCTC21C注射液 · No verified English nameCXSL2600049 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/01/09New drug · Class 1.2 | YKYY026注射液 · No verified English nameCXSL2600048 | Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | 注射用BR2060 · No verified English nameCXSL2600047 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.2 | 注射用维贝柯妥塔单抗 · No verified English nameCXSL2600046 | Le Pu Bio Technology Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | LAE102注射液 · No verified English nameCXSL2600045 | Lai Kai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600042 | Name not romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600041 | Name not romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600040 | Name not romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600039 | Name not romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600038 | Name not romanized |
| 2026/01/09New drug · Class 1 | 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600037 | Name not romanized |
| 2026/01/09New drug · Class 1 | SCTB41注射液 · No verified English nameCXSL2600035 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.6 | 吸附无细胞百白破(组分)联合疫苗(成人青少年及儿童用) · No verified English nameCXSL2600034 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.4 | Nalbuphine Hydrochloride InjectionCXHS2600013 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.4 | Nalbuphine Hydrochloride InjectionCXHS2600012 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.4 | Nalbuphine Hydrochloride InjectionCXHS2600011 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/01/09New drug · Class 1 | 丁二酸复瑞替尼胶囊 · No verified English nameCXHS2600010 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2026/01/09New drug · Class 2.3 | 普卢格列汀二甲双胍缓释片 · No verified English nameCXHS2600009 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/01/09New drug · Class 2.3 | 普卢格列汀二甲双胍缓释片 · No verified English nameCXHS2600008 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/01/09New drug · Class 1 | QLS1317片 · No verified English nameCXHL2600057 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
156 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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