YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 416 drug applications between 4 September 2026 and 10 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 54 drug names.
2026/09/04 – 2026/09/10
- New acceptances this week
- 416
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 336
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, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 249 |
| New drug | 79 |
| Generic | 66 |
| Import | 13 |
| Import re-registration | 5 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 145 |
| Therapeutic biologic | 75 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
54 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 | 富马酸奥赛利定注射液 · No verified English name | 3 | 1 | 3 |
| 3 | Dotinurad Tablets | 2 | 1 | 55 |
| 4 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 5 | Nilotinib Capsules | 2 | 1 | 6 |
| 6 | Ticagrelor Tablets | 2 | 1 | 10 |
| 7 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 8 | Fexofenadine Hydrochloride Tablets | 2 | 1 | 10 |
| 9 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
| 10 | Adapalene And Benzoyl Peroxide Gel | 2 | 1 | 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
257 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 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Shenzhen Han Yu Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Jiangxi Hua Tai Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | Jilin Yu Ren Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Sichuan De Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Xizang Jin Ha Da Pharma 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/09/10New drug · Class 1 | INT-1868片 · No verified English nameCXHL2601106 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/09/10New drug · Class 1 | INT-1868片 · No verified English nameCXHL2601105 | Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/09/09Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2602252 | Shanxi Cheng Ze Yuan Bio Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/09Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2602251 | Shandong Nuo He Kang Pharma Co., Ltd. romanized |
| 2026/09/09Generic · Class 3 | Triamcinolone Acetonide and Econazole Nitrate CreamCYHS2602250 | Jiangsu Hua Han Pharmaceuticals Technology Co., Ltd. romanized; TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2026/09/09New drug · Class 1 | 注射用SAL02681 · No verified English nameCXSL2600984 | Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | UGX202注射液 · No verified English nameCXSL2600983 | Suzhou Xing Ming You Jian Bio Technology Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | 注射用SAL02682 · No verified English nameCXSL2600982 | Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | SQ-25042眼内注射溶液 · No verified English nameCXSL2600981 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | SQ-25042眼内注射溶液 · No verified English nameCXSL2600980 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | SQ-25042眼内注射溶液 · No verified English nameCXSL2600979 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | 异体3D间充质基质细胞注射液 · No verified English nameCXSL2600978 | Jian Yuan (Beijing) Zai Sheng Yi Xue Technology Co., Ltd. romanized; Zhang Jia Kou Jian Yuan Jing Zhun Yi Xue Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | 瑞普泊肽注射液 · No verified English nameCXHS2600129 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | 瑞普泊肽注射液 · No verified English nameCXHS2600128 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | 注射用GGA-sNIR · No verified English nameCXHL2601104 | Guangzhou Shi Yun Bio Technology Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | ZL-65片 · No verified English nameCXHL2601103 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | ZL-65片 · No verified English nameCXHL2601102 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/09New drug · Class 1 | ZL-65片 · No verified English nameCXHL2601101 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
87 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.