YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 429 drug applications between 5 May 2026 and 11 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 39 drug names.
2026/05/05 – 2026/05/11
- New acceptances this week
- 429
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- Accepted this week, now under review
- 94
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
429filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 249 |
| New drug | 70 |
| Generic | 50 |
| Import | 39 |
| Unspecified | 14 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 155 |
| Therapeutic biologic | 66 |
| Biologic | 9 |
| Prophylactic biologic | 3 |
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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 2 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 3 | Lidocaine and Tetracaine Cream | 2 | 1 | 2 |
| 4 | Piracetam Injection | 2 | 1 | 9 |
| 5 | Dotinurad Tablets | 2 | 1 | 55 |
| 6 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 7 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 8 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 9 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 10 | Dapagliflozin Tablets | 2 | 1 | 84 |
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
250 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 21 | 3 | 0 |
| 2 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 12 | 8 | 0 |
| 3 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 10 | 9 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 9 | 4 | 1 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Pfizer Inc. | 5 | 4 | 0 |
| 9 | Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Shandong Xian He Pharma Co., Ltd. romanized | 5 | 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/11Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2600060 | Beijing Hua Su Pharmaceutical Co., Ltd. romanized |
| 2026/05/11Generic · Class 3 | Lidocaine and Tetracaine CreamCYHL2600059 | Beijing Hua Su Pharmaceutical Co., Ltd. romanized |
| 2026/05/11New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSS2600082 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2026/05/11New drug · Class 2.2 | 纳基奥仑赛注射液 · No verified English nameCXSS2600081 | He Yuan Bio Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | KBD102430片 · No verified English nameCXHL2600560 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | KBD102430片 · No verified English nameCXHL2600559 | Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | 比瑞替尼片 · No verified English nameCXHL2600558 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | GW5282片 · No verified English nameCXHL2600555 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | GW5282片 · No verified English nameCXHL2600553 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized |
| 2026/05/11New drug · Class 1 | GFH276片 · No verified English nameCXHL2600552 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/11New drug · Class 2.4 | 索托克拉片 · No verified English nameCXHL2600551 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 2.4 | 索托克拉片 · No verified English nameCXHL2600550 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 2.4 | 索托克拉片 · No verified English nameCXHL2600549 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/05/11New drug · Class 2.4 | 索托克拉片 · No verified English nameCXHL2600548 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/05/10Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHL2600057 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2026/05/10New drug · Class 1.1 | 通降颗粒 · No verified English nameCXZS2600025 | Jian Min Pharma Group Co., Ltd. romanized |
| 2026/05/10New drug · Class 1 | Cizutamig注射液 · No verified English nameCXSL2600489 | Shanghai Tan Di Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/10New drug · Class 1 | IG4001肠溶片 · No verified English nameCXHL2600547 | Suzhou Dian Shi Zhi Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/09Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2600041 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液 · No verified English nameJXSL2600114 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液 · No verified English nameJXSL2600113 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 注射用替奈普酶 · No verified English nameJXSL2600112 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD2265 · No verified English nameJXHL2600162 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600161 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600160 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600159 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Generic · Class 3 | Acetylcysteine InjectionCYHS2601066 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2601064 | Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601058 | Anhui Huan Qiu Pharma Co., Ltd. romanized |
86 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.