YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 240 drug applications between 5 July 2022 and 11 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 34 drug names.
2022/07/05 – 2022/07/11
- New acceptances this week
- 240
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 1
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
240filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| Generic | 45 |
| New drug | 33 |
| Import | 25 |
| Import re-registration | 17 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| Therapeutic biologic | 34 |
| TCM | 21 |
| Biologic | 5 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 2 | Hydromorphone Hydrochloride Extended-Release Tablets | 3 | 1 | 0 |
| 3 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 4 | Indobufen Tablets | 2 | 1 | 6 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 7 | Escitalopram Oxalate Tablets | 2 | 1 | 6 |
| 8 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 9 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 10 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 1 | 1 | 3 |
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
144 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 8 | 8 | 0 |
| 2 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 3 |
| 3 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 4 | 3 |
| 4 | Novo Nordisk A/S | 5 | 4 | 0 |
| 5 | LES LABORATOIRES SERVIER | 5 | 3 | 0 |
| 6 | AstraZeneca UK Limited | 5 | 2 | 0 |
| 7 | CSL Behring GmbH | 5 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 9 | F. Hoffmann-La Roche Ltd | 4 | 2 | 0 |
| 10 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200118 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200117 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200116 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200115 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200114 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201047 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201046 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201045 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Terlipressin Acetate InjectionCYHS2201042 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201041 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201040 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Florbetaben F-18 InjectionCYHS2201037 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Mometasone Furoate CreamCYHS2201026 | Fu Yuan Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200057 | Qilu Pharmaceutical Co., Ltd. |
| 2022/07/11Generic · Class 3 | 盐酸溴己新雾化吸入溶液 · No verified English nameCYHL2200056 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2022/07/11New drug · Class 3.3 | 注射用依那西普 · No verified English nameCXSS2200063 | Qilu Pharmaceutical Co., Ltd. |
| 2022/07/11New drug · Class 1 | BC008-1A注射液 · No verified English nameCXSL2200315 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2022/07/11New drug · Class 1 | PM1009注射液 · No verified English nameCXSL2200312 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/07/11New drug · Class 1 | 注射用KH617 · No verified English nameCXHL2200491 | Sichuan Hong He Bio Technology Co., Ltd. romanized |
| 2022/07/08Generic · Class 3 | Ornidazole InjectionCYHS2201034 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2022/07/08Generic · Class 3 | Ornidazole InjectionCYHS2201033 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2022/07/08Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2201032 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2022/07/08Generic · Class 3 | Arbidol Hydrochloride TabletsCYHS2201031 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/07/08New drug · Class 1 | SHR8554注射液 · No verified English nameCXHS2200038 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/07/08New drug · Class 1 | SHR8554注射液 · No verified English nameCXHS2200037 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/07/07Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSL2200113 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/07Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSL2200112 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/07Import · Class 1 | Modakafusp Alfa注射液(TAK-573) · No verified English nameJXSL2200111 | Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/07/07Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2200110 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2022/07/07Import · Class 1 | MK-4830注射液 · No verified English nameJXSL2200109 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
39 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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