YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 416 drug applications between 5 September 2026 and 11 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 51 drug names.
2026/09/05 – 2026/09/11
- New acceptances this week
- 416
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 351
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
416filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 256 |
| New drug | 78 |
| Generic | 65 |
| Import | 11 |
| Import re-registration | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 178 |
| TCM | 149 |
| Therapeutic biologic | 82 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
| In vitro diagnostic reagent | 1 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 2 | Oseltamivir Phosphate Capsules | 3 | 2 | 39 |
| 3 | 富马酸奥赛利定注射液 · No verified English name | 3 | 1 | 3 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 6 | Nilotinib Capsules | 2 | 1 | 6 |
| 7 | Ticagrelor Tablets | 2 | 1 | 10 |
| 8 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 9 | Fexofenadine Hydrochloride Tablets | 2 | 1 | 10 |
| 10 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
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
255 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Shaanxi Ou Ke Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Shenzhen Han Yu Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Jiangxi Hua Tai Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Jilin Yu Ren Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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 |
|---|---|---|
| 2026/09/11Import · Class 1 | LY4405094注射液 · No verified English nameJXSL2600242 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD |
| 2026/09/11Import · Class 2.2 | 乌帕替尼口服溶液 · No verified English nameJXHL2600401 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2026/09/11Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHL2600400 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/09/11Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2602272 | Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized |
| 2026/09/11Generic · Class 3 | Netilmicin Sulfate InjectionCYHS2602268 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2026/09/11New drug · Class 3.1 | 温胆汤颗粒 · No verified English nameCXZS2600049 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized |
| 2026/09/11New drug · Class 1.1 | 夏黄颗粒 · No verified English nameCXZL2600090 | Yi You Bio (Shanghai) Co., Ltd. romanized; Meng Yang Pharma (Shanghai) Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSS2600150 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized; Name not romanized |
| 2026/09/11New drug · Class 1 | TQH2722注射液 · No verified English nameCXSS2600149 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/09/11New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2600148 | Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600995 | An Ming Kang Yuan Pharmaceutical (Jilin) Co., Ltd. romanized; An Kang Yuan Bio Technology (Jilin) Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | 注射用SHR-1219 · No verified English nameCXSL2600994 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | SYS6065 · No verified English nameCXSL2600993 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | JY2002注射液 · No verified English nameCXSL2600992 | Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600991 | Jiangsu Sai Yi Bio Technology Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | IBI354 · No verified English nameCXSL2600990 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | BL0175注射液 · No verified English nameCXHL2601109 | Shanghai Bi Ling Bio Technology Co., Ltd. romanized |
| 2026/09/11New drug · Class 1 | HTD1801胶囊 · No verified English nameCXHL2601108 | Shanghai Fu Yao Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2026/09/10Import · Class 2.1; 2.2 | 索特西普注射液 · No verified English nameJXSL2600241 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/09/10Import · Class 1 | NCX 470滴眼液 · No verified English nameJXHS2600105 | OCUMENSION(HONG KONG)LIMITED; Alliance Medical Products Inc. (dba. Siegfried Irvine); Ocumension Therapeutics(Suzhou)Co. Ltd. |
| 2026/09/10Generic · Class 3 | Bilastine Oral SolutionCYHS2602267 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/09/10Generic · Class 3 | 盐酸奥洛他定口崩片 · No verified English nameCYHS2602266 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized |
| 2026/09/10Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2602261 | Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/09/10New drug · Class 3.1 | 温胆汤颗粒 · No verified English nameCXZS2600048 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2026/09/10New drug · Class 1.3 | 三价流感重组蛋白疫苗 · No verified English nameCXSL2600989 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2026/09/10New drug · Class 1.3 | 三价流感重组蛋白疫苗 · No verified English nameCXSL2600988 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2026/09/10New drug · Class 1 | HLX109注射液 · No verified English nameCXSL2600987 | Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized |
| 2026/09/10New drug · Class 1 | KHN923注射液 · No verified English nameCXSL2600986 | Chengdu Kang Hong Bio Technology Co., Ltd. romanized |
| 2026/09/10New drug · Class 1 | MTS109注射液 · No verified English nameCXSL2600985 | Ji Tai Technology (Beijing) Co., Ltd. romanized; Beijing Ji Tai Sheng Ming Technology Co., Ltd. romanized |
| 2026/09/10New drug · Class 1 | INT-1868片 · No verified English nameCXHL2601107 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.